BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 14641163 · Received June 9, 2022

    Report

    Report Number
    6000034-2022-01688
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 20, 2022
    Report Date
    May 20, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JUNE 09, 2022.

    Description of Event or Problem · 0

    PER THE AUDIOLOGIST, THE INTERNAL MAGNET WAS EXPLANTED ON (B)(6) 2022, DUE TO PAIN AND NON-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156001 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention