BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 8103

    MDR report key: 16353741 · Received February 10, 2023

    Report

    Report Number
    1644487-2023-00163
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    December 28, 2022
    Report Date
    December 22, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    UDI-DI
    05425025750504
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 LIVANOVAS 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

    PRODUCT ANALYSIS HAS BEEN COMPLETED. A SYSTEM DIAGNOSTICS WAS LATER RAN ON 4/24 SHOWING 75-100% BATTERY AND VBAT CALCULATED 2.976V. THIS INDICATES THE BATTERY VOLTAGE HAS REBOUNDED ABOVE THE 25% INDICATOR AND MEETS THE LIMITED INVESTIGATION CRITERIA FOR A HISTORICAL DATA ANALYSIS INVESTIGATION. THE INVESTIGATION LOOKED INTO BATTERY STATUS INDICATORS OF 25% THAT WERE RECEIVED SOONER THAN EXPECTED AND LATER RETURNED TO 100% WITHOUT ANY SIGNIFICANT PROGRAMMING CHANGES. THE INVESTIGATION DETERMINED THAT THE BEHAVIOR WAS LIKELY RELATED TO AN INCREASED DURATION OF THE HIGH BATTERY IMPEDANCE EXPERIENCED BY BATTERIES DURING THE BEGINNING OF LIFE (BOL). THE ROOT CAUSE OF THE PREMATURE BATTERY DEPLETION EVENT IS MOST LIKELY RELATED TO BOL BATTERY IMPEDANCE WHICH IS PART OF THE DEVICE DESIGN, NO DEVICE FAILURE HAS OCCURRED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A BATTERY REPLACEMENT. THE EXPLANTED DEVICE HAS BEEN RECEIVED INTO PRODUCT ANALYSIS WHICH IS UNDERWAY BUT NOT YET COMPLETED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS BATTERY REACHED 25% INDICATOR PREMATURELY. THE DEVICE SHOWED 18-25% BATTERY LIFE REMAINING AFTER 7 MONTHS OF THERAPY. SETTINGS AND DIAGNOSTICS FROM TWO DATES WERE PROVIDED. IT WAS ALSO REPORTED THAT THEY ARE SEEKING REPLACEMENT. DEVICE HISTORY RECORDS WERE REVIEWED. THE DEVICE PASSED ALL FUNCTIONAL AND QUALITY TESTING PRIOR TO DISTRIBUTION. NO RECENT SURGERIES, ELECTROCAUTERY, OR UNUSUAL EVENTS OCCURRED THAT COULD HAVE CONTRIBUTED TO THE EVENT. TABLET DATA WAS RECEIVED AND A DECODER REVIEW WAS COMPLETED. THERE IS SUSPICION THAT THE VOLTAGE WILL REBOUND ABOVE THE 2.85V 25% INDICATOR THRESHOLD BUT NOT YET CONFIRMED. FOLLOW UP HAS BEEN INITIATED FOR UPDATED SYSTEM DIAGNOSTICS. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066398 PULSE GEN MODEL 8103 GENERATOR MUZ LIVANOVA USA, INC. 8103 6995 05425025750504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown