BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 302

    MDR report key: 1060002 · Received June 10, 2008

    Report

    Report Number
    1644487-2008-01343
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 13, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    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 - DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A PT HAD HIGH LEAD IMPEDANCE. NO TRAUMA OR DEVICE MANIPULATION WAS ADMITTED. THE VNS WAS DISABLED. MFR REVIEW OF X-RAYS DID NOT IDENTIFY ANY LEAD DISCONTINUITIES. A SURGERY CONSULT IS SCHEDULED FOR 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR