BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1000748 · Received February 21, 2008

    Report

    Report Number
    1644487-2008-00353
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    November 27, 2006
    Report Date
    January 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED BUT NOTED THE LEAD PIN APPEARS TO NOT BE FULLY INSERTED. DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SYSTEM DIAGNOSTICS, DURING A ROUTINE OFFICE VISIT RESULTED IN HIGH IMPEDANCE. THE FLASHCARD DATA WAS RECEIVED WITH PROGRAMMING HISTORY. THE HIGH IMPEDANCE DIAGNOSTIC INDICATES A POSSIBLE LEAD MALFUNCTION. NO PT ADVERSE EVENTS OR TRAUMA HAVE BEEN REPORTED. GOOD FAITH ATTEMPTS ARE IN PROGRESS FOR ADDITIONAL INFO AND AWAITING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 4183C

    Patients

    Seq Age Sex Outcome Treatment
    1