BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1854245 · Received September 30, 2010

    Report

    Report Number
    3007566237-2010-07486
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, LEADS (MODEL 3387-28) AND EXTENSIONS (MODEL 37082) WOULD NOT FIT TOGETHER. AFTER TUNNELING THE EXTENSIONS TO THE IMPLANTED DEVICE AND THEN TRYING TO CONNECT THEM WITH THE 4 LEADS, THE PROXIMAL PART OF THE LEAD COULD NOT BE INSERTED IN A NORMAL WAY. THE PHYSICIAN HAD TO DRILL OUT ALL 4 SCREWS OF THE CONNECTOR BLOCK OF THE EXTENSIONS, AND HAD TO USE AN AQUA DEST FOR MAKING IT POSSIBLE TO GET THE LEAD INTO THE CONNECTOR BLOCK OF THE EXTENSION. IT WAS NOTED TO BE VERY DIFFICULT AND TIME CONSUMING TO BRING THE LEAD INTO THE EXTENSION. IT WAS NOTED THAT THIS HAD HAPPENED ON TWO OCCASIONS ON (B)(6) 2010 AND (B)(6) 2010. SEE MFR REPORT #3007566237-2010-05993.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION: MODEL 37082, LOT # NKB006449V| EXPLANTED:| IMPLANTED: