U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implanted Infusion Pump - Product Code LKK
Causa
The sc catheters cannot completely engage with the model 700-04m portal connector. the result of this condition is a possible leakage or disconnect of the sc catheter from the portal during the continuous therapy trial period.
Acción
Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implanted Infusion Pump - Product Code LKK
Causa
The sc catheters cannot completely engage with the model 700-04m portal connector. the result of this condition is a possible leakage or disconnect of the sc catheter from the portal during the continuous therapy trial period.
Acción
Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
implantable infusion pump - Product Code LKK
Causa
Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of medtronic model 8647 synchromed ii pumps that was communicated with healthcare providers in july 2009. the purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize.
Acción
Medtronic Neuromodulation notified physicians with an Urgent Medical Device Correction letter beginning July 05, 2011. A press was issued July 08, 2011. The letter described the issue, severity, recommendations if they notice issue, and patient management recommendations.
UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic has confirmed that an algorithm used in the model 8870 application card software has resulted
in nine (9) occurrences of an incorrectly displayed schedule to replace the pump by date. it is estimated that there are more than 140,000 synchromed ii pump implants worldwide. a patient with a pump reaching eos prior to replacement may experience the return of underlying symptoms and/or
wit.
Acción
Medtronic mailed an "Urgent Medical Device Correction " letter addressed to Dear Healthcare Professional on March 12, 2012. The letter described the problem, Background, Clinical Manifestations, Recommendations, and Additional Information.
To ensure there is no interruption in therapy, pump replacements should be scheduled before the ERI alarm sounds and the pump reaches its 7-year end of service.
Customers were advised to forward the Urgent Medical Device Correction letter to patients whose name appears on their Pump Replacement List.
Reimbursement SupportFor assistance with prior authorization, contact Medtronic Reimbursement at the numbers below:
Therapy for Severe Spasticity: (800) 292-2903
Pain Therapies: (866) 962-9909
For questions regarding the letter call 800-328-0810.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic notified healthcare professionals of the impact of unapproved drugs on the performance of the synchromed infusion pump system. use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.
update 2/1/2016: medtronic received approval to incorporate enhancements to the synchromed ii pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
Acción
The firm Medtronic, sent an "Urgent medical Device Safety Notification" dated November 2012, to its customers beginning November 09, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to follow the recommendations provided in the letter and complete and return the PHYSICIAN REPLY FORM via mail at Medtronic Neuromodulation Quality Assurance, 7000 Central Ave NE, Mailstop RCC150, Minneapolis, MN 55432; fax to: 800-897-3899 or email to: neuro.quality@medtronic.com.
If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
UPDATE 2/1/2016: Medtronic began notifying consignees 2/1/2016 via, mail, telephone and/or in person visit by a Medtronic Field Representative. The Medtronic Field Representatives will retrieve devices in the US and provide an Urgent Medical Device Removal letter. The letter states that device design has been updated and the Medtronic Field Representative has retrieved any devices with a Use By date on or before 5/14/2017. An account specific Customer Confirmation Form was to be completed by either the Medtronic Field Representative or the consignee. Consignees with questions can contatct their Medtronic Field Representative, or Customer Service at 1-888-854-0978.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic notified healthcare professionals of the impact of unapproved drugs on the performance of the synchromed infusion pump system. use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.
update 2/1/2016: medtronic received approval to incorporate enhancements to the synchromed ii pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
Acción
The firm Medtronic, sent an "Urgent medical Device Safety Notification" dated November 2012, to its customers beginning November 09, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to follow the recommendations provided in the letter and complete and return the PHYSICIAN REPLY FORM via mail at Medtronic Neuromodulation Quality Assurance, 7000 Central Ave NE, Mailstop RCC150, Minneapolis, MN 55432; fax to: 800-897-3899 or email to: neuro.quality@medtronic.com.
If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
UPDATE 2/1/2016: Medtronic began notifying consignees 2/1/2016 via, mail, telephone and/or in person visit by a Medtronic Field Representative. The Medtronic Field Representatives will retrieve devices in the US and provide an Urgent Medical Device Removal letter. The letter states that device design has been updated and the Medtronic Field Representative has retrieved any devices with a Use By date on or before 5/14/2017. An account specific Customer Confirmation Form was to be completed by either the Medtronic Field Representative or the consignee. Consignees with questions can contatct their Medtronic Field Representative, or Customer Service at 1-888-854-0978.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic is providing healthcare professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromed implantable infusion pump. the unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
Acción
Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the background and nature of the issue and provided recommendations for patient management and monitoring after initiation of Intrathecal Therapy. The letter directed customers to continue to use the priming bolus precedure; to monitor all patients following start or restart of intrathecal therapy; consider priming the pump prior to implant; and educate caregivers and family members to recognize the signs and sypmtoms associated with intrathecal drug therapy complications. For questions contact your local Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic is providing healthcare professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromed implantable infusion pump. the unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
Acción
Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the background and nature of the issue and provided recommendations for patient management and monitoring after initiation of Intrathecal Therapy. The letter directed customers to continue to use the priming bolus precedure; to monitor all patients following start or restart of intrathecal therapy; consider priming the pump prior to implant; and educate caregivers and family members to recognize the signs and sypmtoms associated with intrathecal drug therapy complications. For questions contact your local Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic neuromodulation is providing healthcare providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they synchromed infusion pump. an electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und.
Acción
Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. The Medtronic Rep would complete a Physician Notification Confirmation Form. A copy of the recall notification letter and the completed Confirmation Form is to be left with the physician. Customers with questions were instructed to call 1-800-707-0933.
For questions regarding this recall call 763-526-9738.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic neuromodulation is providing healthcare providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they synchromed infusion pump. an electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und.
Acción
Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. The Medtronic Rep would complete a Physician Notification Confirmation Form. A copy of the recall notification letter and the completed Confirmation Form is to be left with the physician. Customers with questions were instructed to call 1-800-707-0933.
For questions regarding this recall call 763-526-9738.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall provides important new information regarding overinfusion associated with the medtronic synchromed ii implantable pump. overinfusion can result in a life-threatening overdose and
can also result in drug withdrawal due to premature emptying of the pump. due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk,
medtronic is not re.
Acción
Medtronic sent a "Urgent Medical Device Correction" letter dated March 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter provided the Explanation of the Issue, Scope and Severity, Recommendations, and Important Guidelines.
Customer visits were started by Medtronic field Representatives on February 26th, 2014.
Medtronic is communicating this information to the appropriate regulatory agencies globally, including the U.S. Food and Drug Administration. We are committed to continuing to improve our product performance and services to enable you to manage your patients in a safe and effective manner. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am- 6pm CST.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic is removing specific lots of the ascenda intrathecal catheters and revision kits, which are used with the implantable synchromed drug infusion pump. this recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. there is a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconne.
Acción
Medtronic sent an Urgent Medical Device Removal letter dated July 11, 2014, to all affected customers. The letter described the issue, identified affected product, provided patient management recommendations for patients implanted with an affected device, asked for Risk Management to quaratine unused inventory within the hospital, and to contact Medtronic Customer Service at 1-888-638-7627 to facilitate return of devices.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning.Medtronic have found that the SynchroMed EL and SynchroMed II drug pumps do not behave as expected when they are exposed to the magnetic field of an MRI scan. The product labelling states that the magnetic field of an MRI scan will temporarily stop the rotor of the pump and suspend drug infusion for the duration of the MRI exposure for all SynchroMed pumps. The pump should resume normal operation when removed from the MRI magnetic field. However, the following issues have been found:potential delay in resumption of drug infusion following an MRI scan (both models)
potential for pump programming to be altered (both models)
delay in logging of motor stall in the pump memory (SynchroMed II only)
delay in detecting motor stall recovery (SynchroMed II only)There have been nine reported incidents of motor stall and 70 reports of event logging errors worldwide to date.No patient deaths or serious injuries have been reported as a result of these problems.
