SynchroMed II implantable drug infusion pump recalled due to potential foreign particles and motor stall

Dec. 17, 2019

Medtronic has recalled its Medtronic SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System. The pump is used together with a catheter to deliver a specific drug to patients’ spinal fluid.

The company received reports of early permanent motor stall due to the potential presence of foreign particles inside the pump motor assembly. Permanent motor stall could prevent the infusion of drugs to a patient, which could cause serious injury, such as drug withdrawal, the return of symptoms of underlying conditions, the need for surgery to replace the pump, or death.

Medtronic has confirmed five reports of motor stall due to the presence of a foreign particle, which resulted in drug withdrawal, surgery to replace the pump, and delay of care. A sixth pump, which was removed surgically due to an unrelated infection, was later found to contain a foreign particle, but there was no indication of a motor stall. No deaths were reported.

On October 9, 2019, Medtronic sent a letter to hospital risk managers and distributors informing them of the affected models and providing instructions on how to identify and return any affected unused product. On December 13, 2019, Medtronic issued an additional notification to healthcare providers to provide further recommendations. Specifically, Medtronic is not recommending prophylactic replacement of potentially affected SynchroMed II pumps, due to the low observed occurrence of motor stall from this issue, the presence of pump alarms, and the risks associated with replacement surgery.

Medtronic recommends that healthcare providers discuss with patients and caregivers the signs and symptoms that could occur from a motor stall.

FDA has the release.