Tuesday, September 27, 2011

FDA Recalls Several Medtronic SynchroMed II Infusion Pumps

The FDA has asked for a recall of Medtronic's SynchroMed II implantable infusion pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.

From the FDA site:

Product: SynchroMed II Implantable Infusion Pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.
Medtronic has a Device Identification web pagedisclaimer icon where customers can enter the serial number for any SynchroMed II infusion pump to determine if their pump is being recalled.

Use: The SynchroMed II Implantable Programmable Drug Pump is part of the SynchroMed II Infusion system designed to contain and administer prescribed drugs to a specific site. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is indicated when patient therapy requires the chronic infusion of the drugs or fluids. This infusion pump is indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. It is also indicated for delivery of floxuridine and methotrexate for the treatment of primary or metastatic cancer.

Recalling Firm:
Medtronic, Inc – Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568

Reason for Recall:
There is a potential for reduced battery performance in the SynchroMed II infusion Pump. Medtronic’s analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. For example, patients receiving intrathecal baclofen therapy for severe spasticity are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not treated quickly and effectively.

Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.
SynchroMed II infusion pumps were recalled for the same battery issue in July 2009.