BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 18790178 · Received February 27, 2024

    Report

    Report Number
    1644487-2024-00213
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    January 8, 2024
    Report Date
    April 22, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 RECEIVED NOTING THAT THE PATIENT HAS BEEN SWIPING THEIR MAGNET BUT NO MAGNET SWIPE TIMESTAMPS WERE SEEN UPON INTERROGATION OF THE DEVICE. THE PATIENT THEN LATER UNDERWENT SURGERY TO HAVE THEIR GENERATOR REPLACED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE SUSPECT DEVICE WAS MISPLACED AND IS NO LONGER AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    PATIENT PRESENTS INTO CLINIC WITH REPORTS OF DECREASED PERCEPTION OF STIMULATION AND AN INCREASE IN SEIZURES. UPON INTERROGATION IT WAS NOTED THAT LOW OUTPUT CURRENT WAS OBSERVED WITH IMPEDANCE VALUE BEING OK. A SYSTEM DIAGNOSTICS WAS NOTED TO BE ATTEMPTED BUT FAILED WITH ERROR CODE 128 AND 254. TROUBLESHOOTING WAS PERFORMED IN DECREASING EMI, WAND POSITIONING, AND WAND/TABLET RESET WHICH DID NOT RESOLVE THE ISSUE. MAGNET WAS SWIPED CONSECUTIVELY AND RAPIDLY FOR 20-30 SECONDS WHICH ALSO DID NOT RESOLVE THE ISSUE. EVENTS AND TRENDS NOTED THAT THE LAST MAGNET SWIPES THAT WERE RECORDED WERE ON JANUARY 8 AND NO SWIPES THAT WERE MADE TODAY WERE RECORDED. GENERATOR RESET WAS PERFORMED WITH AN INITIAL ERROR CODE 4 (DUE TO THE GENERATOR RESET PERFORMED) AND LOW IMPEDANCE WAS SEEN. INTERNAL GENERATOR DATA WAS REVIEWED AND APPEARS THAT THE CAUSE OF THIS ISSUE IS A POTENTIAL REED SWITCH BEING STUCK. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111169 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 206085 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female