BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2130001 · Received June 10, 2011

    Report

    Report Number
    1644487-2011-01282
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    November 1, 2010
    Report Date
    May 13, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTED IN A PT'S CLINIC NOTES THAT SHE HAD AN INCREASE IN SEIZURE FREQUENCY AROUND THANKSGIVING 2010. FURTHERMORE, THE PT "DID NOT DO WELL AROUND THE HOLIDAYS", BUT SHE WAS DOING MUCH BETTER BY THE NOTES DATE, (B)(6) 2011. DIAGNOSTIC TESTING ON THE DATE WAS NORMAL. THE PHYSICIAN ADDED THAT THE SEIZURE ACTIVITY WAS DUE TO A DEAD BATTERY, THOUGH DIAGNOSTIC TESTS SHOWED PROPER DEVICE FUNCTION. A REPLACEMENT SURGERY IN THE FUTURE IS LIKELY. ATTEMPTS FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS INC 101 29775C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other