BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORY PACK MODEL 502

    MDR report key: 13538582 · Received February 15, 2022

    Report

    Report Number
    1644487-2022-00158
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 20, 2022
    Report Date
    May 31, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750245
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A LIVANOVA REPRESENTATIVE IDENTIFIED THAT AN ACCESSORY PACK IN THEIR TRUNK STOCK HAD A CRACK IN THE PLASTIC AND THIS WAS DEEMED UNSTERILE. THE ACCESSORY PACK HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE ACCESSORY PACK WAS FOUND TO BE CRACKED UPON INITIAL RECEIPT BUT DURING A LATER REVIEW OF THE LIVANOVA'S REPRESENTATIVE TRUCK STOCK. IT WAS ALSO NOTED THAT THE ACCESSORY PACK WAS STORED IN A BACKPACK AND COULD'VE BEEN DAMAGED DURING THAT TIME.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED ACCESSORY PACK. DENTS AND COMPRESSED/CRUSHED APPEARANCE WERE ON THREE CORNERS OF THE OUTER TRAY. AN OPENING WAS NOTED IN THE OUTER TRAY AT ONE CORNER. CREASES WERE NOTED ON THE OUTER TRAY ALONG THREE SIDES OF THE TRAY. THE OVERALL APPEARANCE OF THE OUTER TRAY WAS MOST LIKELY RESULT OF THE TRAY BEING COMPRESSED. NO ANOMALIES WERE NOTED ON THE TYVEK SEAL OF THE OUTER TRAY. NO ANOMALIES WERE NOTED ON THE INNER TRAY OR ITS TYVEK SEAL.

    Description of Event or Problem · 0

    THE SUSPECT PRODUCT WAS RECEIVED BUT PRODUCT ANALYSIS IS STILL UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909781 ACCESSORY PACK MODEL 502 ACCESSORY PACK LYJ LIVANOVA USA, INC. 502 4232409 05425025750245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown