BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LEAD

    MDR report key: 3202948 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02198
    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 SCREWS ON THE BASE ASSEMBLY FELL OUT. IT WAS SUGGESTED THAT THE BASE ASSEMBLY SHOULD BE SCREWLESS. NO FURTHER IN FORMATION 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
    300880 UNKNOWN LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1