PRODUCT ADVISORIES INTRATHECAL BACLOFEN THERAPY WITH LIORESAL INTRATHECAL (BACLOFEN INJECTION)

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.


2016

URGENT: MEDICAL DEVICE CORRECTION – SEPTEMBER 2016

UPDATE TO MODEL 8870 SOFTWARE APPLICATION CARD USED IN THE 8840 N’VISION CLINICIAN PROGRAMMER AND SYNCHROMED™ 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.

pdf Healthcare Professional Letter (.pdf)

This letter provides information regarding the issue, along with patient management recommendations.

121KB

pdf Instructions to Initiate an Alarm Test on the 8840 Clinician Programmer (.pdf)

These instructions explain the steps required to initiate an alarm test using the 8840 Clinician Programmer during a patient visit.

141KB

pdf Instructions to Review Event Logs on the 8840 Clinician Programmer (.pdf)

These instructions explain the steps required to review event logs using the 8840 Clinician Programmer after interrogating the pump.

140KB

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'Vision 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 Correction – May 2013

SynchroMed Implantable Infusion Pump Internal Shorting

Affected Products:
SynchroMed II and SynchroMed EL

Read on for detailed information related to this communication.

pdf Healthcare Professional Letter (.pdf)

This letter provides important safety information related to the potential for electrical shorting internal to the SynchroMed infusion pump.

515KB

Urgent: Medical Device Correction – May 2013

SynchroMed Implantable Infusion Pump Priming Bolus

Affected Products:
SynchroMed II and SynchroMed EL

Read on for detailed information related to this communication.

pdf Healthcare Professional Letter (.pdf)

This letter provides important safety information regarding unintended delivery of drug during the priming bolus function.

278KB

Pump Refill Procedure Safety Update – May 2013

Update to the January 2011 Medical Device Correction letter titled "Important Clinical Information about Pocket Fills"

Affected Products:
SynchroMed II and SynchroMed EL

Read on for detailed information related to this communication.

pdf Healthcare Professional Letter (.pdf)

This letter provides updated information regarding the Clinician Refill Reference card that was originally distributed with the January 2011 Medical Device Correction related to pocket fills.

163KB

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.

pdf Healthcare Professional Letter (.pdf)

This letter provides information for healthcare professionals who implant and manage patients with the SynchroMed II or SynchroMed EL drug infusion system.

41KB

pdf Increased Risk of Motor Stall and Loss of or Change in Therapy with Unapproved Drug Formulations (.pdf)

This document provides additional details related to Medtronic Neuromodulation’s investigation into motor gear corrosion.

97KB

pdf Summary of Approved Drugs (.pdf)

This document summarizes drug details from the SynchroMed pump labeling.

132KB


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 previouly 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.

pdf Physician Letter with Enclosures (.pdf)

This letter provides information regarding the issue, along with patient management recommendations.

796KB

pdf New Battery Availability Notification (.pdf)

This letter contains information regarding the availability of the SynchroMed II pump with the new battery design.

105KB

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.

pdf Healthcare Professional Letter (.pdf)

This letter provides information regarding this issue for healthcare professionals who implant and manage patients with SynchroMed II and EL Drug Infusion Systems.

34KB

pdf Patient Appointment Card - Morphine (.pdf)

A wallet-sized information card that can be used to remind patients receiving Morphine of their appointment information, drug information, and drug overdose symptoms.

704KB

pdf Patient Appointment Card - Prialt (.pdf)

A wallet-sized information card that can be used to remind patients receiving Prialt® of their appointment information and drug information, and drug overdose symptoms.

730KB

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 communcation 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.

pdf Inventory/Risk Manager Letter (.pdf)

This letter provides information and instructions regarding the endotoxin issue recall.

99KB

pdf Healthcare Professional Letter (.pdf)

This letter provides information regarding this issue for healthcare professionals who have used affected product.

81KB

Medical Device Correction – August 2010

Cephalad Migration of Catheter Fragments

pdf Healthcare Professional Letter (.pdf)

This letter provides information regarding the potential for cephalad migration of catheter fragments in patients who have received intrathecal drug infusion therapy.

24KB


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.

pdf Healthcare Professional Letter (.pdf)

This letter provides information regarding the issue, along with patient management recommendations.

102KB

pdf Warranty and Replacement Information (.pdf)

This document provides catheter replacement information (US patients only).

21KB

pdf Unreimbursed Expense Information (.pdf)

This document provides unreimbursed expense information (US patients only).

20KB

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.

pdf Healthcare Professional Letter (.pdf)

This letter provides information regarding the issue, along with patient management recommendations.

106KB

pdf Pump Event Information (.pdf)

This letter contains descriptions of the events that can be triggered by the reduced battery performance issue. Additionally, it describes how the Model 8840 N’Vision programmer displays these events.

95KB

pdf Pump Survival (.pdf)

This letter contains information on failure rates for pumps within the affected time period.

29KB

pdf Alarm Information Sheet (.pdf)

This letter contains a description of how alarms are accessed through the N’Vision 8840 Clinician Programmer.

33KB

pdf Warranty and Replacement Cost Information (.pdf)

This letter is a sample patient letter that a clinician may use as necessary to communicate with their patients on this issue.

53KB


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).
pdf Medical Device Correction (.pdf)

This letter provides information regarding the new information, along with patient management recommendations.

387KB

pdf New Information Regarding Potential MRI Effects (.pdf)

This document provides a summary of the new information related to potential effects of an MRI scan on the SynchroMed pump.

38KB

pdf Post MRI Interrogation Guidelines (.pdf)

This document provides guidance on when to interrogate a pump subsequent to an MRI.

99KB

pdf Roller Study Procedure (.pdf)

This document provides guidance on how to perform a pump roller study procedure on the SynchroMed EL pump.

294KB

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.

pdf Safety Alert (.pdf)

This letter provides information regarding the issues, along with implant recommendations related to connecting the SC Catheter to the infusion pump.

78KB

pdf Recommendations for Implant Techniques (.pdf)

This document provides detailed information on connecting the catheter to the pump and verifying proper attachment.

141KB

pdf Recommendations for Patency Verification (.pdf)

This document provides detailed information on performing a catheter contrast study.

79KB

Medical Device Correction — January 2008

Inflammatory Mass (Granuloma) at or Near the Distal Tip of Intrathecal Catheters

This is an update to two previous communications issued by Medtronic in 2001 and 2003.

pdf Medical Device Correction (.pdf)

This update is intended to the current post-market incidence of reported inflammatory mass and information that may facilitate patient management.

66KB


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.

pdf Medical Device Correction (.pdf)

This letter is to inform you of a potential pump motor stall issue that affects SynchroMed EL pumps with motors manufactured prior to September 1999.

478KB

pdf Patient Management Information (.pdf)

This letter provides important patient management information for individuals with the Medtronic SynchroMed EL pumps with motors manufactured beginning September 1999.

492KB


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.

pdf Educational Brief (.pdf)

This educational brief provides important pain therapy information for clinicians who implant and/or manage patients with a SynchroMed or IsoMed infusion system.

130KB