BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1063660 · Received June 20, 2008

    Report

    Report Number
    1644487-2008-01434
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 14, 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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULT CODE: X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTUITIES VISUALIZED. 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 THAT COMMUNICATION COULD NOT BE ESTABLISHED WITH A VNS PATIENT'S GENERATOR. X-RAYS WERE SENT TO THE MANUFACTURER TO REVIEW. REVIEW OF THE X-RAYS REVEALED NO ANOMALIES WITH THE GENERATOR OR LEAD. NO LEAD DISCONTINUITIES WERE OBSERVED. IT WAS NOTED ON THE X-RAYS THAT THE GENERATOR PLACEMENT APPEARED TO BE PLACED MORE LATERALLY THAN WHAT IS NORMALLY OBSERVED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR