BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1936142 · Received December 13, 2010

    Report

    Report Number
    1644487-2010-02787
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 11, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS SCHEDULED FOR A BATTERY REPLACEMENT SURGERY DUE TO GENERATOR WAS THOUGHT TO BE AT END OF LIFE. PT WAS HOSPITALIZED DUE TO STATUS AND VNS COULD NOT BE INTERROGATED. PT WAS TAKEN INTO SURGERY; HOWEVER, THE SURGEON WAS ABLE TO INTERROGATE THE DEVICE AND THE GENERATOR WAS NOT CONFIRMED TO BE AT END OF SERVICE. REASON FOR INCREASE IN SEIZURES IS UNK. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 NONE LYJ CYBERONICS, INC. 102 013407

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention