BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 12135368 · Received July 8, 2021

    Report

    Report Number
    1644487-2021-00926
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    September 9, 2016
    Report Date
    August 3, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    F10. - CORRECTION - A040101 SHOULD HAVE BEEN USED IN INITIAL MDR. H6. INVESTIGATION FINDINGS - CORRECTION - C070603 SHOULD HAVE BEEN USED IN INITIAL MDR. H6. INVESTIGATION CONCLUSIONS - CORRECTION - D02 SHOULD HAVE BEEN USED IN INITIAL MDR.

    Description of Event or Problem · 0

    DURING FOLLOW UP, IT WAS NOTED THAT THE PROVIDER HAD OBSERVED THE HIGH IMPEDANCE AND IS AWARE. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    PATIENT HAD A GENERATOR REPLACEMENT OCCUR. THE GENERATOR WAS RETURNED AND PRODUCT ANALYSIS WAS PERFORMED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE DOWNLOADED DATA SHOWED THAT HIGH IMPEDANCE MAY POSSIBLY HAVE OCCURRED WHILE IMPLANTED, RESULTING IN A ¿VBOOST¿ COMPLIANCE VOLTAGE CONDITION. IN THE DATA DUMP, IT WAS NOTED THAT THE LAST 25% CHANGE IN IMPEDANCE WAS FROM A GOOD IMPEDANCE VALUE (1690 OHMS) TO A HIGH IMPEDANCE VALUE (8595 OHMS) ON (B)(6) 2016, DURING IMPLANT AND DID NOT CORRELATE WITH THE REPLACEMENT SURGERY. NO IMPEDANCE ISSUES WERE OBSERVED DURING REPLACEMENT SURGERY. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031848 LEAD MODEL 303 LEAD LYJ LIVANOVA USA, INC. 303-20 2696

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR