Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Medtronic is recalling the prior configuration of synchromed ii implantable drug infusion pumps, as a new configuration is available with an enhanced motor design. this recall action only relates to unimplanted devices.Medtronic has received regulatory approval for a design change to the synchromed ii implantable drug infusion pump. this design change of the motor decreases the potential for intermittent or permanent motor stall which can cause loss of therapy. all synchromed ii pumps are now being manufactured and distributed with this change.
Acción
Medtronic will liaise with hospitals to review their inventory to locate affected pumps. Medtronic will arrange return and replacement of affected pumps.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This action is a follow up to the july 2013 communication regarding the synchromed ii priming bolus function and to inform that medtronic is updating the model 8870 software application card as well as the synchromed infusion system labelling to address the issue. the software update will change the value displayed on the 8840 programmer for the synchromed ii pump tubing volume from 0.199 ml to 0.140 ml. over delivery of drug during priming bolus has the potential to lead to overdose symptoms in some patients. this software change mitigates the potential for unintended over-delivery of drug while still ensuring prompt therapy initiation. the synchromed ii infusion system manuals were updated for the priming bolus function, and new guidelines for priming have been implemented.
Acción
Doctors are advised to continue to use the current software card and its displayed tubing volume until the Medtronic Representative has exchanged the current card with the new software card (new version is BBU01). New guidelines in labelling regarding priming bolus are identified in the customer letter and the attachment provided with the letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This communication is an update to medtronic’s march 2014 notification regarding the potential for synchromed ii pump over-infusion. “over-infusion” is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. pump reservoir contents that are less than expected may indicate that the pump has over-infused. over-infusion may or may not be associated with clinically relevant symptoms. when the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms. patients may experience under-dose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an over-infusing pump. the low reservoir alarm of an over-infusing pump will not sound if the pump reservoir is prematurely depleted. the low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume remaining in the reservoir.
Acción
Medtronic is communicating the appropriate patient management recommendations and guidelines to the clinicians managing the patients implanted with the affected devices. For more details, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump . This action has been closed-out on 26/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Medtronic is updating information communicated in july 2011 (rc-2011-rn-00769-3) regarding the failure rate for reduced battery performance in medtronic model 8637 synchromed ii pumps manufactured up to june 2011. updated failure rate information due to this issue:- pumps manufactured mar 2005 through dec 2010: 0.13% cumulative probability for pump failure at 72 months after implant. this rate remains within the failure rate upper bound of 0.2% reported in 2011.- pumps manufactured from jan 2011 through jun 2011: 3.17% cumulative probability for pump failure at 72 months after implant. this failure rate exceeds the upper bound estimate of 0.2% reported in 2011. a patient with a pump exhibiting reduced battery performance may experience return of underlying symptoms and/or withdrawal symptoms. patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not promptly and effectively treated.
Acción
Medtronic is reinforcing the advice provided in 2011. Medtronic does not recommend prophylactic replacement of SynchroMed II pumps with the prior battery design (manufactured before July 2011) because of the estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery. If Low Battery Reset (critical alarm) or premature Elective Replacement Indicator (non-critical alarm) or End of Service (critical alarm) occurs, replacement surgery should be scheduled as soon as possible. Further ongoing patient management recommendations are detailed in the hazard alert communication provided to physicians. For further information, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump-0 .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Medtronic australasia pty limited is initiating a voluntary recall for a specific lot of our model 8551 refill kits. medtronic have identified that some refill kits in the affected lot may contain an extension tubing set that is occluded. healthcare professionals may be unable to aspirate or fill the synchromed pumps using one of these affected refill kits.
Acción
Medtronic is requesting their customers to identify and segregate devices from the affected lot. Return of stock will be organised by Medtronic Customer Service.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The synchromed ii pump software update will automatically correct the following two issues:1) erroneous replace by date: the updated software corrects the issue previously communicated in medtronic’s march 2012 (tga ref: rc-2012-rn-00260-3) i.E., in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement.2) premature reservoir alarm: the updated software corrects the potential for premature low and empty reservoir alarms. these premature alarms are due to an incorrect calculation within the 8840 programmer software. the majority of these alarms occur within the clinic immediately following an interrogation.
Acción
1) Medtronic does not recommend prophylactic explant of devices because these issues are addressed automatically and non-invasively with the software card update. Until the software application card is updated in the programmer:
- Clinicians may continue to use the present software card.
- Continue the normal follow up schedule, and monitor the estimated number of months until Elective Replacement Indicator (ERI).
- Follow labelled recommendations for pump replacement within 90 days of ERI declaration.
2) In the case of a low or empty reservoir alarm:
- Review the calculated residual volume displayed on the 8840 programmer to assess if the alarm is premature.
- After the software update, any previous version of the model 8870 software application card should no longer be used and can be returned to Medtronic.
For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-II-140204.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Medtronic has detected an upward shift in reports of over-infusion, defined as an infusion rate exceeding the programmed rate by more than 14.5% as described in the labelling. when over-infusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn is less than the volume expected. the device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm. over-infusion can result in a life-threatening overdose and/or drug withdrawal resulting from premature emptying of the pump. the onset of over-infusion has occurred as early as five months after implant and throughout the service life of the pump. reports indicate that once a pump has started to over-infuse, infusion rates can continue to increase, in some cases abruptly. the device does not measure actual reservoir volume and in the context of over-infusion the reservoir may empty entirely without activating an alarm.
Acción
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 recommending prophylactic replacement of pumps. Through the Hazard alert letter, Medtronic is recommending physicians on the appropriate management of patients implanted with the affected SynchroMed II pumps. Medtronic continues to investigate this issue and will be providing updates as more information becomes available. For further information, please refer to http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-140328.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The clinician refill reference card for synchromed implantable infusion systems that was originally distributed with the january 2011 safety alert (tga ref.: rc-2010-rn-01266-3) related to pocket fills has been updated to align with new product labelling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient’s subcutaneous tissue, which includes the pump pocket, instead of the pump which can lead to life-threatening symptoms, serious patient injury, or death due to overdose or underdose.
Acción
The main title of the Clinician Refill Reference Card has been updated to read Critical Actions in the Pump Refill Procedure, and the updates to the card include:
- A description of the card’s purpose regarding pocket fill
- A reminder to clinicians of the critical steps for ensuring the pump is correctly refilled
- Detail regarding proper alignment of the refill template
- Information for actions to take if a pocket fill is suspected
- Removal of the note related to glucose testing
Medtronic has updated product manuals and is in the process of deploying the updated labelling. Current labelling for product manuals can be found at www.medtronic.com/manuals.
For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus, mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period of reduced concentration of drug will occur following the priming bolus.
Acción
Through the 'Hazard Alert' letter, Medtronic is advising clinicians regarding ongoing patient management recommendations. Medtronic recommends following published guidance for managing all patients with intrathecal therapy, in addition to the following:
- Continue use of the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision.
- Monitor all patients following start or restart of intrathecal therapy. The post-procedure monitoring period will depend upon specific drug, dose administered and patient co-morbidities.
For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electronic circuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and leads to a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms.
Acción
Through the 'Hazard Alert' letter, Medtronic is advising clinicians regarding ongoing patient management recommendations. Medtronic does not recommend prophylactic replacement of SynchroMed II or SynchroMed EL pumps due to the estimated low occurrence rate, the presence of pump alarms, and the risks associated with replacement surgery. However, appropriate consideration should be given to individual patient needs.
If repeated short duration motor stalls, Low Battery Resets (with or without Safe State), or a premature Elective Replacement Indicator occur, replacement surgery should be scheduled for therapy continuation. Alternative medical management should be considered if appropriate.
For more details, please see http://www.tga.gov.au/safety/alerts-device-synchromed-130718.htm .
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.
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
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
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
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
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
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.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
This field action is a follow-up to medtronic customer notification regarding synchromedr ii model 8637. medtronic is now exchanging non-implanted synchromedr ii pumps containing the original design batteries with pumps containing the new batteries.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The investigation report (ir) for synchromed ii pump corrosion defines the problem statement as the "degradation of synchromed ii motor components due to corrosion wear and a combination of corrosion and wear can result in temporary intermittent and/or permanent motor stall." the root cause of failure is identified as the depletion of lubricant at the shaft/jewel bearing interface which initiates mechanical wear on shaft ends resulting in wear particles that can mix with the remaining lubricant creating residue. shaft wear results in temporary or permanent motor stall.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The medical device correction includes the distribution of a new 8870 software application card version bbr/01 (revision b) which provides updates to the 8840 clinician programmer used to program medtronic spinal cord stimulators deep brain stimulators and the synchromedr ii implantable infusion system. for scs and dbs therapy: the new software provides an automatic transfer of new internal device software from the 8840 to implantable and implanted devices. this change addresses loss of stimulation caused by the exception bit behavior. this behavior is also known as error code 509. in addition the notification provides information about the potential for over stimulation or stimulation in the wrong area under a specific set of conditions typically related to device recovery from an over discharge. for synchromed ii pump therapy: the update includes correction of the issue previously communicated in the march 2012 medical device correction regarding the potential for the model 8840 n'vision clinician programmer to display an erroneous replace by date (erbd) "schedule to replace pump by" (date when used with the synchromed ii pump. the updated software also corrects the potential for premature low and empty reservoir alarms with the synchromed ii pump. these premature alarms are due to an incorrect calculation within the 8840 programmer software. no changes are being made to the implantable synchromedr ii pump device as a result of this update.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
A small number of synchromed ii implantable infusion pumps may have been manufactured without propellant.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
This field action is to provide an update to important safety information and patient management recommendations related to the potential for reduced battery performance in a small percentage of synchromedr ii pumps.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
The model 8840 physician programmer may display an incorrect "schedule to replace the pump by" date for the model 8637 synchromed ii implantable drug infusion pump. in some circumstances after a pump's eri has occurred the date may be displayed as a series of question marks or as a date greater than 90 days from the eri date potentially leading to the pump reaching end of service prior to replacement. this issue may only occur if the 90days after eri notification falls on the first day of a month. it does not affect pump function or alarms. this is due to a software error specific to the model 8870 application card software for the synchromed ii pump.