BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 4974050 · Received August 5, 2015

    Report

    Report Number
    6000034-2015-01528
    Event Type
    Injury
    Date Received
    August 5, 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
    MT, 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: LXB AS PREVIOUSLY REPORTED. THIS REPORT IS FILED ON JULY 05, 2017. (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 TO HAVE THE INTERNAL MAGNET REMOVED AND AN ABUTMENT PLACED. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED FEBRUARY 10, 2016.

    Additional Manufacturer Narrative · 1

    THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A HEMATOMA/SEROMA AT THE IMPLANT SITE. IT WAS REPORTEDLY ASPIRATED TWO TIMES (DATES NOT REPORTED). AS OF REPORT ON (B)(6) 2015 THE SITE HAS HEALED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512414 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention