BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 6084549 · Received November 7, 2016

    Report

    Report Number
    6000034-2016-02225
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 27, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON NOVEMBER 08, 2016. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE; SUBSEQUENTLY THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016, TO REMOVE AN INTERNAL MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732792 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention