BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1053151 · Received May 27, 2008

    Report

    Report Number
    1644487-2008-01223
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 6, 2008
    Report Date
    April 29, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT DURING AN INITIAL IMPLANT SURGERY, THE SURGEON IMPLANTED A LEAD AND GENERATOR AND WHEN A SYSTEM DIAGNOSTIC TEST WAS PERFORMED, HIGH LEAD IMPEDANCE RESULTED. TROUBLESHOOTING WAS PERFORMED THAT INCLUDED REPOSITIONING THE ELECTRODES SEVERAL TIMES AND THE HIGH LEAD IMPEDANCE REMAINED. A NEW LEAD WAS IMPLANTED AND TESTED WITH THE GENERATOR AND HIGH LEAD IMPEDANCE STILL RESULTED WHEN TESTED. A NEW GENERATOR WAS THEN USED AND THE HIGH LEAD IMPEDANCE RESOLVED. THE INITIAL LEAD AND GENERATOR WERE RETURNED TO MANUFACTURER AND ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200604

    Patients

    Seq Age Sex Outcome Treatment
    1