Medtronic is committed to providing you with the highest quality products and services and ongoing support.
As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.
- November 2019 - Safety Notification: Discontinuation of the IsoMed Accessory Kits: Models 8553/8555 Refill Kit and Model 8543 Catheter Access Port (CAP) Kit
- October 2019 - Updated December 2019- Urgent: Medical Device Recall Notification - Retrieval of Specific Serial Numbers of SynchroMed II Implantable Drug Infusion Pumps
- August 2017 - Medical Device Safety Notification — SynchroMed II Implantable Drug Infusion Pump Design Change
- April 2017 - Urgent: Medical Device Correction Update - Battery Performance of the Model 8637 SynchroMed® II Implantable Drug Infusion Pump - Update to 2011 Notification
- September 2016 - Update to Model 8870 Software Application Card Used in the 8840 N'Vision Clinician Programmer and SynchroMedTM Infusion System Labeling for Priming Bolus
- September 2016 - Update to the March 2014 Communication on SynchroMed II Overinfusion
- April 2015 - SynchroMed II Implantable Drug Infusion Pump Audible Alarm
- March 2014 - SynchroMed II Implantable Drug Infusion Pump Overinfusion
- September 2013 - Model 8870 Software Application Card used in the 8840 N'Vision Clinician Programmer
- May 2013 - SynchroMed Implantable Infusion Pump Internal Shorting
- May 2013 - SynchroMed Implantable Infusion Pump Priming Bolus
- May 2013 - Update to the January 2011 Medical Device Correction letter titled "Important Clinical Information about Pocket Fills"
- May 2013 - Sutureless Connector Intrathecal Catheter Products
- November 2012 - Use of Unapproved Drugs with the SynchroMed Implantable Infusion Pump
- July 2011 - Urgent: Medical Device Correction - July 2011
Model 8637 SynchroMed II Battery Performance - January 2011 - Important Clinical Information about Pocket Fills: SynchroMed II and SynchroMed EL Implantable Drug Infusion Systems
- September 2010 - Model 8731SC Intrathecal Catheter Kit and Model 8598A Spinal Segment Revision Kit Potential Endotoxin Issue
- August 2010 - Cephalad Migration of Catheter Fragments
- August 2009 - Sutureless Connector (SC) Intrathecal Catheters Are Not Compatible with IsoMed Constant–Flow Infusion Pumps
- July 2009 - Model 8637 SynchroMed II Battery Performance
- August 2008 - Important Information on Potential MRI Effects
- June 2008 - Proper Connection of Sutureless Connector Intrathecal Catheters
- January 2008 - Inflammatory Mass (Granuloma) at or Near the Distal Tip of Intrathecal Catheters
- August 2007 - SynchroMed EL Pump Motor Stall Due to Gear Shaft Wear
- November 2006 - Patient Mortality after Implant and Initiation of Intrathecal Infusion Therapy for Pain
2019
Safety Notification: Discontinuation of the IsoMed Accessory KitS: Models 8553/8555 Refill Kit and Model 8543 Catheter Access Port (CAP) Kit
Models Affected:
IsoMed Models 8553/8555 Refill Kit and Model 8543 Catheter Access Port (CAP) Kit
Description:
Medtronic is voluntarily issuing a safety notification related to availability of the IsoMed Catheter Access Port (CAP) and Refill Kits. It is intended for those who have purchased at least one of the IsoMed Accessory Kits in the past 3 years.
Refer to the customer letter for details regarding this communication.
Urgent: Medical Device Recall Notification - Retrieval of specific serial numbers of SynchroMed II Implantable Drug Infusion Pumps (Updated December 2019)
Models Affected:
8637-20, 8637-40
Description:
Medtronic is voluntarily retrieving specific SynchroMed™ II implantable drug infusion pumps, models 8637-20 and 8637-40, after investigating complaints related to permanent motor stall due to the potential for the presence of a foreign particle inside the pump motor assembly. The source of the foreign particle has been identified and eliminated. The SynchroMed II pumps that are affected and in scope of this recall can be identified by the serial number and date of manufacture, which ranges from 04 May 2018 through 05 April 2019, however not all serial numbers within this date range are affected.
December 2019 Update
Based on feedback from customers and regulators in November 2019, an additional communication will be sent to active managing and implanting Healthcare Professionals (HCPs) to inform them of the potential for the presence of a foreign particle inside the pump motor assembly. HCPs with patients implanted with a potentially impacted pump will be asked to confirm receipt of the HCP Notification Letter by returning the HCP Confirmation Form.
HCPs that do not have patients implanted with a pump in scope of this recall will receive the HCP Notification Letter and a Cover Letter informing them that they are not affected by this recall. No further action is required for this consignee population.
Refer to HCP letter for details regarding this communication.
