BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 5217390 · Received November 11, 2015

    Report

    Report Number
    6000034-2015-02263
    Event Type
    Injury
    Date Received
    November 11, 2015
    Report Date
    February 1, 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
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS: BIM400 IMPLANT MAGNET, NOT ATTRACT SYSTEM AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA ATTRACT SYSTEM NOT LXB: PRODUCT CODE, PRODUCT CODE: LXB AS PREVIOUSLY REPORTED. THIS REPORT IS SUBMITTED ON JULY 05, 2017. (B)(4).

    Additional Manufacturer Narrative · 1

    THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. SUBSEQUENTLY ON (B)(6) 2015 THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE INTERNAL MAGNET REMOVED AND AN ABUTMENT PLACED. AS OF REPORT ON (B)(6) 2015 THE PATIENT WAS LAST SEEN THE WEEK OF (B)(6) 2015 AND THE IMPLANTED SITE WAS HEALED WITH NO SIGNS OF INFECTION. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747288 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550 93882

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention