BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 18632851 · Received February 2, 2024

    Report

    Report Number
    1644487-2024-00099
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    November 17, 2023
    Report Date
    March 8, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE GENERATOR WAS REPLACED DUE TO THIS LOW IMPEDANCE CONDITION. REVIEW OF THE GENERATOR'S INTERNAL DATA INDICATED THAT THE LIKELY CAUSE OF THE ISSUE SURROUND SURROUNDING THIS DEVICE IS RELATED TO A REED SWITCH ISSUE. THE EXPLANTED GENERATOR HAS NOT BEEN RETURNED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERROGATION, OUTPUT CURRENT LOW AND THAT ERROR CODE 254 WAS SEEN. TROUBLESHOOTING OF DIFFERENT PROGRAMMING SYSTEM, WAND RESET, WAND REPOSITIONING, AND CONFIRMATION OF NO LARGE EMI SOURCES IN THE AREA WERE PERFORMED. IT WAS NOTED THAT THE PATIENT UNDERWENT SURGERY, NOT RELATED TO VNS, AND THAT ELECTROCAUTERY WAS USED SOMETIME PREVIOUSLY. MULTIPLE MAGNET SWIPES WERE PERFORMED IN RAPID SUCCESSION FOR 30 SECONDS AND THE GENERATOR WAS ABLE TO BE INTERROGATED WITH OUTPUT CURRENTLY STILL LOW BUT WITHIN NORMAL LIMITS IMPEDANCE VALUE. EVENT/TRENDS TAB WAS NOTED TO NOT DISPLAY CONFIRMED MAGNET SWIPES PAST A CERTAIN DATE. GENERATOR RESET WAS PERFORMED WHICH RESULTED IN AN ERROR CODE 4 AND LOW IMPEDANCE BEING SEEN. ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT THE PATIENT IS SCHEDULED FOR A BATTERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255779 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7063 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female