BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 8121520 · Received November 30, 2018

    Report

    Report Number
    1644487-2018-02174
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    June 30, 2015
    Report Date
    September 4, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED THE INCORRECT PATIENT AGE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE PATIENT'S VNS GENERATOR WAS REPLACED. IT WAS NOTED THAT THE EXPLANTED DEVICE WILL BE RETURNED TO MANUFACTURER, HOWEVER THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RETURNED AND RECEIVED BY MANUFACTURER AND PRODUCT ANALYSIS WAS PERFORMED. GENERATOR ANALYSIS WAS PERFORMED. THE ELECTRICAL TESTS PERFORMED IN THE PRODUCT ANALYSIS LAB FOUND THAT THE GENERATOR WAS AT THE EOS = YES DISABLED CONDITION WITH THE MEMORY LOCATIONS INDICATING THAT 24.583% OF THE BATTERY HAD BEEN CONSUMED. THE BATTERY VOLTAGE WAS FOUND TO BE AT 1.629 VOLTS. THE DEVICE WAS FOUND TO BE DEPLETED, AND THEREFORE, THE SYSTEM DIAGNOSTICS AND FINAL ELECTRICAL TEST COULD NOT BE PERFORMED. A VISUAL ASSESSMENT OF THE PRINTED CIRCUIT BOARD SHOWED CONTAMINATES ON THE TRIMMED EDGE OF THE PRINTED CIRCUIT BOARD WHICH SUGGEST PROBABLE ELECTRICAL PATHS (RESISTIVE PATH) WERE ESTABLISHED BETWEEN THE COPPER EDGES ON THE TRIMMED EDGE OF THE PRINTED CIRCUIT BOARD. THIS CONTRIBUTED TO THE SUPPLY CURRENT CONDITIONS WHICH RESULTED IN INCREASED CURRENT CONSUMPTION FOR BOTH STANDBY AND PULSING MODES OF OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE SHOWED A 11-25% INDICATOR AFTER BEING IMPLANTED FOR UNDER TWO YEARS. IT WAS ALSO STATED THAT THIS DEVICE WAS ON THE LIST OF AT RISK DEVICES FOR PREMATURE BATTERY DEPLETION. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR, AND IT WAS FOUND THAT THE GENERATOR WAS LASER-ROUTED DURING THE MANUFACTURING PROCESS. LASER-ROUTING HAS BEEN SHOWN TO PRODUCE EXCESS DEBRIS ON THE CIRCUIT BOARD. THIS DEBRIS MAY LEAD TO EXCESS CURRENT DRAW FROM THE GENERATOR, WHICH CAN DEPLETE THE BATTERY PREMATURELY. DATA FROM THE PATIENT'S DEVICE WAS REVIEWED AND IT CONFIRMS THAT THE BATTERY DEPLETED MORE QUICKLY THAN EXPECTED. THE BATTERY VOLTAGE DEPLETED MORE QUICKLY COMPARED TO THE CHARGE CONSUMED (%) VALUES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959437 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 203402 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR