BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 15245570 · Received August 17, 2022

    Report

    Report Number
    1644487-2022-00997
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 25, 2022
    Report Date
    October 14, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750115
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT PATIENT HAD HIGH IMPEDANCE. X-RAYS WERE TAKEN NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY IMAGINING FACILITY THAT THE X-RAYS LOOKED "NORMAL" NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 0

    AP AND LATERAL CHEST X-RAYS WERE REVIEWED. THE PINS COULD NOT BE EASILY VISUALIZED TO BE FULLY INSERTED DUE TO THE ANGLE AT WHICH THE X-RAY WAS TAKEN; HOWEVER, BASED ON THE BACK OF END OF THE PIN, IT CAN BE CONCLUDED THAT THE PIN IS LIKELY FULLY INSERTED. BASED ON THE X-RAYS RECEIVED, THE CAUSE OF THE HIGH IMPEDANCE IS UNKNOWN BASED ON THE IMAGES PROVIDED. THE VISIBLE PORTIONS OF THE DEVICE SHOWED NO ANOMALIES; HOWEVER, ANY FRACTURES OR MICROFRACTURES ON THE PORTIONS OF THE LEAD THAT WERE NOT VISIBLE CANNOT BE RULED OUT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154342 LEAD MODEL 303 LEAD LYJ LIVANOVA USA, INC. 303-20 205006 05425025750115

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female