BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2081079 · Received April 14, 2011

    Report

    Report Number
    1644487-2011-00807
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    December 9, 2010
    Report Date
    March 15, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING MANUFACTURER PRODUCT ANALYSIS FOR A VNS GENERATOR THAT WAS REPLACED DUE TO THE ELECTIVE REPLACEMENT INDICATOR SET TO YES, IT WAS NOTED THE SUPPLY CURRENT TESTS DID NOT MEET THE FUNCTIONAL SPECIFICATIONS. THESE MEASUREMENTS DEMONSTRATE AN INCREASED CURRENT CONSUMPTION FOR THE DEVICE, POTENTIALLY CONTRIBUTING TO A PREMATURE END OF LIFE CONDITION. A BATTERY LIFE ESTIMATION RESULTED IN 1.05 YEARS UNTIL END OF SERVICE BUT THERE ARE LARGE GAPS IN THE PROGRAMMING HISTORY USED FOR THE ESTIMATION. THE INCREASED CURRENT CONSUMPTION WAS ISOLATED TO A LEAKY CAPACITOR (C6). BY SUBSTITUTING A KNOWN GOOD CAPACITOR FOR C6, THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE FOR THE POSSIBLE PREMATURE END OF LIFE CONDITION AND SUPPLY CURRENT OUT OF SPECIFICATION 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 014188

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR