Medtronic Issues Class I Recall for SynchroMed El Implantable Infusion PumpsFeb 4, 2008 | Parker Waichman LLP
Medtronic Inc. SynchroMed El Implantable Infusion Pumps were the subject of a Class I Food & Drug Administration (FDA) recall last August. According to the FDA recall notice posted on the agency’s website today, the Medtronic SynchroMed El Implantable Infusion Pumps stall at an unusually high rate, putting patients at risk of serious injury or even death. A Class I recall is the FDA’s most serious type of recall and is issued only when there is a reasonable probability that use of a defective medical device will cause serious injury or death. According to the FDA recall notice, Medtronic notified its customers of the SynchroMed El Implantable Infusion Pump via a letter dated August 3, 2007.
The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System. According to the FDA, the Medtronic Inc. SynchroMed El Implantable Infusion Pump administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The Medtronic SynchroMed El Implantable Infusion Pump recall involved models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. Only those models with motors manufactured before September 1999 are affected by the recall.
The Medtronic SynchroMed El Implantable Infusion 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 underinfusion or withdrawal. According to the FDA, drug withdrawal from Intrathecal Baclofen (ITB) therapy (in the patient’s spine) can cause death if not treated immediately and effectively.
Consumers with questions about the Medtronic SynchroMed El Implantable Infusion Pump recall can contact Medtronic Neuromodulation Patient Services at 1-800-510-6735.