2017
MEDICAL DEVICE SAFETY NOTIFICATION — AUGUST 2017 SYNCHROMED II IMPLANTABLE DRUG INFUSION PUMP DESIGN CHANGE
Models Affected:
8637-20, 8637-40
Description:
This notification provides information regarding a design change to the SynchroMed II implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy.
Refer to the customer letter for details regarding this communication.
Urgent: Medical Device Correction Update - April 2017 Battery Performance of the Model 8637 SynchroMed® II Implantable Drug Infusion Pump
Update to the 2011 Notification
Models Affected:
8637-20, 8637-40
Description:
This clinician communication provides an update to information previously communicated to physicians in July 2011 regarding the failure rate for reduced battery performance in Medtronic Model 8637 SynchroMed® II pumps manufactured through June 2011. This notice reinforces previously communicated patient management recommendations related to this issue.
Reduced battery performance impacts battery voltage, which can prematurely activate the pump Elective Replacement Indicator (ERI), End of Service (EOS), and/or cause a Low Battery Reset.
SynchroMed II Serial Number Lookup
This link leads to a web-based tool that can be used to determine the pump manufacture timeframe based on pump serial number.
2016
URGENT: MEDICAL DEVICE CORRECTION – SEPTEMBER 2016
UPDATE TO MODEL 8870 SOFTWARE APPLICATION CARD USED IN THE 8840 N’VISION CLINICIAN PROGRAMMER AND SYNCHROMEDTM INFUSION SYSTEM LABELING FOR PRIMING BOLUS
Models Affected:
8637-20, 8637-40 SynchroMed Infusion System
8840 Clinician Programmer
8870 Software Application Card
Description:
This notification is a follow up to the May 2013 communication regarding the SynchroMed II priming bolus function. Medtronic is updating the Model 8870 software application card as well as the SynchroMed Infusion System labeling to mitigate the risk of the potential for clinically relevant effects of over-delivery of unintended drug during the full system priming bolus procedure. 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. Read on for detailed information related to this communication.
URGENT: MEDICAL DEVICE CORRECTION UPDATE– SEPTEMBER 2016
UPDATE TO THE MARCH 2014 COMMUNICATION ON SYNCHROMED II OVERINFUSION
Models Affected:
8637-20, 8637-40 SynchroMed II Implantable Drug Infusion Pump
Description:
This communication is an update to Medtronic's March 2014 notification regarding the potential for SynchroMed II pump overinfusion. This notification updates information related to contributing causes, occurrence rate and patient management recommendations. Consistent with the previous communication, Medtronic is not retrieving SynchroMed II pumps from the field or recommending prophylactic replacement of the pumps.
2015
Urgent Medical Device Correction – April 2015
SynchroMed II Implantable Drug Infusion Pump Audible Alarm
Models Affected:
8637-20, 8637-40
This physician communication provides important information regarding a potential malfunction of the audible alarm of a finite subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps (based on serial number). The cause of this issue has been addressed, and therefore only products identified by this notification are potentially affected. Medtronic is not recommending prophylactic replacement of pumps due to the low projected rate of occurrence of this issue.
This communication is based on information available to date and was developed in collaboration with clinical experts. Read on for detailed information related to this communication.
synchromed2alarm.medtronic.com
This web-based tool can be used to identify whether a specific SynchroMed II pump is potentially affected by this audible alarm issue based on pump serial number.
2014
Urgent: Medical Device Correction – March 2014
SynchroMed II Implantable Drug Infusion Pump Overinfusion
Models Affected:
8637-20, 8637-40
This physician communication provides important new information regarding 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. 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. This communication is based on information available to date and was developed in collaboration with clinical experts. Read on for detailed information related to this communication.
2013
Urgent: Medical Device Correction – September 2013
Model 8870 Software Application Card used in the 8840 N'VisionTM Clinician Programmer
This notification is associated with SynchroMed drug infusion therapy and provides information on two issues with the Model 8840 N'Vision Clinician Programmer that are being corrected by a software update. Read on for detailed information.
Urgent: Medical Device Removal – May 2013 Sutureless Connector Intrathecal Catheter Products
Affected Products:
Models: 8709SC, 8731SC, 8596SC, 8578 (with Use by Date prior to 25 Aug 2014)
The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing unused products from the market that were manufactured with the previous design, and recommends the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.
Refer to the customer letter for details regarding this Urgent Medical Device Removal.
2012
Medical Device Safety Notification – November 2012
Use of Unapproved Drugs with the SynchroMed Implantable Infusion Pump
Affected Products:
SynchroMed II and SynchroMed EL
This clinician communication provides updated information on Medtronic Neuromodulation's continuing efforts to investigate and communicate the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with the SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.
Read on for detailed information related to this communication.
2011
Urgent: Medical Device Correction - July 2011
Model 8637 SynchroMed II Battery Performance
Update to the 2009 Communication
Models Affected:
8637-20, 8637-40
This clinician communication provides updated information regarding the scope and occurrence of the SynchroMed II Battery Performance issue that was previously communicated in July 2009.
Reduced battery performance impacts battery voltage, which can prematurely activate the pump Elective Replacement Indicator (ERI), End of Service (EOS), and/or cause a Low Battery Reset.
Read on for detailed information related to this communication.
Pump Serial Number Look-up
This link leads to a web-based tool that can be used to determine the battery manufacture timeframe based on pump serial number.
Urgent: Medical Device Correction – January 2011
Important Clinical Information about Pocket Fills: SynchroMed II and SynchroMed EL Implantable Drug Infusion Systems
This communication provides important reminders concerning the potential for a pocket fill during a SynchroMed II or EL implantable drug infusion system procedure and important patient management recommendations.
Note: Refer to the 2013 Product Advisory listing for an update to this communication.
Clinician Refill Reference Guide
This reference guide supplements SynchroMed Implantable Infusion Pump refill kit labeling and provides ways to assess the needle position throughout a pump refill procedure. This document has been updated. Refer to the 2013 Pump Refill Procedure Safety Update for the updated Clinician Refill Reference Card.
2010
Medical Device Recall – September 2010
Model 8731SC Intrathecal Catheter Kit and Model 8598A Spinal Segment Revision Kit Potential Endotoxin Issue
This communication provides information and instructions regarding the recall of specific lots of Medtronic intrathecal catheter kits and revision kits. Medtronic is performing this recall because of the potential for a component within these kits to exceed USP requirement for bacterial endotoxin.
2009
Medical Device Correction – August 2009
Sutureless Connector (SC) Intrathecal Catheters Are Not Compatible with IsoMed Constant–Flow Infusion Pumps
This communication provides important safety information regarding Medtronic Sutureless Connector (SC) intrathecal catheters and revision kits (SC catheters).
The current SC catheter labeling incorrectly states that SC catheters are compatible with Medtronic IsoMed constant-flow infusion pumps. SC catheters are not compatible with IsoMed pumps.
SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps.
Medical Device Correction - July 2009
Model 8637 SynchroMed II Battery Performance
This communication provides important safety information related to a finite number of pumps that may experience reduced battery performance.
Reduced battery performance impacts battery voltage, which can prematurely activate the pump Elective Replacement Indicator (ERI), End of Service (EOS), and/or cause a Low Battery Reset.
2008
Medical Device Correction - August 2008
Important Information on Potential MRI Effects
This communication provides new safety information related to MRI (magnetic resonance imaging) effects that may impact pump performance. As stated in the product labeling for all SynchroMed pumps, the magnetic field of an MRI scan will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of MRI exposure.
The pump should resume normal operation when removed from the MRI magnetic field; however, the following is new information:
- There is the potential for a delay in the return of proper drug infusion after an MRI scan (this affects all SynchroMed pumps).
- There is the potential for a delay in the logging of motor stall events after an MRI scan (this only affects SynchroMed II pumps).
Medical Device Safety Alert - June 2008
Proper Connection of Sutureless Connector Intrathecal Catheters
This safety alert provides important safety information concerning potential disconnection of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump. Please note that this issue does not involve Medtronic MiniMed insulin pumps.
Medtronic has received reports of infusion system difficulties that have been attributed to occlusion between the sutureless pump connector and the catheter port, and disconnections of the sutureless pump connector from the catheter port. Medtronic investigation indicates these events are caused by misalignment or incomplete connection of the sutureless pump connector to the catheter port. Proper alignment and full engagement of the sutureless pump connector to the catheter port during attachment is critical in ensuring the catheter is properly and completely connected to the pump.
2007
Medical Device Correction – August 2007
SynchroMed EL Pump Motor Stall Due to Gear Shaft Wear
This communication provides important information about a pump motor stall issue that affects SynchroMed EL pumps with motors manufactured prior to September 1999. This population of pumps can stall at a higher rate due to gear shaft wear.
If a pump motor stall occurs, drug delivery will stop abruptly and without warning resulting in loss of therapy, return of underlying symptoms, and/or symptoms of drug underinfusion or withdrawal. The SynchroMed EL pump does not provide an alarm to alert the patient or clinician to a stalled motor condition. Drug withdrawal from ITB Therapy can be fatal if not treated promptly and effectively.
2006
Educational Brief – November 2006
Patient Mortality after Implant and Initiation of Intrathecal Infusion Therapy for Pain
The purpose of this communication is to provide information for reducing the risk of death or serious injury after initiation of intrathecal infusion therapy for pain. Medtronic has received reports of patient deaths occurring soon after the implant or revision of a SynchroMed system. The available evidence indicates the infusion systems operated normally and device malfunction was not the cause of these adverse events.