BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LEAD

    MDR report key: 3202932 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02200
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROVIDER HAD A PROBLEM WITH SOME DOWNWARD MOVEMENT OF THE LEAD WHEN THE STIMLOC COVER WAS SNAPPED ON. NO FURTHERE INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302844 UNKNOWN LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1