BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2030870 · Received March 4, 2011

    Report

    Report Number
    3007566237-2011-01632
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD IMPLANT PROCEDURE THE LEAD WAS REMOVED FROM THE PACKAGE AND IT WAS OBSERVED THAT IT HAD A "SMALL CURVE" TO IT. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 0203385250

    Patients

    Seq Age Sex Outcome Treatment
    1