BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 18766432 · Received February 23, 2024

    Report

    Report Number
    1644487-2024-00182
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 30, 2024
    Report Date
    April 23, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. AN INTERROGATION AND SYSTEM DIAGNOSTIC TESTS WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND DID NOT PERFORM AS EXPECTED. A MAGNET SWIPE WAS DONE TO ACTIVATE THE MAGNET CURRENT TO CAPTURE THE DUTS RAMPS, SO ALL DUTS RAMPS COULD BE CAPTURED ON THE FIRST PAGE. HOWEVER, THE REED SWITCH APPEARS TO HAVE STUCK CLOSED AS THE OUTPUT SIGNAL DID RETURN AFTER THE MAGNET WAS APPLIED. TAPPED ON THE DUT FOR THE FIRST HOUR, BUT THE OUTPUT SIGNAL DID NOT RETURN. IT APPEARS THE REED SWITCH RELEASED ON ITS OWN AS THE OUTPUT SIGNAL RETURNED APPROXIMATELY 5 HOURS AFTER THE 24-HOUR MONITORING PERIOD HAD BEGUN. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS AN IFI=NO CONDITION) WAS PERFORMED. OTHER THAN THE REED SWITCH STUCK CLOSED CONDITION DURING THE OUTPUT SIGNAL MONITORING PERIOD, THE DUT PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DEVICE HISTORY RECORDS FOR THE GENERATOR WAS PERFORMED. THE GENERATOR PASSED FINAL FUNCTIONAL AND QUALITY SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN TO HAVE LOW IMPEDANCE AND WAS REFERRED FOR SURGERY. THE PATIENT UNDERWENT SURGERY AND ONLY THEIR GENERATOR WAS REPLACED. THE LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS AFTER THE GENERATOR WAS REPLACED. ALTHOUGH THE IMPEDANCE RESOLVED WITH ONLY THE GENERATOR BEING CHANGED, THERE IS NOT ENOUGH EVIDENCE AT THIS TIME TO RULE OUT A LEAD ISSUE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE WITH THE LEAD. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114233 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7651 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male