BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2955031 · Received February 11, 2013

    Report

    Report Number
    1644487-2013-00357
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    August 1, 2005
    Report Date
    January 14, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A GENERATOR WAS RETURNED DUE TO BATTERY DEPLETION. PRODUCT ANALYSIS WAS COMPLETED AND IT WAS CONFIRMED THAT THE GENERATOR WAS AT EOS, AND THE BATTERY VOLTAGE WAS 1.64V. THE GENERATOR DID NOT COMMUNICATE. IT WAS CONFIRMED THAT THERE WAS A LEAKY C6 CAPACITOR. THE UNIT WAS CONFIRMED AT EOS AS RESULT OF BATTERY DEPLETION. 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. A BATTERY LIFE ESTIMATION RESULTED IN 0.99 YEARS REMAINING BEFORE THE ERI FLAG WOULD BE SET. 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. THE CAUSE FOR THE C6 CAPACITORS INCREASE IN LEAKAGE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58164 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 013476

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR