BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6092437 · Received November 10, 2016

    Report

    Report Number
    3007566237-2016-04006
    Event Type
    Death
    Date Received
    November 10, 2016
    Report Date
    December 6, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED IT WAS UNKNOWN IF THE DEATH WAS RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    A CONSUMER REPORTED A PATIENT WAS (B)(6) AND THEIR HUSBAND QUIT HELPING THEM TAKE CARE OF THEIR SYSTEM SO THEY "DIDN'T KEEP UP WITH IT," AND DIED. THE CONSUMER WANTED TO KNOW WHAT THEY NEEDED TO DO TO "KEEP UP WITH IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745702 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death