BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1070426 · Received July 3, 2008

    Report

    Report Number
    1644487-2008-01541
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 6, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DIAGNOSTIC TESTING HAD RESULTED IN HIGH LEAD IMPEDANCE AT A ROUTINE OFFICE VISIT. THERE WAS NO REPORT OF PT TRAUMA OR MANIPULATION THAT COULD HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. X-RAYS WERE REVIEWED BY THE MFR. NO GROSS LEAD DISCONTINUITIES WERE IDENTIFIED. LEAD REVISION SURGERY WAS PERFORMED. AFTER THE SURGERY, THE SURGEON INDICATED HE BELIEVED THE HIGH LEAD IMPEDANCE WAS TO AN "UNUSUAL AMOUNT OF SCARRING ON THE LEAD." WITH THE NEW LEAD, DIAGNOSTIC TESTING WAS NORMAL. GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED LEAD FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female