BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1062998 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01408
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 21, 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

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT BOTH SYSTEM AND NORMAL MODE DIAGNOSTIC TESTS RESULTED IN HIGH LEAD IMPEDANCE AT A ROUTINE OFFICE VISIT. X-RAYS WERE REVIEWED BY THE MANUFACTURER AND A LEAD DISCONTINUITY WAS IDENTIFIED IN THE AREA NEAR THE LEAD BIFURCATION. IT WAS NOTED THAT THE STRAIN RELIEF DID NOT APPEAR TO BE PLACED PER RECOMMENDATIONS IN LABELING. REVISION SURGERY IS LIKELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1