BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 7783897 · Received August 15, 2018

    Report

    Report Number
    1644487-2018-01400
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    May 28, 2015
    Report Date
    February 12, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750054
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN BELIEVED THAT A PATIENT'S DEVICE WAS DEPLETING FASTER THAN EXPECTED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED USING A PROCESS THAT MAY HAVE CONTRIBUTED TO THE PREMATURE BATTERY DEPLETION. THE DEVICE MET ALL SPECIFICATIONS FOR RELEASE PRIOR TO DISTRIBUTION. PROGRAMMING HISTORY WAS REVIEWED FOR THE PATIENT'S DEVICE. THE 25% BATTERY REMAINING INDICATOR WAS FIRST OBSERVED 2 YEARS AFTER IMPLANT, ALTHOUGH ONLY 28% OF THE BATTERY CAPACITY HAD BEEN CONSUMED. THIS DISCREPANCY INDICATED THAT THE BATTERY WAS DEPLETING FASTER THAN EXPECTED. IMPEDANCE WAS WITHIN THE NORMAL LIMITS THROUGHOUT THE AVAILABLE PROGRAMMING HISTORY. THERE WAS NO EVIDENCE THAT AN ELECTROCAUTERY TOOL CAME INTO CONTACT WITH THE DEVICE AT IMPLANT. IT APPEARED LIKELY THAT THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS RELATED TO THE MANUFACTURING PROCESS OF THE GENERATOR. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REPLACEMENT SURGERY. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Description of Event or Problem · 1

    GENERATOR WAS RECEIVED FOR ANALYSIS. THE REPORTED ALLEGATIONS OF ¿PREMATURE END OF LIFE (EOL)¿, ¿DEVICE FAILURE¿, WAS DUPLICATED IN THE LAB. A VISUAL ASSESSMENT ON THE PCBA SHOWED CONTAMINATES ON THE TRIMMED EDGE OF THE PCBA. THE BATTERY WAS REMOVED. THE PCBA WAS SUBJECTED TO A POSTBURN ELECTRICAL TEST. RESULTS SHOW THAT THE PCBA FAILED SEVERAL ELECTRICAL TESTS: SUPPLY CURRENT 2MA/NORMAL, SUPPLY CURRENT OFF, SUPPLY CURRENT OFF SENSE, AND TRIM DIAGONCURRENT. FINE GRIT SANDPAPER WAS USED FOR THE REMOVAL OF THE OBSERVED CONTAMINATES FROM THE TRIMMED EDGE OF THE PCBA. AFTER THE TRIMMED EDGE OF THE PCBA WAS CLEANED, A POSTBURN ELECTRICAL TEST WAS PERFORMED AGAIN AND THE PCBA PASSED THE PREVIOUSLY FAILED TESTS. BASED ON THESE RESULTS, THE CONTAMINATION THAT WAS OBSERVED ON THE TRIMMED EDGE OF THE PCBA SUGGEST PROBABLE ELECTRICAL PATHS (RESISTIVE PATH) WERE ESTABLISHED BETWEEN THE COPPER EDGES ON THE TRIMMED EDGE OF THE PCBA, WHICH CONTRIBUTED TO THE SUPPLY CURRENT CONDITIONS. REMAINING RESIDUAL MATERIAL ON THE PCBA EDGE AFTER THE ¿TEST TAB¿ REMOVAL MANUFACTURING PROCESS RESULTED IN INCREASED CURRENT CONSUMPTION (OUT OF SPECIATION) FOR BOTH STANDBY AND PULSING MODES OF OPERATION, AND MAY HAVE BEEN THE CONTRIBUTING FACTOR FOR THE REPORTED ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628449 PULSE GEN MODEL 105 GENERATOR LYJ LIVANOVA USA, INC. 105 203380 05425025750054

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR