BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 15696745 · Received October 29, 2022

    Report

    Report Number
    1644487-2022-01343
    Event Type
    Malfunction
    Date Received
    October 29, 2022
    Date of Event
    October 3, 2022
    Report Date
    March 17, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 INTERROGATED, THE PATIENTS GENERATOR WAS SHOWING A LOW OUTPUT CURRENT ERROR MESSAGE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE GENERATOR DATA WAS REVIEWED IN WHICH THE GENERATOR WAS SEEN TO BE IN A STIM INHIBITED STATE. THIS WOULD MEAN THAT THE PATIENT'S DEVICE WAS BEING INTERROGATED WITH THE MAGNET TAPED OVER THE DEVICE (FOR THE ENTIRE CLINIC VISIT). OR THIS IS MORE LIKELY AN ISSUE INVOLVING THE REED SWITCH BEING STUCK IN A CLOSED STATE (WHICH WOULD REPLICATE A MAGNET HOLD). ADDITIONALLY, NO SYSTEM DIAGNOSTICS EVENTS ARE POPULATED IN THE LINE ABOVE THE ADVANCED INTERROGATION. THIS LACK OF SYSTEM DIAGNOSTIC EVENT FURTHER SUPPORTS THE LIKELIHOOD OF A REED SWITCH FAILURE. THE DATA INDICATED THAT THE MAX STIMULATION DELIVERED FROM THE LAST RECORDED STIMULATION WAS .5 MA. THIS DOES NOT ALIGN WITH THE PROGRAMMED 2.25 MA. THIS SUPPORTS THE CLAIM OF A LOW OUTPUT CURRENT. THE LAST RECORDED IMPEDANCE VALUE WAS TAKEN ON (B)(6) 2022. THIS WAS THE LAST TIME A 24 HOUR IMPEDANCE CHECK WAS TAKEN BY THE GENERATOR. THIS IS NOT EXPECTED AND INDICATIVE OF A POTENTIAL REED SWITCH ISSUE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692977 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7101 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male