The Food and Drug Administration (FDA) has recalled eight models of Medtronic’s SynchroMed implantable fusion pumps that may suddenly stop without warning and result in death. Nearly 8,000 patients are affected by the recall.

Here we go – again

Only four months after Medtronic, the Minnesota-based medical device manufacturer, recalled 235,000 of its Sprint Fidelis defibrillator wires that were linked to five deaths and many injuries; the FDA has recalled another Medtronic product – putting the company in the hot seat – yet again. This time, the recall involves Medtronic’s SynchroMed EL Implantable Infusion Pumps.

The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The device is implanted in the patient, either with or without a side catheter access port, catheters and catheter accessories.

Class I recall

The FDA has classified this as a Class I recall. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. According to a press release from the FDA:

There is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors that were manufactured before September 1999. These pumps can stall at a higher rate due to gear shaft wear. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of drug under infusion or withdrawal. Drug withdrawal from Intrathecal Baclofen (ITB) therapy (in the patient’s spine) can cause death if not treated immediately and effectively.

Affected devices

The following SynchroMed EL model numbers are part of the FDA’s Class I recall:

• 8626-10
• 8626L-10
• 8626-18
• 8626L-18
• 8627-10
• 8627L-10
• 8627-18
• 8627L-18

Medtronic has stated that it warned doctors about the problem in August of 2007 and advised them to closely monitor patients. This version of the product is no longer used in the United States. However, news reports have stated that over 50,000 patients still have the pump implanted.

Additional information

Patients may obtain additional information from the company at:

Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis, Minnesota 55440-1250
www.medtronic.com
1-800-510-6735
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