FDA Safety Information
FDA Recalls Implantable Infusion Pump
Medtronic SynchroMed EL Implantable Infusion Pump: FDA
issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion
Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18,
and 8627L-18. The device 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 models were recalled because there is a potential pump
motor stall issue that affects SynchroMed EL infusion pumps with motors
manufactured before September 1999. 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. Health care professionals and patients with questions should contact
the manufacturer.
Read the complete MedWatch
2008 Safety Summary.
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MedWatch notifications.
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