BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 5942440 · Received September 12, 2016

    Report

    Report Number
    1644487-2016-02049
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    January 22, 2008
    Report Date
    August 23, 2016
    Manufacturer
    CYBERONICS
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT UNDERWENT DEVICE REPLACEMENT SURGERY ON (B)(6) 2015. IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO END OF SERVICE (EOS). THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER ON 04/28/2016. ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED AND IT APPEARED THAT THE GENERATOR WAS RECEIVED AT THE PRODUCT ANALYSIS LABORATORY (PA LAB) WITH AN EOS WARNING MESSAGE AND THE OUTPUT BEING DISABLED DUE TO THE GENERATOR REMAINING ON AFTER EXPLANT. DUE TO THE HIGH IMPEDANCE AND THE GENERATOR REMAINING ON AFTER EXPLANT, A 'VBOOST' VOLTAGE WAS REQUIRED WHICH WAS HIGHER THAN THE MAXIMUM VOLTAGE CAPABILITY FOR THE GENERATOR. THIS IS NOT CONSIDERED A DEVICE FAILURE, BUT IS AN EXPECTED EVENT DUE TO THE GENERATOR REMAINING ON AFTER EXPLANT. THE EOS WARNING MESSAGE WAS VERIFIED BY THE BATTERY VOLTAGE (2.1V) AND THE DATA IN THE DIAGACCUM CONSUMED MEMORY LOCATIONS (85% OF BATTERY CONSUMED). FURTHERMORE A BATTERY LIFE CALCULATION (BLC) RESULTED IN 2.3 YEARS UNTIL NEAR EOS AT TIME OF EXPLANT. SINCE THE GENERATOR REMAINED ON AFTER EXPLANT, AN EXTRA BLC WAS PERFORMED TAKING THIS INTO ACCOUNT. THE GENERATOR HAD 0 YEARS UNTIL NEAR EOS AT THE TIME IT WAS RECEIVED AT THE PA LAB. THE C4 CAPACITOR WAS OUT OF SPECIFICATIONS. THIS DECREASED CAPACITANCE CONDITION IS AN EXPECTED EVENT FOR AN AGED CAPACITOR OF THE TYPE USED FOR C4, AS THE MANUFACTURING TEST LIMITS FOR C4 VALUE DO NOT TAKE AGING INTO ACCOUNT. THIS CONDITION DOES NOT INDICATE A FAILURE OF THE DEVICE OR THE COMPONENT, AND IS NOT EXPECTED TO HAVE AN ADVERSE EFFECT ON BATTERY LONGEVITY. THE SUPPLY CURRENT OFF-TIME TEST DID NOT MEET ITS FUNCTIONAL SPECIFICATIONS. THIS MEASUREMENT DEMONSTRATES AN INCREASED CURRENT CONSUMPTION FOR THE DEVICE, POTENTIALLY CONTRIBUTING TO END-OF-SERVICE. WHEN THE C3 CAPACITOR WAS CHANGED WITH ANOTHER C3 CAPACITOR, THIS PROBLEM NO LONGER OCCURRED. THE CAUSE FOR THE CAPACITORS (C3) INCREASE IN LEAKAGE COULD NOT BE DETERMINED. THE AMOUNT THAT THE CAPACITOR (C3) MAY HAVE POTENTIALLY CONTRIBUTED TO END-OF-SERVICE (EOS) COULD NOT BE DETERMINED; SINCE THE MOST PROBABLE ROOT CAUSE FOR THE EOS IS THE GENERATOR REMAINING ON AFTER EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595929 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS 104 200699

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR