BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1031398 · Received April 18, 2008

    Report

    Report Number
    1644487-2008-00958
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 ON A VNS PT RESULTED IN HIGH LEAD IMPEDANCE. THERE WERE NO REPORTS OF TRAUMA. THE PT REPORTS THAT HE CANNOT FEEL STIMULATION. GOOD FAITH ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-30

    Patients

    Seq Age Sex Outcome Treatment
    1