BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 19193074 · Received April 26, 2024

    Report

    Report Number
    1644487-2024-00482
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 31, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    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 REPORTED THAT WHEN TRYING TO INTERROGATE THE PATIENT, A "CURRENT NOT DELIVERED" ERROR MESSAGE WAS SEEN. IMPEDANCE WAS NORMAL, BUT THEY WERE UNABLE TO PERFORM A SYSTEM DIAGNOSTIC TEST DUE TO THE ERROR MESSAGE AND CODE 254. IT WAS NOTED THAT THE PATIENT FREQUENTLY SWIPES THEIR MAGNET EVERY DAY. THE PATIENT IS EXPERIENCING AN INCREASE IN SEIZURES. AN ADVANCED INTERROGATION WAS PERFORMED, SHOWING THE LAST MAGNET SWIPE WAS 02/15/24. RAPID MAGNET SWIPES WERE DONE TO TRY AND "UNSTICK" THE REED SWITCH, BUT DID NOT REGISTER ON THE PROGRAMMER. THEY LATER ATTEMPTED A GENERATOR RESET, BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS SCHEDULED FOR A BATTERY REPLACEMENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PATIENT LATER HAD BATTERY REPLACEMENT. EXPLANTED DEVICE WAS RETURNED AND RECEIVED BY MANUFACTURER TO UNDERGO PRODUCT ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886423 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7240 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Other