BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 10587493 · Received September 25, 2020

    Report

    Report Number
    1644487-2020-01297
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    November 6, 2019
    Report Date
    October 12, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    F10 MEDICAL DEVICE CODE, CORRECTED DATA: SUPPLEMENTAL REPORT #01 INADVERTENTLY DID NOT INCLUDE CODE ¿A072202¿ FOR LOW IMPEDANCE.

    Additional Manufacturer Narrative · 0

    F10 HEALTH EFFECT IMPACT CODE, CORRECTED DATA: SUPPLEMENTAL REPORT #03 INADVERTENTLY LISTED CODE ¿F1903¿ INSTEAD OF ¿F1905¿.

    Additional Manufacturer Narrative · 0

    A2 AGE AT TIME OF EVENT, CORRECTED DATA: SUPPLEMENTAL REPORT #04 SHOULD HAVE UPDATED PATIENT AGE BASED ON UPDATED EVENT DATE. B3 DATE OF EVENT, CORRECTED DATA: SUPPLEMENTAL REPORT #04 SHOULD HAVE UPDATED EVENT DATE BASED ON IMPEDANCE CHANGE HISTORY.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT FULL REVISION SURGERY DUE TO IMPEDANCE ISSUES. ON THE DATE OF SURGERY, THE PRE-OPERATIVE DIAGNOSTICS SHOWED OK IMPEDANCE WHEN THE PATIENT'S HEAD WAS FACING STRAIGHT, BUT WHEN THE PATIENT WOULD TURN HER HEAD THE IMPEDANCE WOULD SHOW AS LOW. THE SUSPECT DEVICE WAS RETURNED AND RECEIVED FOR ANALYSIS. PRODUCT ANALYSIS IS PENDING COMPLETION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    GENERATOR PRODUCT ANALYSIS (PA) WAS COMPLETED. THE GENERATOR OUTPUT WAS MONITORED FOR 62;24 HOURS IN A SIMULATED BODY TEMPERATURE ENVIRONMENT, AND THERE WAS NO VARIATION IN THE DELIVERED OUTPUT CURRENT DURING THE MONITORING PERIOD. AS-RECEIVED, THE GENERATOR WAS FOUND TO BE AT END OF SERVICE (EOS) = YES. OTHER THAN THE EOS = YES CONDITION, THERE WERE NO ADDITIONAL PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE 25% CHANGE IN IMPEDANCE HISTORY WAS REVIEWED, AND A HISTORY OF FLUCTUATING HIGH AND LOW IMPEDANCE WERE NOTED. ANALYSIS HAS NOT BEEN COMPLETED ON THE SUSPECT DEVICE TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT'S LEAD IMPEDANCE IS NOW LOW, AND THE PATIENT HAS BEEN EXPERIENCING VOCAL CORD PARALYSIS (VCP) SINCE THE LEAD MALFUNCTION WAS FIRST REPORTED. THE VNS WAS DISABLED AND THE PATIENT WAS STILL EXPERIENCING VCP. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 0

    LEAD PRODUCT ANALYSIS (PA) WAS COMPLETED. THE REPORTED HIGH AND LOW IMPEDANCE ALLEGATIONS WERE NOT DUPLICATED IN THE PA LAB. THE LEAD WAS RETURNED IN ONE PORTION. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION SHOWED NO DISCONTINUITIES OR SHORT CIRCUITS. IT WAS NOTED THAT THE LEAD BODY AND COILS APPEARED TWISTED AND WAVY NEAR THE CUT END OF THE LEAD. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. THE DRIED REMNANTS OF BODY FLUIDS WERE FOUND IN BOTH THE INNER AND OUTER TUBING; HOWEVER, THE ONLY OBVIOUS LEAKAGE PATH WAS THE CUT END. PORTIONS OF THE LEAD APPEARED COMPRESSED, AND THERE WERE ABRASIONS ON THE INSULATION BUT NO OPENINGS. SETSCREW MARKS ON THE CONNECTOR PIN INDICATE THAT AT ONE TIME GOOD MECHANICAL AND ELECTRICAL CONNECTION EXISTED BETWEEN THE GENERATOR AND LEAD. NOTE THAT SINCE A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S VNS SHOWED HIGH IMPEDANCE AT A FOLLOW UP VISIT. DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECT LEAD. THE LEAD PASSED ALL QUALITY CONTROL MEASURES PRIOR TO DISTRIBUTION, AND NO UNRESOLVED NONCONFORMANCES WERE FOUND. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054892 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 204998 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability