Medtronic Forced to Recall Pump Over Battery Flaw

The U.S. Food and Drug Administration has announced that the newly recalled Medtronic SynchroMed II Implantable Infusion Pump has a battery flaw that could be deadly. The pump is designed to deliver drugs to a specific site, including morphine sulfate for chronic pain, ziconotide for severe chronic pain, baclofen for severe spasticity, as well as floxuridine and methotrexate for primary or metastatic cancer. The recalled pump includes SynchroMed II models 8637-20 and 8637-40, which were distributed between 2004 and July 2011.

Patients are seriously harmed when “special interests permeate medical research.”

Medtronic has stated that the device malfunctions because of a film that forms on the battery of the pump. There are serious risks due to the failure of the pump, as there have already been 55 reported cases and one death related to drug withdrawal. Though the device is implantable, patients are not being advised to have the pump removed. Instead, patients are being told that they should contact their doctor if they experience symptoms or hear the device alarm.

Medtronic is the nation’s largest medical device manufacturer, with $15.9 billion in sales and $3.1 billion in profit last year. The company came under fire over the summer when the nation’s leading spine periodical, The Spine Journal, implied that Medtronic may have hidden serious side effects of Infuse, a popular bone growth product. The authors of the report called into question previous research done by scientists on the Medtronic payroll, calling it “biased and corrupted” and saying that patients are seriously harmed when “special interests permeate medical research.”

Patients who were injured due to a recalled medical device or drug may be entitled to compensation for medical bills, lost wages, and pain and suffering. Contact a product liability attorney today if you or a loved one was harmed due to a faulty medical device or medication.