BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1936649 · Received December 17, 2010

    Report

    Report Number
    1644487-2010-02845
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 17, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6), 2010, AFTER WHICH SHE FELL INTO A STATUS OF EPILEPTICUS WITH COMPLEX PARTIAL SEIZURE (STIMULATION NOT TURNED ON AT THAT TIME), WHICH SHE HAD NOT EXPERIENCED BEFORE. DUE TO THIS CONDITION, THE PATIENT HAS BEEN IN AN INTENSIVE CARE UNIT AND HAS RECEIVED AED ON HIGH DOSE SINCE (B)(6), 2010. THE PATIENT STABILIZED, BUT REMAINED IN THE ICU AS OF (B)(6), 2010, AND THE STIMULATION HAS BEEN TURNED ON. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 2379

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R