BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 12304513 · Received August 10, 2021

    Report

    Report Number
    1644487-2021-01099
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    June 17, 2021
    Report Date
    September 9, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    F10. MEDICAL DEVICE - CORRECTION - CODE A072102 SHOULD HAVE BEEN INCLUDED IN THE INITIAL MDR. H6. INVESTIGATION FINDINGS - CORRECTION - CODE C0208 SHOULD HAVE BEEN USED IN REPLACE OF CODE C0203 IN THE INITIAL MDR. H6. INVESTIGATION CONCLUSIONS - CORRECTION - CODE D02 SHOULD HAVE BEEN USED IN REPLACE OF CODE D14 IN THE INITIAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FULL REVISION DUE TO LOW IMPEDANCE. THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198552 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 202005

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR