BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1831816 · Received September 8, 2010

    Report

    Report Number
    1644487-2010-02053
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    June 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE SURGEON THAT THE PATIENT HAD HIS BATTERY REPLACED DUE TO END OF SERVICE, ERI (ELECTIVE REPLACEMENT INDICATOR) = YES. EXPLANTED GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR AND THE REPORTED ALLEGATION WAS VERIFIED. HOWEVER, THE CAPACITOR C11 WAS FOUND TO EXHIBIT AN OUT-OF-LIMIT LEAKAGE CURRENT. THIS LEAKAGE INCREASED THE MODULE'S SUPPLY CURRENT, WAIT CONSUMPTION. THE OUT-OF-LIMIT "WAIT" CURRENT COULD POTENTIALLY BY A CONTRIBUTING FACTOR TO THE EOS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR