BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1232721 · Received November 14, 2008

    Report

    Report Number
    1644487-2008-02758
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUTPUT WAS DISABLED. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS GENERATOR WAS NOT USED FOR AN IMPLANT SURGERY BECAUSE IT WAS "DEFECTIVE". ALL ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE GENERATOR WAS RETURNED FOR ANALYSIS WITH PAPERWORK STATING "0 YEARS OF BATTERY LIFE REMAINING". ANALYSIS OF THE GENERATOR NOTED THAT THE END-OF SERVICE WARNING MESSAGE WAS VERIFIED AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. A ROOT CAUSE FOR THIS CONDITION COULD NOT BE DETERMINED. ONCE THE OUTPUT WAS RE-ENABLED, ELECTRICAL TESTS SHOWED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. FURTHER INVESTIGATION IS BEING CONDUCTED TO IDENTIFY THE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PUSLE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2151

    Patients

    Seq Age Sex Outcome Treatment
    1