BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 20241353 · Received September 17, 2024

    Report

    Report Number
    1644487-2024-01174
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 19, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT INADVERTENTLY REPORTED PATIENT AGE AS 24 YEARS INSTEAD OF 23 YEARS.

    Description of Event or Problem · 0

    THE SUSPECT DEVICE WAS RECEIVED BY THE MANUFACTURER AND IS AWAITING COMPLETION OF PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A GENERATOR REPLACEMENT WHERE LOW IMPEDANCE WAS SEEN IN PRE-OP. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE SUSPECT DEVICE. AN INTERROGATION AND SYSTEM DIAGNOSTIC TEST WERE PERFORMED AND THE DEVICE WAS MONITORED FOR MORE THAN 24 HOURS BUT FAILED THE 'END OF TEST' TESTS FOR A SUSPECTED REED SWITCH CONDITION. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS AN IFI=NO CONDITION) WAS PERFORMED. THE DEVICE DID NOT PERFORM ACCORDING TO SPECIFICATION REQUIREMENTS AND THE FET SHOWS NO OUTPUT SIGNALING, SUGGESTING THE REED SWITCH WAS STUCK CLOSED. THE REED SWITCH STUCK CLOSED WAS NOT REPLICATED AFTER THE DUT WAS CUT OPEN AND THE CAUSE WAS NOT DETERMINED. PRODUCT ANALYSIS WORKSHEET WAS REVIEWED AND SHOWED NO ANOMALIES. WANDCOMM DATA WAS REVIEWED AND SHOWED NO ANOMALIES. DATA DUMP WAS REVIEWED AND THE LAST IMPEDANCE CHANGE OCCURRED ON (B)(6) 2024 FROM 23933 OHMS TO 23920 OHMS ON (B)(6) 2024. LOW IMPEDANCE WAS SEEN ON SEVERAL DATES DURING IMPLANT; HOWEVER, THIS IS A SYMPTOM RELATED TO THE REED SWITCH CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON INTERROGATION, MAGNET SWIPES WERE NOT BEING RECORDED, THE LAST RECORD BEING FROM MAY. MULTIPLE MAGNET SWIPES WERE PERFORMED WHILE IN CLINIC AND THE DEVICE WAS RE-INTERROGATED, WHERE ERROR CODE 254 WAS THEN SEEN BUT RESOLVED AFTER RE-INTERROGATING. A GENERATOR RESET WAS PERFORMED AND LOW IMPEDANCE WAS SEEN AFTER. THE GENERATOR WAS REPROGRAMMED TO 3 MA AND MAGNET FUNCTION WAS CHECKED AGAIN WITH NO RESOLUTION. INTERNAL GENERATOR DATA WAS RECEIVED AND REVIEWED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO KNOWN RELEVANT 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
    2521555 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7649 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female