BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 8499145 · Received April 10, 2019

    Report

    Report Number
    1644487-2019-00688
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    June 14, 2016
    Report Date
    April 12, 2019
    Manufacturer
    LIVANOVA USA, INC.
    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

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT, CORRECTED DATA; INITIAL MDR INADVERTENTLY OMITTED DEVICE HISTORY RECORD REVIEW.

    Description of Event or Problem · 1

    DEVICE HISTORY RECORD WAS REVIEWED AN SHOWED THAT THE DEVICE WAS LASER ROUTED AND PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE WAS EXPLANTED AND THE GENERATOR WAS RETURNED AND ANALYSIS WAS APPROVED. THE ELECTRICAL TESTS PERFORMED IN THE ANALYSIS LAB FOUND THAT THE DEVICE WAS MEASURED AT A VOLTAGE OF 2.617 VOLTS CONFIRMING THAT THE DEVICE WAS AT THE IFI = YES CONDITION. HOWEVER, THE MEMORY LOCATIONS REVEALED THAT 30.817% OF THE BATTERY HAD BEEN CONSUMED. DUE TO THIS DISPARITY, THE PULSE GENERATOR WAS OPENED AND FURTHER TESTS WERE CONDUCTED. WITH THE BATTERY STILL ATTACHED TO THE CIRCUIT BOARD (PCBA), THE VOLTAGE WAS MEASURED AT 2.54 VOLTS CONFIRMING THE IFI = YES CONDITION. A VISUAL ASSESSMENT OF THE PCBA SHOWED CONTAMINANTS ON THE TRIMMED EDGE OF THE PCBA. THE DEVICE FAILED SEVERAL POSTBURN ELECTRICAL TESTS; HOWEVER AFTER THE CONTAMINANTS WERE REMOVED FROM THE TRIMMED EDGE OF THE PCBA, THE DEVICE PASSED ALL BUT TWO TEST WHICH WERE FAILED DUE TO THE TEST SOFTWARE REQUIRING UPDATES. THE CONTAMINANTS ON THE PCBA SUGGEST PROBABLE ELECTRICAL PATHS WERE ESTABLISHED WHICH CONTRIBUTED TO THE SUPPLY CURRENT CONDITIONS. THE ANALYSIS THEREFORE CONCLUDED THAT THE CONTAMINANTS ON THE PCBA MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE IFI = YES. THEREFORE THERE IS EVIDENCE THAT THE BATTERY IS DEPLETING FASTER THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292451 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 203824 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR