BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2191760 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05685
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 27, 2011
    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). ANALYSIS OF THE LEAD FOUND THE DISTAL TIP OF THE LEAD WAS BENT. THE PROXIMAL END WAS INTACT AND UNDAMAGED. THE OUTER INSULATION WAS INTACT AS WELL. CONTINUITY WAS ACCEPTABLE WITH NO SHORTS (DRY).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, A NEW LEAD WAS OPENED AND ELECTRODE 0 WAS FOUND TO BE BENT. NO PT INJURY OCCURRED AS THE LEAD WAS NEVER IMPLANTED. A NEW LEAD WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 0206593012

    Patients

    Seq Age Sex Outcome Treatment
    1