Causa
(medtronic) risk of delays in the resumption of drug infusion and in logging of motor stall events after mri scans. (mda/2008/087).
Acción
Ensure that departmental procedures are in place for the scanning of patients with Medtronic SynchroMed implantable drug pumps. Where prior consultation with pump management staff has not been possible, consider:alternative imaging techniques if appropriate
more regular observations of the patient until confirmation that the pump has restarted.For all personnel involved in the care of patients with these pumps:Follow manufacturer’s advice regarding these risks (see appendix)Before MRIEnsure that an assessment has been undertaken to determine whether the patient could be safely deprived of their drug for the duration of the scan and until the pump can be interrogated
Ensure there is a Medtronic N’Vision programmer available to interrogate the pump as soon as possible after an MRI scan (and X-ray facilities for roller study on SynchroMed EL)After MRIEnsure that the patient and pump are reviewed promptly following scanning to confirm that therapy has resumed and that pump programming has not been affected. This could include:
close observation for signs of drug underdosing
for patients implanted with SynchroMed II pumps, interrogate the pump with the N’Vision programmer. If motor stall and recovery has not been confirmed after a second interrogation, contact the manufacturer for further advice
for patients implanted with SynchroMed EL pumps, interrogate the pump to identify whether programming has been affected and consider carrying out a roller study (as described in the IFU) to confirm that drug infusion has resumed
Before carrying out any medical intervention (e.g. administering a drug bolus or explanting the pump) consider the possibility of extended motor stall
Do not discharge patients until you have verified that normal drug infusion has resumed
Contact the manufacturer for advice if in doubt about pump status
Report drug pump incidents to the manufacturer and the MHRA
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
MHRA is aware of five incidents in the United Kingdom where the use of diamorphine solution has resulted in malfunction of the SynchroMed® pump. In four of these incidents, pump malfunction led to cessation of drug delivery (motor stalling) resulting in return of patient symptoms. In the remaining incident (still under investigation) pump malfunction led to over-infusion of diamorphine solution and the patient suffered a cardiorespiratory arrest.Failure analysis of the four cases of motor stalling by Medtronic has shown that motor stalling was associated with the long-term administration of diamorphine solution, where the materials of the internal components were damaged. Diamorphine (diacetyl morphine) in aqueous solution will degrade over time, producing an insoluble active compound (6-monoacetyl morphine), which is an acetate and is believed to have caused the damage to the pump.Current Instructions for Use for the SynchroMed® implantable drug pump do not include diamorphine in the list of medications that are compatible with the pump.In October 2002 Medtronic distributed an “Educational Brief: Revised Drug Formulation SynchroMed® Infusion System”, which listed drugs and additives known to be incompatible with the SynchroMed® implantable drug pump. Diamorphine was not included in this listing since its adverse effect had not been recognised at that time. To clarify this situation Medtronic plans to distribute further information shortly.It is estimated that there are 1200 SynchroMed® drug pumps currently implanted in the UK.
Causa
(medtronic) diamorphine solution is incompatible with the implantable drug pump. (mda/2003/035).
Acción
For patients currently receiving diamorphine solution via the SynchroMed® pump, clinicians should consider :changing to an alternative medication compatible with the pump as soon as possible (note that changing the patient’s medication requires careful assessment and observation by experienced personnel);
elective replacement of the pump when patient management dictates.
Clinicians should be aware that other drugs are contraindicated for delivery via SynchroMed® implantable drug pumps. Where doubt exists, check the instructions for use as supplied with the pump, or seek manufacturer’s advice.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of drug under- or overdose due to various issues with these drug pumps.Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories:The first FSN (Manufacturer reference: FA573) confirms a serious risk associated with the priming bolus function. Unintentional mixing of drug and non-drug fluids (including cerebrospinal fluid and sterile water) during the priming bolus can pose a risk of overdose. A subsequent risk of underdose exists following administration of the priming bolus. Detailed advice on the management of patients during pump priming is provided in FA573.
The second FSN (FA574) confirms a risk of an electrical short circuit occurring in the feed-through, which provides an electrically insulated path for current to flow from the electronic circuitry to the motor. This issue typically presents itself as a motor stall or low battery reset / alarm and may result in an underdose. Underdose of drug can lead to return of underlying symptoms and / or withdrawal syndrome, a life‑threatening condition for patients receiving intrathecal baclofen therapy. Detailed advice on setting / interpreting alarms and reading alarm event logs is provided in FA574.
The third FSN (FA578) has been issued to notify clinicians that the product labelling has been updated to include the advice on pocket fills, which was originally given in an earlier FSN (FA496).
The fourth FSN (FA579) confirms the recall of certain connectors manufactured before a recent design improvement. These ‘Sutureless Connector Intrathecal Catheter connectors’ may exhibit a greater potential for misalignment and subsequent occlusion, which can lead to an underdose. Full details of how to identify devices for return are provided in FA579.Note: An earlier FSN (FA535, issued in March 2012) relating to erroneous end of service messages, which can result in a drug underdose, also remains relevant as the manufacturer’s software solution has not yet been implementedAll these FSNs are available on the MHRA website.
Causa
(medtronic) 4 field safety notices concerning these products. (mda/2013/042).
Acción
Be aware that Medtronic has recently issued four Field Safety Notices concerning these products. The MHRA has summarised and prioritised the required actions below.
Ensure you follow this advice on device and patient management and, also, the return of sutureless catheter connectors to Medtronic.SynchroMed II and EL:Prime all new pumps prior to implant in the patient or connection to the catheter to reduce the risk of overdose.
Monitor all patients closely after initiation of therapy for up to 24 hours, dependent on specific drug guidelines (see FSN FA573).
Avoid the use of concomitant drugs during therapy initiation that may cause respiratory or CNS depression.
Consider providing an oral baclofen supplement to patients receiving intrathecal baclofen, until the optimal intrathecal dose is obtained.
Reinforce with patients and caregivers information on the various pump alarms (see FSN FA574) and on the signs and symptoms of withdrawal due to therapy cessation.
Continue to monitor patients for the return of baseline symptoms for the life of the implant as this could indicate pump failure due to an electrical short.
Continue to follow advice on the management of device erroneous end of service messages contained within the earlier FSN (see FSN FA535) until a software upgrade has been installed.Sutureless catheter products (used with the SynchroMed pump):
Return all sutureless connector intrathecal catheter products that have a use by date preceding 25 August 2014 (see FSN FA579).
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
In Brazil - The company informs that no card was imported until the precious moment. Only 06 units of the N Vision Clinician Model 8840 programmer were imported in August 2004 but have not yet been used as there are no 8870 software application cards available. It further informs that this recall is limited to software application cards and does not include other equipment and accessories and no action to patients on this recall is required. Clarifies that it has developed a software replacement version AAA02 that provides additional information and clarifications of the time intervals designed to assist the user in the risk of error in data entry. These software application cards were distributed from December 2002 to May 2004. As of May 2004 Medtronic Neurological no longer distributed these cards. For more information, contact Medtronic by telephone at the above number or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.
Causa
Medtronic has received overdose notifications associated with the use of the above-mentioned software cards when users mistakenly enter the periodic bolus interval value in the minutes field instead of entering them into the programmer's hours field. 4 patients with serious injuries and 2 deaths may have resulted from this problem. the manufacturer declares that this subject is limited to software cards when they are used to program synchromed and synchromed el pumps and does not include sybchromed ii pumps or any other equipment. the company has developed replacement software to reduce the risk of error in data entry. the manufacturer started a recall by letter dated august 2004 and states that half of the affected software cards were replaced in early august 2004.
