Potential for Reduced Battery Performance Behind Recall of Medtronic Model 8637 SynchroMedII Implantable Fusion Pump

Medwatch, the Food and Drug Administration’s Safety Information and Adverse Event Reporting Program, notified healthcare professionals this week about a Class I recall of the SynchroMed Infusion System. Medtronic and FDA announced the recall.

According to Medtronic’s analysis, the problem 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. The recall includes the SynchroMed II Implatable Fusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.

The SychroMed II Implantable Programmable Drug Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. 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.

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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s Medwatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online at: www.fda.gov/MedWatch/report.htm.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including link to the Class I Recall Notice.


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