BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 17281487 · Received July 7, 2023

    Report

    Report Number
    1644487-2023-00881
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 13, 2023
    Report Date
    August 11, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10. MEDICAL DEVICE PROBLEM CODE, INITIAL REPORT: INADVERTENTLY USED WRONG CODE INSTEAD OF A072201. H6. INVESTIGATION FINDINGS, INITIAL REPORT: INADVERTENTLY USED WRONG CODE INSTEAD OF C0203 H6. INVESTIGATION CONCLUSIONS, INITIAL REPORT: INADVERTENTLY USED WRONG CODE INSTEAD OF D14.

    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 LATER REPORTED THAT THE EXPLANTED LEAD WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A BATTERY REPLACEMENT DUE TO BATTERY DEPLETION. THEIR BATTERY WAS UNABLE TO CHECK IMPEDANCE PRIOR TO REPLACEMENT SINCE IT WAS DEPLETED. ONCE A NEW GENERATOR WAS IMPLANTED, HIGH IMPEDANCE WAS SEEN. THE LEAD WAS ALSO REPLACED, AND IMPEDANCE WAS WITHIN NORMAL LIMITS. SINCE THE ORIGINAL BATTERY WAS DEPLETED AND UNABLE TO BE INTERROGATED, IT IS LIKELY THAT THE HIGH IMPEDANCE WOULD HAVE BEEN SEEN ON THIS GENERATOR TOO. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. SUSPECT DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055443 LEAD MODEL UNKNOWN LEAD LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male