Acción
Check receipt of the letter dated August 2004, two attachments and Medtronic acknowledgment form. Identify and segregate any affected product in your inventory. Remove the infusion pump scheduler application card, and identify it with the software version following the instructions in attachment 1. If you have card programmers with software in AAA version 02, proceed as follows: (1) Complete the acknowledgment form, and return it by mail to Medtronic at the address below. (2) Contact Medtronic at (800) 328-0810, ext. 88608, USA or your local Medtronic representative outside the US to notify you of the number of affected cards in your inventory and to request updated versions. (3) Upon receipt of the updated cards, return the old cards to Medtronic by mail at the address below using the shipping envelope provided. If you need to use the infusion pump programmers before completing this recall, make sure during programming that you have selected the appropriate time field when entering the duration time or the interval time following the instructions in annex 2. If you already have AAD 02 version software updated on your infusion pump scheduler, or if you no longer have any affected products in your inventory, complete the recognition form, and return it to Medtronic by mail at the address below. Re-insert the AAD 02 card application following the instructions in Appendix 1, and continue using it. For more information, contact Medtronic by telephone at the above number or your local Medtronic representative.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Medtronic Inc. recently conducted a survey of the occurrence of chronic inflammation or granuloma in the distal portion of intrathecal catheters used in implantable infusion pumps (IsoMed, SynchroMed II and SynchroMed EL), particularly in cases of use of these same pumps in opioid infusion therapies, baclofen, drug-drug compounds and other pharmacological preparations. The exact cause of inflammatory mass formation is still unknown, but the higher rate of occurrence of this problem is associated with the use of opioids, particularly when using high doses, or high concentration doses, of morphine sulfate and / or other opioids. In December 2007, the company estimated the incidence rate of inflammatory mass (from reported cases) in patients implanted and submitted to infusion of drugs for pain treatment by 0.49%, higher than the incidence rate of 0, 1% reported in 2001. Medtronic Inc.'s expectation is that the rate of reported occurrences of this problem will increase as cases of this type have occurred between 6 months and> 10 years after implantation of the infusion device in patients. The symptoms reported in patients are as follows: decreased therapeutic response / inadequate attenuation of pain, pain, neurological dysfunction, paralysis / paraplegia, muscle weakness / weakness, numbness, incontinence, motor difficulties, urinary retention, tingling sensation, and headache . The risk of this problem occurring seems to be cumulative over time and increases as higher concentrations of opioids are used in the treatment.
Causa
Possibility of inflammatory mass formation at the tip of the intrathecal catheter used in isomed and synchromed ii implantable infusion pumps.
Acción
The company that manufactures the product (Medtronic Inc. - USA) recommends that intrathecal opioids be administered in a way to provide an adequate analgesic action using the lowest doses possible. Physicians who accompany patients implanted with these infusion pumps should implant a routine of monitoring specific to the needs of each patient, aiming to identify the formation of inflammatory mass from clinical signs and symptoms presented. Special attention should be given to patients whose implant is used for infusion of drug-compound drugs, or preparations that include baclofen and opioids. The company currently in possession of the product registration in Brazil (DABASONS LTDA) informed the Anvisa's Technovigilance Unit that it has already initiated contact with its clients involved in this action, through letters of communication. According to the company, 484 units of these devices were marketed in Brazil to date, and there are also 28 non-marketed units retained in stock. The company said it had not marketed the Synchromed EL (also at risk) implantable infusion pump in Brazil. Anvisa's Technovigilance unit is following up on this case.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to Medtronic Ltd., based on data from the Medtronic Implantable Systems Performance Registry (ISPR), the overall failure rate of the SynchroMed II pump, at 78 months after implantation, is 2.4% when it is used to infuse approved drugs, and 7.0% when used to infuse non-approved drugs. The use of unapproved drugs can lead to intermittent or permanent pump motor blockages, which can be reported as a loss of or change in therapy - pumps may present motor blockages when used with approved or unapproved drugs, however, of the pump motor were reported at a significantly lower rate when only approved drugs are used (as quoted above). Additional information: Alert message published by the company at: http://portal.anvisa.gov.br/wps/wcm/connect/1a4a23004d9b08eab88ef9c116238c3b/Carta_de_Comunicacao_ao_Cliente.pdf?MOD=AJPERES. List of drugs approved for use in Synchromed pumps: http://portal.anvisa.gov.br/wps/wcm/connect/4c479d804d9b095bb897f9c116238c3b/Lista_dos_Farmacos_Aprovados.pdf?MOD=AJPERES Report on increased risk of engine crash: http: / / / / / / / #### UPDATE (03/13/2013): This field action was finalized by Medtronic Comercial Ltda on 02/02/2013 (see file 0126047 / 13-2). The company showed the sending of warning messages to customers who own the product at risk. ####
Causa
Use of non-approved drugs for synchromed infusion pumps may increase the chance of intermittent or permanent motor blockage, leading to underdosing or loss of therapy.
