BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 18503046 · Received January 12, 2024

    Report

    Report Number
    1644487-2024-00042
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 18, 2023
    Report Date
    February 9, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT NOTE THAT LOW IMPEDANCE WAS OBSERVED ON THE NEW GENERATOR D SUSPECT MEDICAL DEVICE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY REPORTED THE SUSPECT DEVICE AS THE GENERATOR INSTEAD OF THE LEAD F10 ADVERSE EVENT PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CODE 'A072202', 'A072102' AND 'G02025' H4 DEVICE MANUFACTURE DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED THE WRONG DATE H6 ADVERSE EVENT PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY CODED B17 INSTEAD OF B20 FOR TYPE OF INVESTIGATION, CODED C0203 INSTEAD OF C0208 FOR INVESTIGATION FINDINGS AND CODED D14 INSTEAD OF D02 FOR INVESTIGATION CONCLUSIONS.

    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

    ADDITIONAL INFORMATION RECEIVED NOTING THAT LOW IMPEDANCE WAS OBSERVED ON THE PATIENT'S NEWLY IMPLANTED GENERATOR. INTERNAL DATA FROM THE EXPLANTED GENERATOR WAS RECEIVED AND REVIEWED. FROM THE REVIEW, THERE WAS NO EVIDENCE THAT HIGH IMPEDANCE WAS EVER OBSERVED JUST LOW IMPEDANCE. THE REP WHO COVERED THE CASE INADVERTENTLY MADE A MISTAKE AND REPORTED HIGH IMPEDANCE INSTEAD OF LOW IMPEDANCE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE WITH THE LEAD. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IMPLANT CARD RECEIVED NOTING THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT DUE TO HIGH IMPEDANCE. THE FINAL IMPEDANCE WITH THE NEW GENERATOR WAS NOTED TO BE GOOD. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693883 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 202115 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male