BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 17051560 · Received June 2, 2023

    Report

    Report Number
    1644487-2023-00710
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    July 15, 2021
    Report Date
    July 21, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750115
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT HIGH LEAD IMPEDANCE WAS NEVER SEEN FOR THIS PATIENT IN CLINIC AND THE PRE-OP IMPEDANCES WERE WITHIN NORMAL LIMITS. ALSO THE PATIENT HAS BEEN SEEN IN CLINIC SINCE GETTING THEIR NEW GENERATOR IMPLANTED AND NO IMPEDANCE ISSUES HAVE BEEN SEEN. INTERNAL DATA FROM THE M106 AND M1000 GENERATORS WERE PROVIDED AND REVIEWED AND THERE WERE NO IMPEDANCE ISSUES FOUND IN THE DATA.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A BATTERY REPLACEMENT DUE TO BATTERY DEPLETION AND THE EXPLANTED GENERATOR WAS RETURNED AND UNDERWENT PRODUCT ANALYSIS. AN INTERROGATION, A SYSTEM DIAGNOSTIC TEST, AN OUTPUT WAVEFORM MEASUREMENT, A VBAT CALCULATION (SHOWS AN IFI=NO CONDITION), AND A BATTERY LIFE CALCULATION WERE PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647686 LEAD MODEL 303 LEAD LYJ LIVANOVA USA, INC. 303-20 203193 05425025750115

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female