BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1872841 · Received October 14, 2010

    Report

    Report Number
    1644487-2010-02296
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    May 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT WAS HAVING INCREASED SEIZURES, AND IT WAS BELIEVED THAT VNS GENERATOR WAS NEARING END OF SERVICE, EVEN THOUGH THE END OF SERVICE INDICATOR WAS NO UPON INTERROGATION, AND DIAGNOSTICS RESULTS WERE NORMAL. THE PT LATER HAD PROPHYLACTIC GENERATOR REPLACEMENT SURGERY. ATTEMPTS FOR FURTHER INFO AND RETURN OF THE EXPLANTED GENERATOR ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 11537

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention