RECALL Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump

[Mambo]

2/17/2011

FDA Recall:
The Food and Drug Administration has announced a Class 1 Recall of the Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits. The pump and infusion system are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patient’s body. The refill kit is used in refilling most Medtronic implantable infusion pumps. A Medtronic Lawsuit may begin.
The federal agency warned that pocket fills, or 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.
The affected products are:
• SynchroMed II (Model No. 8637)
• SynchroMed EL (Model Nos. 8626 and 8627)
• Refill Kits (Model Nos. 8551, 8555, 8561, 8562, 8564, 8565 and 8566.
The federal agency is recommending that health care professionals check needle placement within the pump septum during the drug refill procedure. Medtronic is warning that it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the pump reservoir.

At every refill, patients and caregivers should be reminded about the signs and symptoms of drug overdose, underdose and withdrawal, the FDA said.
The agency encouraged health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA’S MedWatch Safety Information and Adverse Event Reporting Program. Forms are available on the agency’s Web site at www.fda.gov/MedWatch/report.htm. The recall was announced Feb. 16 at the FDA headquarters in Silver Springs, Md.


Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pumps