Medtronic SynchroMed® Implantable Drug Pump Linked to 14 Deaths
The deaths of fourteen patients have been attributed to problems involving the SynchroMed® implantable drug pump, a device manufactured by Medtronic and used to deliver drugs directly to the cerebral spinal fluid in patients who suffer from chronic, intractable pain or severe spasticity. Of the fourteen deaths, eleven were allegedly caused by medication being inadvertently injected into the tissue surrounding the implanted pump, two by a blockage in the catheter that delivers the medication from the pump, and one due to the device short-circuiting. The deaths occurred during the period between May 1996 and April 2013.
In response, Medtronic issued four medical device notifications warning physicians of these potential problems and providing them with special instructions for the device’s use. The FDA has recently classified three of these notification as Class I recalls, while the fourth is an update to a 2011 recall involving the device’s pump refill process.
Patients are encouraged to maintain regular follow-up appointments with their doctors, but have been told to seek immediate medical attention if any problems relating to the device arise.
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