BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2141187 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01398
    Event Type
    Injury
    Date Received
    June 22, 2011
    Report Date
    May 26, 2011
    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 NOTED IN A PATIENT'S CLINICAL INFORMATION THAT THERE HAD BEEN A HISTORY OF SLEEP APNEA AND USE OF A CPAP MACHINE; FURTHERMORE, THE PATIENT WAS HAVING AN INCREASE IN STARING SPELLS. LAST KNOWN DIAGNOSTICS ON (B)(6) 2010 SHOWED THE DEVICE TO BE PROPERLY FUNCTIONING. 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 11863

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other