Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits

By Lucy Campbell

Washington, DC: Medtronic is issuing a Class I recall of Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits. Pocket fills (the unintended injection of drugs or fluids into the patient's subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm, serious injury, and/or death due to drug overdose or underdose. Products Affected:

SynchroMed II (Model No: 8637)
SynchroMed EL (Model No: 8626 and 8627)
Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, and 8566)

The SynchroMed II Programmable Pump and the SynchroMed EL Infusion System are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patient's body. The Medtronic refill kit is used in refilling Medtronic implantable infusion pumps, with the exception of Medtronic MiniMed Infusion Pumps.

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Published on Feb-16-11

READER COMMENTS

Posted by
Zane Beaty
on July 7, 2019

I have had a Medtronic Pain pump since 9/24/12 and had a dye study test done 12/17 and showed a huge cyst where my catheter tip was. My pain got worse and this pat April 16th, 2019 had my pump and catheter replaced due to its time to be replaced. When the surgeon went in during surgery he had to implant the new catheter above my cyst T12 caused by first pump catheter and replaced the catheter and pump at that time. I want to aggressively go after Medtronic since they knew the 8637-20 pumps caused these issues and did not notify me after I called them numerous times about severe pain.
No neurosurgeon will perform surgery to remove the cyst saying "The risk outweighs the benefit" as I have aggressively visited numerous and will not perform surgery to long on table to remove cyst wrapped around my spinal column.

I have MRIs and post op report that clearly shows the cyst surgeon mentioned in report. I need legal representation as soon as I can. My health is bad and want to hold accountable since I can't work any longer loss wages, anguish, etc... pain...............

Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits

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READER COMMENTS

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