BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAED MODEL 300

    MDR report key: 1061981 · Received June 13, 2008

    Report

    Report Number
    1644487-2008-01380
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2000
    Report Date
    July 10, 2000
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT RECEIVED HIGH LEAD IMPEDANCE ON SYSTEM DIAGNOSTICS. X-RAYS WERE REVIEWED BY THE MANUFACTURER INDICATING THAT THE POSITIVE CONNECTOR PIN WAS NOT FULLY INSERTED. THERE WAS EXTRA LEAD WIRE BUNDLED AND TANGLED TOGETHER; HOWEVER, NO GROSS FRACTURE OR DISCONTINUITY WERE VISUALIZED. PT HAD REVISION SURGERY. GOOD FAITH ATTEMPTS WERE MADE WITH THIS PHYSICIAN TO OBTAIN FURTHER INFO SURROUNDING THIS EVENT; HOWEVER, THESE ATTEMPTS WENT UNANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAED MODEL 300 LYJ CYBERONICS, INC. 300-20

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other