BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000-D

    MDR report key: 19004338 · Received March 29, 2024

    Report

    Report Number
    1644487-2024-00360
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    March 5, 2024
    Report Date
    June 7, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750528
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION FINDINGS; CORRECTED DATA; INITIAL MDR INADVERTENTLY ENTERED INCORRECT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GENERATOR INTENDED TO BE IMPLANTED IN THE PATIENT WAS UNABLE TO BE INTERROGATED. TROUBLESHOOTING WAS ATTEMPTED, EFFORTS WERE MADE TO REDUCE EMI, HOWEVER THE GENERATOR WAS STILL UNABLE TO BE INTERROGATED AFTER SEVERAL ATTEMPTS. THE SURGEON OPTED TO IMPLANT A DIFFERENT GENERATOR WHICH WAS IMPLANTED AND SUCCESSFULLY INTERROGATED. DEVICE HISTORY RECORDS WERE REVIEWED AND THE DEVICE WAS SEEN TO PASS ALL FUNCTIONAL AND QUALITY TESTING PRIOR TO DISTRIBUTION. THE DEVICE HAS BEEN RECEIVED INTO PRODUCT ANALYSIS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED AND IT WAS DISCOVERED THAT THE DEVICE WAS LIKELY EXPOSED TO ELECTROCAUTERY CAUSING A PREMATURE DEPLETION OF THE BATTERY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593868 PULSE GEN MODEL 1000-D GENERATOR LYJ LIVANOVA USA, INC. 1000-D 853 05425025750528

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male