BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPG NEURO

    MDR report key: 1040050 · Received May 7, 2008

    Report

    Report Number
    2182207-2008-02422
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS A PASSENGER IN THE CAR ON THEIR WAY HOME WITH THEIR ENS FOR A STIMULATION TRIAL. THEY DROVE UNDER SOME BIG POWER LINES, THE PT FELT THE STIMULATION GET VERY STRONG AND THEN HE "PASSED OUT FOR A MIN." THE PT WAS INSTRUCTED TO TURN OFF THE DEVICE THE NEXT DAY. THE PT RETURNED TO THE CLINIC AND WAS GIVEN A NEW ENS. THE FIRST ENS WAS INTERROGATED AND "NOTHING LOOKED OUT OF THE ORDINARY". THE TRIAL WAS CONTINUED WITHOUT FURTHER EVENTS. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPG NEURO ENS GZB MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| UNK CONVERSATION TYPE MODEL LEADN| IMPLANTED: