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.
SC Catheter and Revision Kit Models: 8709SC, 8731SC, 8596SC, 8578
IsoMed® Pump Model: 8472
This physician communication provides important safety information regarding Medtronic Sutureless Connector (SC) intrathecal catheters and revision kits (hereafter referred to as “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.
Read on for detailed information related to this communication.
This Dear Healthcare Professional letter provides information regarding the issue, along with patient management recommendations.
This document provides catheter replacement information (US patients only).
This document provides unreimbursed expense information (US patients only).
Models Affected:
8637-20, 8637-40
This physician 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.
Read on for detailed information related to this communication.
This Dear Healthcare Professional letter provides information regarding the issue, along with patient management recommendations.
This Dear Healthcare Professional letter enclosure 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.
This Dear Healthcare Professional letter enclosure contains information on failure rates for pumps within the affected time period.
This Dear Healthcare Professional letter enclosure contains a description of how alarms are accessed through the N’Vision 8840 clinician programmer.
This Dear Healthcare Professional letter enclosure is the currently approved Emergency Procedure Sheet (UC200303503a EN NP5676a EN PN221500-101). It provides patient management recommendations associated with baclofen withdrawal.
This Dear Healthcare Professional letter enclosure is a sample patient letter that a physician may use as necessary to communicate with their patients on this issue.
This link leads to a web-based tool that can be used to identify whether a specific pump serial number falls within the affected population of devices.
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:
Read on for detailed information related to this communication.
This Dear Healthcare Professional letter provides information regarding the new information, along with patient management recommendations.
This document provides a summary of the new information related to potential effects of an MRI scan on the SynchroMed pump.
This document provides guidance on when to interrogate a pump subsequent to an MRI.
This document provides guidance on how to perform a pump roller study procedure on the SynchroMed EL pump.
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.
This Dear Healthcare Professional letter provides information regarding the issues, along with implant recommendations related to connecting the SC Catheter to the infusion pump.
This document provides detailed information on connecting the catheter to the pump and verifying proper attachment.
This document provides detailed information on performing a catheter contrast study.
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.
This Dear Healthcare Professional letter provides information regarding the issue, along with identification procedures and patient management recommendations.
This Dear Inventory/Risk Manager letter provides recall instruction for non-implanted devices that are potentially affected based on device serial number.
This document provides detailed information about the missing propellant condition, along with underdose and overdose scenarios.
This document provides steps for identifying a pump that is missing propellant.
This document provides reimbursement information (relevant to USA only)
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.
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
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.
| Product: | Model 8637 SynchroMed II Implantable Infusion Pump, Model 8626/8627 SynchroMed EL Implantable Infusion Pump, Model 8616/8617 SynchroMed Implantable Pump, and Model 8472 IsoMed® Implantable Pump |
| Therapy: | All indications, including ITB Therapy |
| Date of Communication: January 2008 | |
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 TherapySM (Intrathecal Baclofen Therapy) can be fatal if not treated promptly and effectively.
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.
| Product: | Model 8626/8627 SynchroMed EL Implantable Infusion Pumps |
| Therapy: | All indications, including ITB Therapy |
| Date of Communication: August 2007 | |
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.
| Product: | Model 8637 SynchroMed II Implantable Infusion Pump, Model 8626/8627 SynchroMed EL Implantable Infusion Pump, Model 8616/8617 SynchroMed Implantable Pump, and Model 8472 IsoMed® Implantable Pump |
| Therapy: | Intrathecal infusion therapy for pain, not including ITB Therapy |
| Date of Communication: November 2006 | |
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.
| Product: | Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit |
| Therapy: | All indications, including ITB Therapy |
| Date of Communication: July 2006 | |
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.
| Product: | Model 8627 SynchroMed EL Implantable Infusion Pumps |
| Therapy: | All indications, including ITB Therapy |
| Date of Communication: May 2006 | |
The purpose of this Educational Brief is to reiterate information about Drug Formulations that:
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.
| Product: | Model 8637 SynchroMed II Implantable Infusion Pump, Model 8626/8627 SynchroMed EL Implantable Infusion Pump, Model 8616/8617 SynchroMed Implantable Pump, and Model 8472 IsoMed Implantable Pump |
| Therapy: | All indications, including ITB Therapy |
| Date of Communication: January 2006 | |