BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LEAD

    MDR report key: 3192688 · Received June 27, 2013

    Report

    Report Number
    3007566237-2013-02128
    Event Type
    Malfunction
    Date Received
    June 27, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLIP ON THE STIMLOC WAS FRAGILE AND BROKE EASILY. IT WAS ALSO REPORTED THE HEALTHCARE PROVIDER STATED THE STIMLOC WAS A ¿PIECE OF CRAP BUT BETTER THAN OTHERS.¿ 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
    293403 UNKNOWN LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1