BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 10258267 · Received July 10, 2020

    Report

    Report Number
    1644487-2020-00941
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 16, 2020
    Report Date
    October 3, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT PATIENT HAD A FULL REVISION DUE TO HIGH IMPEDANCE. AFTER FULL REVISION, IMPEDANCE WAS WITHIN NORMAL LIMITS. PRODUCT RETURN IS NOT POSSIBLE AS FACILITY ALWAYS DISCARDS PRODUCTS AFTER EXPLANT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    PATIENT WAS REFERRED FOR SURGERY DUE TO LOW BATTERY AND POSSIBLE HIGH IMPEDANCE. INFORMATION WAS RECEIVED FROM THE SURGEONS OFFICE NOTING THAT THEY WERE UNSURE REGARDING THE REASON FOR THE REFERRAL AND DID NOT KNOW ABOUT THE HLI. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723917 LEAD MODEL 302 LEAD LYJ LIVANOVA USA, INC. 302-20 7763

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male