BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE STIMULATION LEAD

    MDR report key: 3241145 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02426
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-1190-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASING ON THE LEAD CAP MOVES ALONG WITH THE TORQUE WRENCH. THE SURGEON HAD TO SQUEEZE THE CASING TO HOLD THE BASE OF THE SCREW STILL SO THAT IT DID NOT ROTATE WHILE SCREWING THE SCREW. THE CASING ON THE OUTSIDE OF THE SCREW WAS ROTATING ALONG WITH THE SCREW. IT WAS NOTED THAT THE SURGERY WAS ABLE TO BE CONTINUED AS PLANNED AND THE OUTCOME WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340576 UNKNOWN IMPLANTABLE STIMULATION LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1