BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2680340 · Received June 5, 2007

    Report

    Report Number
    1644487-2007-00766
    Event Type
    Malfunction
    Date Received
    June 5, 2007
    Date of Event
    January 1, 2007
    Report Date
    May 7, 2007
    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

    PT X-RAYS ASSESSED BY MFR. LEAD DISCONTINUITY NOTED DURING REVIEW OF X-RAYS. DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    RPTR INDICATED THAT PT PRESENTED FOR ROUTINE OFFICE WHERE HIGH LEAD IMPEDANCE WAS OBTAINED DURING SYSTEM DIAGNOSTIC TESTING INDICATING A POSSIBLE LEAD MALFUNCTION. PT X-RAY WERE SUBSEQUENTLY TAKEN AND SENT IN TO MFR FOR ASSESSMENT. REVIEW OF X-RAYS YIELDED A POSSIBLE LEAD DISCONTINUITY, WHICH WAS NOTED TO BE ADJACENT TO ONE OF THE PT'S TIE-DOWNS. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5549

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR