BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1063530 · Received June 19, 2008

    Report

    Report Number
    1644487-2008-01427
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    February 27, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN OPENED, BUT UNUSED GENERATOR WAS RETURNED TO CYBERONICS FROM A HOSPITAL. THE SITE INDICATED THE GENERATOR "WOULD NOT PROPERLY RESPOND TO COMPUTER. NEW GENERATOR OPENED. SAME THING HAPPENED. NEW COMPUTER OBTAINED, 2ND GENERATOR OK." THE GENERATOR IS UNDERGOING ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1