BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 20231522 · Received September 16, 2024

    Report

    Report Number
    1644487-2024-01175
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    May 2, 2024
    Report Date
    November 14, 2024
    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.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT PATIENT HAD A PROPHYLACTIC BATTERY REPLACEMENT. THE DEVICE HAS BEEN RECEIVED INTO PRODUCT ANALYSIS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT¿S DEVICE COULD NOT BE INTERROGATED, THAT ERROR CODE 254 WAS SEEN. PATIENT CANNOT PERCEIVE NORMAL OR MAGNET MODE STIMULATION. A GENERATOR RESET WAS PERFORMED AND LOW IMPEDANCE WAS SEEN. IT WAS SUSPECTED THAT THE REED SWITCH WAS STUCK SO RAPID MAGNET SWIPES WERE PERFORMED FOR 30 SECONDS WHICH DID NOT REGISTER OR RESULT IN SUCCESSFUL INTERROGATION. DEVICE HISTORY RECORDS WERE REVIEWED AND THE GENERATOR WAS SEEN TO PASS ALL FUNCTIONAL AND QUALITY TESTING PRIOR TO DISTRIBUTION. PROGRAMMING HISTORY WAS REVIEWED AND DETERMINED THAT THE DEVICE LIKELY HAS A STUCK CLOSED REED SWITCH. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED AND ALTHOUGH THE REED SWITCH MALFUNCTION WAS NOT REPLICATED IN THE PA LAB, THE ULTIMATE CONCLUSION OF THE ANALYSIS PROVIDED WAS THAT THE REED SWITCH BEING STUCK CLOSED WAS THE CAUSE AND CONTRIBUTING FACTOR TO THE REPORTED ALLEGATIONS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739928 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 204921 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female