BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1132726 · Received August 21, 2008

    Report

    Report Number
    1644487-2008-01930
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    IT WAS REPORTED THAT PATIENT RECEIVED HIGH LEAD IMPEDANCE ON SYSTEM DIAGNOSTICS. NO TRAUMA OR PATIENT MANIPULATION OCCURRED. IT IS UNKNOWN WHEN LAST GOOD DIAGNOSTICS WERE OBTAINED. X-RAYS WERE REVIEWED BY THE MANUFACTURER, AND A GROSS LEAD FRACTURE WAS VISUALIZED NEAR THE ANCHOR TETHER ON THE NEGATIVE LEAD WIRE. PATIENT'S GENERATOR SETTINGS WERE SET TO ZERO. PATIENT WILL HAVE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 6055

    Patients

    Seq Age Sex Outcome Treatment
    1