Personal Injury Law

FDA Warning - Medtronic Inc. SynchroMed EL Implantable Infusion Pump

By Steve Lombardi

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 defect (a 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. Healthcare professionals and patients with questions should contact the manufacturer.

This is a serious issue concerning an implant that has a history and should not be taken lightly.

Explanation of the Issue - Between December, 2005 and March, 2006 Medtronic received reports of nine patient deaths within three days after the initiation - or re-initiation following interrupted use - of intrathecal opioid therapy for pain. The cases involved new system implants, catheter revisions, and system replacements. Medtronic has concluded the patient deaths were most likely caused by opioid and/or sedative drug overdose.

Full post as published by Des Moines Personal Injury Lawyer on February 05, 2008 (boomark / email).