Acción
The company is sending an alert message ("Urgent Safety Warning - Use of Unapproved Drugs with the Synchromed Implantable Infusion Pump), with information about the problem and ways to avoid it - not using drugs that have not been approved for the product concerned.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Verify the details of the field action in the Medtronic Field Emergency Notification issued at Med.gov 08/27/2014: Field action completed by the company on 04/30/2014.
Causa
Problems in the model 8870 software application card used in 8840 n'vision ™ medical programmer may lead to the following failures in the above devices: (1) in synchromed ii deployable infusion pumps: erroneous replacement by date and early / premature reservoir alarm ; (2) in programmable neurostimulators: loss of stimulation and excessive stimulation.
Acción
Medtronic is contacting its customers to begin updating the software.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Company Information: As per the agreement published by the FDA itself (available for access at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444690.htm) on April 27, 2015, Medtronic needs to complete certain corrections and improvements to the SynchroMed pump and the Neuromodulation Quality System to comply with FDA regulations for medical devices. The decree calls for changes in product design that will include changes to address previously reported problems through medical device correction notices, which can be found at http://professional.medtronic.com/neuro/idd/ind/product- advisories. In addition, the agreement also requires Medtronic to hire the services of an independent expert to inspect the Neuromodulation Quality System and its processes and records and to obtain certification ensuring that the system complies with the requirements of the decree. Once the compliance of the Medtronic Neuromodulation Quality System has been proven to FDA satisfaction, the limitations on the manufacture and distribution of SynchroMed pumps will be terminated. Medtronic Comercial Ltda reported that it did not import the products of the Columbia Heights, Minnesota / USA plant (plant affected by consent decree), since it was not requested to certify the GMP of said plant until the present moment, and also for not be one of the manufacturers approved by ANVISA. Under this agreement with the US FDA, Medtronic may continue to manufacture and supply SynchroMed drug infusion pumps to patients who have the product implanted and in need of a replacement as well as to new patients when under conditions of medical necessity . The agreement with the FDA is specific to the SynchroMed drug infusion system and does not include any other Medtronic product or business. Anvisa emphasizes that the measures adopted in the consent decree are applicable to the US and that, in Brazil, the case is under evaluation by ANVISA. This alert will be updated as new information becomes available.
Causa
The us food and drug administration (fda) has established a consent decree with medtronic, which has established limitations on the manufacture and distribution of synchromed pumps in the usa.
Acción
The company Medtronic Comercial Ltda has forwarded information on the subject to Anvisa, which are under evaluation. There is currently no information to indicate any problem or restriction of use of SYNCHROMED pumps. Users of the product should continue their use normally, following the instructions for use of the product.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the company, the customer must "Identify SynchroMed II pumps manufactured prior to project changes through product identification number and expiration date. According to the following information: Product Identification Number for pumps manufactured before design changes: • Model 8637-20: PIN 863702007H • Model 8637-40: PIN 863704007H Any pump with an Expiration Date on or before May 14, 2017 was manufactured prior to design changes. Wait for the Medtronic Representative to contact you for equipment recovery. "
Causa
Medtronic has incorporated enhancements to the synchromed ii pump, which reduces the possibility of an internal short circuit and motor corrosion, resulting in less effective treatment. currently all synchromed ii pumps are already manufactured with these improvements. the statement is intended to inform customers that medtronic representatives will, through each customer's inventory review, retrieve any out-of-use synchromed ii pumps manufactured before design changes with the above improvements.
