BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2182411 · Received July 11, 2011

    Report

    Report Number
    1644487-2011-01543
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT THE PT CAME INTO THE OFFICE "NOT FEELING THE VNS". THE PT WAS SAID TO BE VERY DEPRESSED, SO DIAGNOSTIC TESTING WAS PERFORMED, WHICH RESULTED IN HIGH IMPEDANCE. THE DEVICE WAS DISABLED AND X-RAYS WERE TAKEN. THERE WAS NO KNOWN TRAUMA OR MANIPULATION TO THE PT OR DEVICE. THE X-RAYS WERE REVIEWED BY THE MFR. THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED, THE FILTER FEED THRU WIRES APPEARED INTACT, AND THE LEAD WIRES APPEARED INTACT AT THE CONNECTOR PIN. NO OBVIOUS DISCONTINUITIES WERE OBSERVED. HOWEVER, AN ACUTE ANGLE IN THE LEAD BODY WAS NOTED WHERE THE LEAD EXITS THE FINAL TIE-DOWN BEFORE HEADING CAUDALLY TOWARD THE GENERATOR CAN. THE PT'S LAST KNOWN SETTINGS WERE FROM (B)(6) 2010 AND LAST KNOWN DIAGNOSTICS ON (B)(6) 2009 SHOWED THE DEVICE TO BE PROPERLY FUNCTIONING. A REVISION SURGERY IN THE FUTURE IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1920

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR