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 letter provides 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 that will be added to our product labeling. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum.
Acción
The firm, Medtronic, sent an "Urgent Medical Device Correction Cover " letter dated January 2011 to all customers. Enclosed with each letter, an "Urgent Medical Device Correction Important Clinical Information about Pocket Fills" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help perform a successful refill; be aware that the pump refill difficulty may increase due to a variety of factors (listed); monitor the patient closely for signs and symptoms of overdose according to the provided instructions. Note: Medtronic is in the process of supplementing the labeling related to improper injection with the information included in this communication.
Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT.
UPDATE - June 2013 - Medtronic Field Representative began notifying Healthcare Professionals June 3,2013,via visit to deliver and discuss the Pump Refill Procedure Safety Update letter. The letter informs clinicians that SynchroMed Implantable Infusion System labeling and the Clinician Refill Reference Card have been updated. The labeling and reference card were updated to provide important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure. The Medtronic Rep will complete a Physician Notification Confirmation form documenting the delivery of the information. A copy of the recall notification letter a
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 letter provides 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 that will be added to our product labeling. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum.
Acción
The firm, Medtronic, sent an "Urgent Medical Device Correction Cover " letter dated January 2011 to all customers. Enclosed with each letter, an "Urgent Medical Device Correction Important Clinical Information about Pocket Fills" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help perform a successful refill; be aware that the pump refill difficulty may increase due to a variety of factors (listed); monitor the patient closely for signs and symptoms of overdose according to the provided instructions. Note: Medtronic is in the process of supplementing the labeling related to improper injection with the information included in this communication.
Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT.
UPDATE - June 2013 - Medtronic Field Representative began notifying Healthcare Professionals June 3,2013,via visit to deliver and discuss the Pump Refill Procedure Safety Update letter. The letter informs clinicians that SynchroMed Implantable Infusion System labeling and the Clinician Refill Reference Card have been updated. The labeling and reference card were updated to provide important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure. The Medtronic Rep will complete a Physician Notification Confirmation form documenting the delivery of the information. A copy of the recall notification letter a
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 letter provides 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 that will be added to our product labeling. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum.
Acción
The firm, Medtronic, sent an "Urgent Medical Device Correction Cover " letter dated January 2011 to all customers. Enclosed with each letter, an "Urgent Medical Device Correction Important Clinical Information about Pocket Fills" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help perform a successful refill; be aware that the pump refill difficulty may increase due to a variety of factors (listed); monitor the patient closely for signs and symptoms of overdose according to the provided instructions. Note: Medtronic is in the process of supplementing the labeling related to improper injection with the information included in this communication.
Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT.
UPDATE - June 2013 - Medtronic Field Representative began notifying Healthcare Professionals June 3,2013,via visit to deliver and discuss the Pump Refill Procedure Safety Update letter. The letter informs clinicians that SynchroMed Implantable Infusion System labeling and the Clinician Refill Reference Card have been updated. The labeling and reference card were updated to provide important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure. The Medtronic Rep will complete a Physician Notification Confirmation form documenting the delivery of the information. A copy of the recall notification letter a
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 following up to a may 2013 communication regarding the priming bolus function for the synchromed infusion system. medtronic is updating the model 8870 software application card (to version aau01) and the synchromed pump labeling to address the priming bolus issue.
Acción
Medtronic Representatives began visiting consignees on 10/3/2016 to replace previous version Model 8870 software application cards, contained within the model 8840 NVision Clinician Programmer, with the updated version (new version is AAU01).
Beginning October 20, 2016, Implanting and Following physicians were sent an Urgent Medical Device Correction letter dated September 2016, . This letter to physicians is informing them of the updated Model 8870 software application card, and changes to SynchroMed infusion system labeling. A response form is requested to be returned to Medtronic.
Customers with questions were instructed to contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notas adicionales en la data
Causa
Four communications to help identify and manage issues that may impact the safe delivery of therapy using the synchromed® ii and synchromed el implantable drug pumps.
