More Deaths Linked to Medtronic (MDT) Infusion Pump
11/2/2016 7:14:39 AM
The SynchroMed II implantable drug pump was linked to more than 100 adverse events including 2 previously unreported deaths, Medtronic said last month.
In a letter to doctors published yesterday by the U.K.’s Medicines & Healthcare Products Regulatory Agency, Fridley, Minn.-based Medtronic said the SynchroMed II pump can delivery too much medicine but that the exact case of the overinfusion isn’t clear.
Last year the company signed a consent decree with the FDA after years of problems with the device, agreeing to halt the manufacture of SynchroMed II after repeatedly failing to correct violations found by the FDA over a 7-year period.
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