BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBS NEUROSTIMULATOR

    MDR report key: 2772348 · Received October 4, 2012

    Report

    Report Number
    3007566237-2012-02385
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389-28, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL DOWN AND THE CONDITION WORSENED. THE HCP ASSUMED THE LEFT LEAD HAD BROKEN, AND IT WAS REPORTED THAT THERE WAS A SHORT CIRCUIT ON ELECTRODE PAIR 2/3. THE LEAD WAS REPLACED AND IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM THE OPERATION WITH NO OTHER COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention