U.S. Food and Drug Administration12.17.19
Recalled Product
The Medtronic SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, is used to deliver prescribed drugs into a patient’s body in a controlled manner. The pump is used together with a catheter to deliver a specific drug to the patient’s spinal fluid.
Medtronic 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 the 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.
Health care providers who manage patients who use the Medtronic SynchroMed II implantable drug infusion pump and patients who receive medications delivered by the Medtronic SynchroMed II implantable drug infusion pump may be affected.
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.
Additionally, Medtronic advised healthcare providers to consider contacting their patients and caregivers and inform them to:
- SynchroMed II pump, Model numbers 8637-20 and 8637-40
- Manufacturing Dates: May 4, 2018 to April 5, 2019
- Distribution Dates: May 11, 2018 to September 5, 2019
- Devices Recalled in the U.S.: 7,317
- Date Initiated by Firm: October 9, 2019
The Medtronic SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, is used to deliver prescribed drugs into a patient’s body in a controlled manner. The pump is used together with a catheter to deliver a specific drug to the patient’s spinal fluid.
Medtronic 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 the 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.
Health care providers who manage patients who use the Medtronic SynchroMed II implantable drug infusion pump and patients who receive medications delivered by the Medtronic SynchroMed II implantable drug infusion pump may be affected.
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.
Additionally, Medtronic advised healthcare providers to consider contacting their patients and caregivers and inform them to:
- Be attentive to all alarms, especially critical alarms
- Take the necessary steps in case of an emergency
- Seek immediate medical attention if they notice signs or symptoms of drug withdrawal or of their underlying condition
- Follow the provided instructions if they receive an alert message in the A820 myPTM app (Personal Therapy Manager application)
- Medtronic has provided healthcare providers with a list of patients who have been implanted with a potentially affected pump.
