BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4173544 · Received October 15, 2014

    Report

    Report Number
    1644487-2014-02692
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO END OF SERVICE, THE VNS PATIENT¿S REPLACEMENT DEVICE WAS OPENED BUT NOT USED AS THE SURGEON WAS UNABLE TO LOCK THE SETSCREW. ANOTHER GENERATOR WAS USED FOR THE REPLACEMENT. THE UNUSED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED AND FOUND THAT THE SETSCREW SOCKET WAS STRIPPED. THE RETURNED TORQUE WRENCH SHOWED THAT THE HEX SHAFT END WAS DAMAGED AND ROUNDED (NON-HEX SHAPED). THE EVENT WAS LIKELY CAUSED BY INCOMPLETE INSERTION OF THE TORQUE WRENCH SHAFT INTO THE SETSCREW SOCKET AND USER-RELATED. NO DEVICE MALFUNCTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652722 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202930

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR