BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 1041282 · Received May 9, 2008

    Report

    Report Number
    1644487-2008-01120
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    January 1, 2006
    Report Date
    April 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THE PATIENT HAD HIGH LEAD IMPEDANCE ON BOTH THEIR NORMAL MODE DIAGNOSTICS AND SYSTEM TEST. INDICATING A LIKELY DEVICE MALFUNCTION. NO REPOT OF A FALL OR INJURY PRECEDING THE EVENT. THE PATIENT UNDERWENT FULL REVISION SURGERY. IT WAS REPORTED AS NOTED IN THE OR. THAT "THERE IS A LOT OF FLUID IN THE BOTTOM RECEPTOR OF THE GENERATOR. THE METAL PIN OF THE TOP LEAD IS STILL IN THE GENERATOR, WITH THE BARE WIRE COMING OUT OF THE PIN AND THEN ABOUT 2 IN LATER, THE PLASTIC COATING ON THE LEAD STARTS. IT SEEMS LIKE THE PLASTIC COATING HAS DETACHED FROM THE METAL PIN TIP AND HAS PULLED BACK ON THE WIRE EXPOSING 2IN OF THE BARE WIRE. "REVIEW OF INTERNAL PROGRAMMING HISTORY SHOWED THE PATIENT HAD HIGH LEAD IMPEDANCE SINCE 2006. THE EXPLANTED PRODUCT IS AT MANUFACTURER PENDING ANALYSIS COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 13667C

    Patients

    Seq Age Sex Outcome Treatment
    1