Acción
The IMB recommends that:
1. Relevant personnel in your organisation are made aware of these potential issues.
2. The device and patient management advice outlined in the Medtronic Communications is followed.
3. Unused sutureless connector catheters with a used by date prior to 25th August 2014 should be returned to Medtronic.
4. This IMB Safety Notice and the attached Field Safety Notices are passed on to any organisation or end user where the potentially affected devices have been transferred.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
Notas adicionales en la data
Causa
Medtronic has detected an upward shift in reports of occurrence for overinfusion associated with the 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.
Acción
The IMB recommends that:
1. Relevant personnel in your organisation are made aware of these potential issues.
2. The device and patient management advice outlined in the Medtronic Communications is considered and followed as appropriate.
3. This IMB Safety Notice and the attached FSN are passed on to any organisation or end user where the potentially affected devices have been transferred.
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 .
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
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
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
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
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
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 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.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
The manufacturer is reinforcing that the use of unapproved drug formulations can increase the risk of pump motor stall due to corrosion in the synchromed infusion systems. use of unapproved drugs or fluids can result in increased risks to the patient and permanent damage to the pump.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
This is a follow up to the may 2013 communication regarding the synchromed ii priming bolus function to inform you that the manufacturer is updating the model 8870 software application card (to version bbu01) as well as the synchromed® infusion system labeling to address the issue. 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.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
Notas adicionales en la data
Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
Causa
In july 2011, the manufacturer issued a notification regarding the potential for sudden loss of therapy due to reduced battery performanc in a small percentage of synchromed ii pumps. note: affected pumps were manufactured through june 2011; therefore, at this time all affected devices have been implanted at least 5 years.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a recall made by Medtronic. The users concerned received the attached mail (23/04/2015) (253 KB). This safety action is registered with the ANSM under the number 201504923 .. You will have the possibility of consulting its progress report on the Directory of the reports of materialovigilanc. by entering this registration number.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a withdrawal of products by the company MEDTRONIC INC .. The users concerned have received the attached mail (16/03/2016) (253 KB). This safety action is registered with the ANSM under the number 201603222. You will be able to consult its progress on the Directory of the signaling of materialovigilanc. by entering this registration number.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
In agreement with Afssaps and following the discovery of a manufacturing defect on certain devices, the company MEDTRONIC proceeded on June 5, 2008, at the recall of implantable pump lots Synchromed models 8637-20 and 8637-40 not still implanted mentioned in the attached mail and has issued recommendations for the management of patients already implanted by these lots. The implant doctors of these pumps, the directors and local correspondents of materiovigilance of the health establishments concerned in France received the mail of recommendations attached (05/06/2008) (269 ko). The directors and local correspondents of materiovigilance of the health establishments concerned in France have received the attached recall (05/06/2008) (33 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
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 received a complaint that there was an error code
displayed on the programmer when the physician attempted
to interrogate an implanted synchromed ii pump. the error
code prevented the physician from updating the pump;
however the pump was providing therapy.
Acción
A Medtronic representative visited the clinic on 2/9/2017 and corrected the SynchroMed II pump by resetting the pump memory using a SynchroMed Lab Programmer running on a Medtronic laptop with a validated protocol.
Consignee was given a Medtronic "Urgent Medical Device Correction" letter dated February 8, 2017. The letter described the Issue and Actions to be taken by the consignee. For questions contact your Medtronic Representative Medtronic or 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.
Notas adicionales en la data
Pump, Infusion - Product Code FRN
Causa
The opposite version serial numbers were assigned to 20ml and 40ml synchromed ii model 8637 pumps. this size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 ml pump and could cause some confusion related to the size of a 20 ml pump which identifies itself as a 40 ml pump.
Acción
The physicians have been notified via letter of the problem with the pump. Appointments will be made with the patients and a Medtronic representative to correct the implanted 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.
With the model 8870 software application card versions aaa 02, bbb 04, bbc 02, and bbd 01, which is used in conjunction with the model 8840 n'vision clinician programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. this issue is limited to programming the synchromed and synchromed el pumps.
Acción
Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.