BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 18579155 · Received January 25, 2024

    Report

    Report Number
    1644487-2024-00072
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    November 2, 2023
    Report Date
    September 23, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 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 WAS RECEIVED NOTING THAT THE PATIENT WAS EXPLANTED DUE TO BATTERY DEPLETION, BUT WAS NOTED THAT THE PATIENT WAS ELECTROCUTED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 0

    THE GENERATOR WAS RETURNED AND RECEIVED BY THE MANUFACTURING TO UNDERGO PRODUCT ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN AN ELECTROCUTION ACCIDENT AROUND 2 MONTHS AGO. IT WAS NOTED THAT IN THEIR RECENT CLINIC VISIT, THE PHYSICIAN FOUND THAT THE BATTERY WAS COMPLETELY DEPLETED AND NOTED IT TO POSSIBLY BE DUE TO THE ELECTROCUTION. ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT THE PATIENT COULD NOT FEEL THE MAGNET AND THAT THE DEVICE WAS NOT ABLE TO BE DETECTED DESPITE USING TWO DIFFERENT PROGRAMMING TABLETS. PATIENT IS ALSO NOTED TO BE REFERRED FOR A BATTERY REPLACEMENT DEVICE HISTORY RECORDS WERE REVIEWED FOR THE DEVICE. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WAS HP STERILIZED PRIOR TO DISTRIBUTION. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE MICROCONTROLLER WAS REMOVED FROM THE PCBA AND SENT TO TEXAS INSTRUMENTS (TI) FOR ANALYSIS. TI DECLINED THE REQUEST BECAUSE THIS FAILURE WAS IDENTICAL TO A FAILURE SEEN IN ANOTHER CASE, MFR. REPORT # 1644487-2024-00011, WHICH HAD ALREADY BEEN APPROVED FOR ANALYSIS BY TI. THE VENDOR ANALYSIS OF THE MICROCONTROLLER CONFIRMED A FAILURE WITHIN THE MICROCONTROLLER, HOWEVER IT DID NOT IDENTIFY THE SAME COMPONENT TO BE THE CAUSE OF THE FAILURE (FAILURE OF TA0). THE VENDOR ANALYSIS CONFIRMED THAT THE MCU RESET DOES OCCUR, BUT IS RANDOM AND HAS NO SPECIFIC TEMPORAL PATTERN ASSOCIATED WITH IT. THE MICROCONTROLLER WAS NOT RETURNED TO LIVANOVA FOLLOWING VENDOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190607 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205301 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male