BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2250679 · Received September 12, 2011

    Report

    Report Number
    9614453-2011-07738
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 31, 2011
    Report Date
    October 31, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR FOUND NO ANOMALY. THE CONNECTOR MODULE, ACCESS HOLD ADHESIVE, GROMMETS, SETSCREWS, AND INS CAN WERE OK. THERE WAS FOREIGN MATERIAL IN THE CONNECTOR PORTS. TELEMETRY WAS OK AND THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODE PAIRS. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. THE INS FUNCTIONED PROPERLY UNDER A LONG TERM MONITOR TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SWITCHED OFF BY ITSELF. THE DEVICE WOULD TURN OFF MANY TIMES A DAY AND SOMETIMES 2-3 TIMES A WEEK. THE PT HAD BEEN OBSERVED IN THE HOSPITAL AND HAD NOT BEEN IN CONTACT WITH MAGNETS OR OTHER DEVICES. THE DEVICE WAS REPLACED AND THE NEW ONE WORKED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC EUROPE SARL 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention