FDA Reprimands Medtronic Regarding Pumps
The world’s largest medical device maker, Medtronic, has been recently censured by the FDA for consumer complaints arising out of certain medical devices.
FDA Criticizes Medtronic for Device Defects
The FDA sent a letter reprimanding Medtronic Inc. – a respected and dominant medical device maker – regarding Medtronic’s failure to address the hundreds of complaints coming from the use of Medtronic’s drug infusion pumps. FDA’s letter was sent July 17, and details the “SynchroMed II” infusion pump.
- The letter describes a defect which causes the pump's motor to deteriorate, stall, and eventually cease the delivery of drugs.
- The device, which is implantable under the skin near the spinal cord, is programmable by a clinician.
- The device is used to deliver medications for treatment of severe and chronic pain from nerve injuries and cancer.
- The defects were discovered in 2007.
- According to the FDA letter, since the device has come out, there have been over 560 complaints about adverse effects from the device.
- Complaints include reports of worsened pain after use, withdrawal symptoms, and unexplained vibrations of the device.
Spokeswoman for Medtronic’s neuromodulation unit, Donna Marquard, who oversees development and use of the pump, answered questions in a recent Forbes article. She said Medtronic is working to resolve the findings, and consumers should know that the warning does not require action by consumers or doctors.
When asked by Forbes how long it would take to fix the problem, Marquard said it was difficult to say, but noted that the sale and support of approved therapies, which includes the SynchroMed pump, is not affected by this action.
- Medtronic issued a news release about the SynchroMed II Implantable Drug Infusion Pumps.
- Medtronic said the SynchroMed II pump’s problem is related to the formation of a film within the pump battery that may impact battery performance.
- This can lead to the sudden loss of therapy and the return of underlying symptoms and/or withdrawal symptoms.
- More information regarding potential problems with the SynchroMed II pump and corrective responses can be found on their website.
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