Medtronic Recalls Drug Infusion Pump due to Permanent Stalling
On December 13, 2019, Medtronic circulated a letter warning healthcare providers of a stalling issue with the Synchromed II, an implantable drug infusion pump manufactured and distributed by the firm. The infusion pumps are used in combination with a catheter to deliver specific prescribed drugs into a patient’s body in a controlled manner. However, Medtronic has received several reports of the pump’s motors permanently stalling due to the potential presence of foreign particles inside the pump motor assembly. A permanent stall could prevent the infusion of drugs to the patient. The pump’s failure to deliver a patient’s prescribed drugs can lead to serious injuries, such as drug withdrawal, the return of symptoms of the underlying conditions, the need for surgery to replace the pump, or even death.
Medtronic’s Synchromed II drug infusion pumps are frequently found in patients receiving baclofen therapy to treat severe spasticity, a condition that makes muscles feel difficult to move potentially to the point that the muscles feel locked. A patient suffering from severe spasticity can be prescribed Lioresal (baclofen) injections to be delivered to the patient’s spinal fluid through a Synchromed II pump placed under the skin of the patient’s abdomen. The pump will be programmed to deliver the patient his or her appropriate daily dose of baclofen. However, if the pump permanently stalls and the drug is no longer delivered, the patient may suffer from Baclofen Withdrawal Syndrome, which can be life-threatening.
On October 9, 2019, Medtronic initiated a recall of 7,317 of its Synchromed II pumps distributed between May 11, 2018 and April 5, 2019. Despite the recall, Medtronic is not requiring implanted pumps be replaced, but is requesting the return of any unused Synchromed II pumps.
If you or a loved one has suffered injuries that you suspect could be attributed to a Medtronic Synchromed II implantable drug infusion pump, contact one of the experienced product liability attorneys at Burg Simpson’s Cincinnati office today. Our award-winning lawyers have a storied history of fighting dangerous device manufacturers who refuse to take responsibility for the harm they cause, and possess the knowledge and resources to investigate your potential claim. Call 1-513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.