BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 4969258 · Received August 5, 2015

    Report

    Report Number
    6000034-2015-01569
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 6, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT BRAND NAME IS: BIM400 IMPLANT MAGNET NOT BAHA ATTRACT SYSTEM AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA ATTRACT SYSTEM, NOT LXB, PRODUCT CODE: LXB AS PREVIOUSLY REPORTED. THE CORRECT CATALOG NUMBER IS 93550 NOT 92129 AS PREVIOUSLY REPORTED. REGISTRATION NUMBER (B)(4). EXEMPTION NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (B)(6), 2015 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512781 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550 152914

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention