BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 21850815 · Received April 16, 2025

    Report

    Report Number
    1644487-2025-00415
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 18, 2025
    Report Date
    January 13, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 CFR 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

    IT WAS REPORTED THAT A NEW GENERATOR WAS INTERROGATED WHILE STILL IN PACKAGING AND LOW IMPEDANCE (<600 OHMS) WAS OBSERVED. NO ERROR MESSAGES OCCURRED. A SECOND DIAGNOSTIC TEST WAS DONE WITH IMPEDANCE OVER 9000 OHMS. INTERNAL DATA FROM THE GENERATOR WAS REVIEWED. THE BASIC INTERROGATION WAS PERFORMED. AT START OF THE INTERROGATION, THE MICROCONTROLLER CHECKS THE STATE OF THE REED SWITCH AND RECORDS IT IN MEMORY. DURING THE REVIEW, IT WAS OBSERVED THAT THE REED SWITCH WAS IN THE OPEN POSITION AT THE START OF THE INTERROGATION. AS THE INTERROGATION PROGRESSED, THE DEVICE DETECTED A MAGNETIC FIELD, WHICH CAUSED THE REED SWITCH TO CLOSE SOMETIME BEFORE THE LEAD IMPEDANCE MEASUREMENT WAS TAKEN. THIS RESULTED IN A LOW IMPEDANCE ERROR. AT THE END OF THE INTERROGATION, THE MICROCONTROLLER LOGGED THE REED SWITCH AS BEING IN THE CLOSED POSITION. THIS STATUS WAS ALSO REFLECTED IN THE DECODER'S RUN STATE, WHICH INDICATED "MAGNET PRESENT." PRIOR TO THE SYSTEM DIAGNOSTICS TEST, THE REED SWITCH TRANSITIONED TO THE OPEN POSITION AND CONTINUED TO BE IN THE OPEN POSITION THROUGH OUT THE TEST. THE TEST COMPLETED WITH A HIGH IMPEDANCE ERROR, WHICH IS CONSISTENT WITH THE REED SWITCH BEING OPEN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. THERE WAS NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 0

    THE EXPLANTED GENERATOR WAS RECEIVED, AND PRODUCT ANALYSIS IS UNDERWAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THERE WAS NO MAGNET NEAR BY THE GENERATOR OR NO KNOWN MAGNETIC FIELD WHEN INTERROGATING THE DEVICE. THE DEVICE HISTORY RECORDS FOR THE GENERATOR WAS REVIEWED. THE GENERATOR PASSED FINAL FUNCTIONAL AND QUALITY SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115988 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown