BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 9581320 · Received January 13, 2020

    Report

    Report Number
    1644487-2020-00074
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 13, 2020
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    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 REPORTED THAT THE PATIENT WAS BEING REFERRED FOR PROPHYLACTIC BATTERY REPLACEMENT. AFTER THE REPLACEMENT, THE GENERATOR WAS SENT BACK FOR PRODUCT ANALYSIS TO BE PERFORMED. PRODUCT ANALYSIS (PA) WAS PERFORMED ON THE GENERATOR RETURNED. THE ELECTRICAL TESTS PERFORMED IN THE PA LAB FOUND THAT THE GENERATOR WAS AT AN IFI = NO CONDITION. THE BATTERY VOLTAGE WAS MEASURED AT 2.864 VOLTS, AND THE MEMORY LOCATIONS ON THE GENERATOR INDICATED THAT 82.618% OF THE BATTERY HAD BEEN CONSUMED. CONTAMINATES WERE VISUALIZED ON THE TRIMMED EDGE SO THE GENERATOR WAS OPENED. THE BATTERY VOLTAGE WAS MEASURED AGAIN AT 2.904 VOLTS, RESULTING IN AN IFI=NO CONDITION. THE RESULTS FROM THE POSTBURN ELECTRICAL TEST CONCLUDED THAT THE CONTAMINATES OBSERVED CONTRIBUTED TO THE SUPPLY CURRENT CONDITIONS. THE REMAINING RESIDUAL MATERIAL ON THE PCBA EDGE AFTER THE ¿TEST TAB¿ REMOVAL MANUFACTURING PROCESS RESULTED IN INCREASED CURRENT CONSUMPTION (OUT OF SPECIATION) FOR THE PULSING MODE OF OPERATION. THE DEVICE HISTORY RECORDS OF THE GENERATOR WAS REVIEWED IN WHICH IT WAS CONFIRMED THAT ALL PARAMETERS PASSED INSPECTION AND THAT THE TRIM TEST TAB WAS PERFORMED WHICH WAS PRIOR TO THE MANUFACTURING PROCESS BEING CORRECTED; THEREFORE, THE GENERATOR OF INTEREST IS PART OF THE LASER ROUTING ISSUE WHICH WOULD CAUSE PREMATURE EOS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46065 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 203476 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR