BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 5485175 · Received March 7, 2016

    Report

    Report Number
    6000034-2016-00520
    Event Type
    Injury
    Date Received
    March 7, 2016
    Report Date
    June 9, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED, (B)(6) 2016. THE IMPLANTED DEVICE REMAINS.

    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 FILED ON JULY 06, 2017. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT TWO REVISION SURGERIES (DATES NOT REPORTED) TO EXCISE EXCESS TISSUE FROM THE IMPLANT SITE. THE PATIENT ALSO DEVELOPED AN INFECTION THAT WAS TREATED WITH ANTIBIOTICS (DATE AND DURATION NOT REPORTED). SUBSEQUENTLY ON (B)(6) 2015 THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO HAVE THE INTERNAL MAGNET REMOVED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139673 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550 93882

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention