BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1172598 · Received September 19, 2008

    Report

    Report Number
    1644487-2008-02276
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    April 1, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. A BATTERY LIFE CALCULATION WAS DONE AND SHOWED THAT THERE SHOULD BE APPROXIMATELY 3.32 YEARS REMAINING UNTIL BATTERY END-OF- SERVICE. REVISION SURGERY IS PLANNED, BUT NOT YET SCHEDULED. ATTEMPTS FOR FURTHER INFORMATION ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 014788

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention