Product Advisories

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.

Medical Device Correction - August 2008
Important Information on Potential MRI Effects

Models Affected:
8626, 8627, 8637

This physician 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). 

Read on for detailed information related to this communication.

Medical Device Correction (PDF)
This Dear Healthcare Professional letter provides information regarding the new information, along with patient management recommendations.

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.

Post MRI Interrogation Guidelines (PDF)
This document provides guidance on when to interrogate a pump subsequent to an MRI.

Roller Study Procedure (PDF)
This document provides guidance on how to perform a pump roller study procedure on the SynchroMed EL pump.

Medical Device Safety Alert - June 2008
Proper Connection of Sutureless Connector Intrathecal Catheters

Models Affected:
8709SC, 8731SC, 8596SC, 8578

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.

Read on for detailed information related to this communication.

Safety Alert (PDF)
This Dear Healthcare Professional letter provides information regarding the issues, along with implant recommendations related to connecting the SC Catheter to the infusion pump.

Recommendations for Implant Techniques (PDF)
This document provides detailed information on connecting the catheter to the pump and verifying proper attachment.

Recommendations for Patency Verification (PDF)
This document provides detailed information on performing a catheter contrast study.

Medical Device Recall - May 2008
SynchroMed® II Missing Propellant

Models Affected:
8637-20, 8637-40

This physician communication provides important safety information related to a finite number of pumps that may have been manufactured without propellant.

Pumps without propellant cannot be fully aspirated, and therefore the full volume of drug cannot be loaded into the device. A pump without propellant can initially infuse, and then stop infusing without warning or alarm.

Read on for detailed information related to this communication.

Physician Letter (PDF)
This Dear Healthcare Professional letter provides information regarding the issue, along with identification procedures and patient management recommendations.

Risk Manager Letter (PDF)
This Dear Inventory/Risk Manager letter provides recall instruction for non-implanted devices that are potentially affected based on device serial number.

Effects of Missing Propellant on the SynchroMed II Pump (PDF)
This document provides detailed information about the missing propellant condition, along with underdose and overdose scenarios.

How to Identify Pumps Without Propellant (PDF)
This document provides steps for identifying a pump that is missing propellant.

Reimbursement Information - USA (PDF)
This document provides reimbursement information (relevant to USA only)

Serial Number List for Potentially Affected Devices (PDF)
This document provides a listing of all devices that are potentially affected by the missing propellant condition. NOTE: The inclusion of a pump in this list does not mean that the pump was manufactured without propellant.

Pump Serial Number Look-up
This link leads to a web-based tool that can be used to identify whether a specific pump serial number falls within the suspect population

Updated Information — Inflammatory Mass (granuloma) At or Near the Distal Tip of Intrathecal Catheters – Medical Device Correction

Medical Device Correction – January 2008 (PDF)

This is an update to two previous communications issued by Medtronic in 2001 and 2003, and is intended to provide the medical community with the current post-market incidence of reported inflammatory mass and information that may facilitate patient management.

References

SynchroMed^® EL Pump Motor Stall Due to Gear Shaft Wear – Medical Device Correction and Patient Management Information:

Medical Device Correction – August 2007 (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. 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. Drug withdrawal from ITB Therapy^SM (Intrathecal Baclofen Therapy) can be fatal if not treated promptly and effectively.

Patient Management Information – August 2007 (PDF)

This letter provides important patient management information for individuals with the Medtronic SynchroMed EL pumps with motors manufactured beginning September 1999. The most common failure mode for the SynchroMed EL pump is pump motor stall 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.

Patient Mortality After Implant and Initiation of Intrathecal Infusion Therapy for Pain – Educational Brief:

Educational Brief – November 2006 (PDF)

The purpose of this Educational Brief 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.

Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit – World Wide Medical Device Recall:

World Wide Medical Device Recall – July 2006 (PDF)

Medtronic is conducting a voluntary recall of the Model 8731 Intrathecal Catheter and the Model 8598 Intrathecal Catheter Distal Revision Kit. Medtronic is recalling these products because the platinum-iridium tip may be dislodged by the guide wire during implantation. Dislodgement of the tip can result in the risk of infection or other potentially serious adverse health consequences.

Model 8627 SynchroMed EL – Medical Device Recall:

Medical Device Recall – May 2006 (PDF)

The purpose of this product recall is to inform you of a SynchroMed EL pump reliability concern. The Catheter Access Port (CAP) of the pump may detach from the main body of the pump reservoir and could result in drug not being delivered through the catheter. Although the chance of this happening to the pump is rather low, if it occurs, it could cause drug delivery to stop abruptly, resulting in loss of therapy, return of underlying symptoms, and symptoms of drug withdrawal which can cause death in the most severe cases.

Medtronic Neurological Drug Delivery Pumps and Drug Formulations Containing Preservatives – Educational Brief:

Educational Brief – January 2006 (PDF)

The purpose of this Educational Brief is to reiterate information about Drug Formulations that:

• May be neurotoxic for intraspinal delivery.
• May compromise the safe and effective performance of the Medtronic infusion pumps.

It is important to communicate with your drug supplier or pharmacy to ensure the intraspinal medication you prescribe is preservative free (per United States Pharmacopeia-USP) and compatible with Medtronic infusion pumps.

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