Acción
The company will carry out field corrections. LETTER TO THE CUSTOMERS IN ANNEX. Code FA696.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
New guidelines for priming bolus are listed below. • For a complete system bolus priming: Based on the drug's therapeutic index and patient sensitivity, some individuals may need additional monitoring until the released drug reaches the planned concentration. Do not increase the scheduled daily dose within the first 48 hours after a bolus priming as the released drug may not have reached the planned concentration during that time. • For a complete system priming bolus: Selected priming bolus parameters have been carefully selected based on extensive testing and modeling. To ensure optimal initiation of therapy, no modifications to these values are recommended. • Priming bolus function was not characterized during intravascular administration of floxuridine (FUDR) and methotrexate; therefore, dosing in the first 24 hours may be variable.
Causa
This phase ii of field action 573 is a follow up to the june 2013 notification (see attached copy of that letter for a full description of the problem and possible risks) pertaining to the priming bolus function of synchromed ii and is intended to inform you that medtronic is updating the model 8870 software application card (for version bbu01), as well as the labeling of the synchromed® infusion system to address the problem. the synchromed priming bolus function is intended to rapidly advance the drug from the pump reservoir to the tip of the catheter, allowing the initiation of therapy while the patient remains under medical supervision. the upgraded 8870 software card softens the potential for clinically relevant effects relating to unintended excessive release of the drug during the priming bolus procedure of the whole system. therapeutic applications on the software card for deep brain stimulation and spinal cord stimulation remain unchanged. this letter presents a description of the software change, description of labeling changes, recommendations for 8870 software card, and new recommendations for priming bolus.
Acción
Field Action Code FA573 Phase II triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will make correction in the field.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Medtronic does not recommend the prophylactic replacement of SynchroMed II pumps with the previous battery design because of the estimated low occurrence rate, the presence of pump alarms, and the risk associated with replacement surgery. This opinion has been reviewed and is supported by the panel of specialized external physicians. However, proper consideration should be given to the medical needs of each patient. When critical and non-critical alarms listed below occur, Medtronic strongly recommends that replacement surgery be scheduled as quickly as possible for these patients.
Causa
This notice provides an update to information previously reported to physicians in july 2011 regarding the reduced battery performance failure rate on the medtronic model 8637 synchromed® ii pump manufactured as of june 2011 (medtronic's reference: fa522). this notification reinforces previously reported patient treatment recommendations regarding this problem. this notification does not apply to currently distributed or deployed synchromed ii devices or to any device manufactured after june 2011. in latin america, medtronic began distributing the synchromed ii pumps with a new battery design in july 2011.
Acción
Field Action Code FA760 released under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will update, correct or supplement the instructions for use.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
There are no additional recommendations. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/11/2017 - Date of notification notice for Anvisa: 11/17/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
Causa
The purpose of this letter is to inform you that medtronic has received approval to implement a design change in the synchromed® ii implantable drug infusion pump, which reduces the likelihood of engine shut down, which may result in loss of therapy. for pumps manufactured prior to this design change, an analysis of our post-marketing data estimates that the pump's ability to survive specific non-recoverable engine shutdown at 6 years post-implant is 97.3% for pumps exposed to the indication of the label and 91.1% 2 for pumps exposed to medicinal products outside the indication of the label. the most common contributing factor for engine shutdown is axle wear, and this condition is observed in 59% of synchromed ii pumps returned and analyzed for engine shutdown. engineering tests estimate that this new design change covers more than 99% of shaft wear, and will reduce the occurrence of engine shutdown.
Acción
Field Action Code FA794 Phase I triggered under the responsibility of the company Medtronic Comercial Ltda. It will notify the customers of the design change.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Medtronic safety note (FA794) on implantable SynchroMed II infusion pumps