BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 5884783 · Received August 17, 2016

    Report

    Report Number
    6000034-2016-01689
    Event Type
    Injury
    Date Received
    August 17, 2016
    Report Date
    September 26, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE AND INITIAL IMPLANTATION DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT , THIS REPORT IS FILED ON AUGUST 18, 2016. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS: 'BIM400 IMPLANT MAGNET', NOT 'FLANGE FIXTURE AND ABUTMENT' AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS: 'COCHLEAR BAHA ATTRACT SYSTEM', NOT 'LXB' AS PREVIOUSLY REPORTED. THE CORRECT MODEL # IS: 93550, NOT 'BI300' AS PREVIOUSLY REPORTED. THE CORRECT CATALOG # IS: 93550, NOT '92129' AS PREVIOUSLY REPORTED. THE CORRECT 510(K) NUMBER IS: K131240, NOT 'K100360' AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AND PAIN AT IMPLANT SITE, HOWEVER THE ISSUE DID NOT RESOLVE. SUBSEQUENTLY THE IMPLANT MAGNET WAS EXPLANTED. CLINICAL MANAGEMENT OF THE PATIENT IS ONGOING. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533945 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention