BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1885035 · Received October 20, 2010

    Report

    Report Number
    1644487-2010-02355
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    July 12, 2010
    Report Date
    October 19, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT'S PULSE GENERATOR WAS BEING REPLACED DUE TO END OF SERVICE FROM THE ERI-FLAG OBSERVED DURING THE RECENT INTERROGATION AT THE TIME OF THE REPORT. LATER THE PATIENT WAS REPORTED TO HAVE AN INCREASE IN SEIZURE INTENSITY, WHICH WAS BELIEVED TO BE RELATED TO THE BATTERY DEPLETION. THE EXPLANTED PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, WHICH CONFIRMED THE REPORTED BATTERY DEPLETION. DURING THE ANALYSIS, THE SUPPLY CURRENT TESTS DID NOT MEET FUNCTIONAL SPECIFICATIONS. THESE MEASUREMENTS DEMONSTRATE AN INCREASED CURRENT CONSUMPTION FOR THE DEVICE, POTENTIALLY CONTRIBUTING TO A PREMATURE END OF LIFE CONDITION. THE INCREASED CURRENT CONSUMPTION WAS ISOLATED TO A LEAKY CAPACITOR (C6). WITH THE CAPACITOR SUBSTITUTION FOR C6, THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE FOR THE PREMATURE END OF LIFE CONDITION WAS IDENTIFIED TO BE A LEAKY CAPACITOR, C6. CAUSE FOR THE C6 CAPACITORS INCREASE IN LEAKAGE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 13894

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR