BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR BAHA ATTACT SYSTEM

    MDR report key: 5884906 · Received August 17, 2016

    Report

    Report Number
    6000034-2016-01675
    Event Type
    Injury
    Date Received
    August 17, 2016
    Date of Event
    May 9, 2016
    Report Date
    August 6, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS FILED ON AUGUST 18, 2016 BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE MAGNET AND NECROSIS OF THE SKIN FLAP. SUBSEQUENTLY THE MAGNET WAS EXPLANTED ON (B)(6) 2016 AND THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS COCHLEAR BAHA ATTACT SYSTEM AND PMA IS K131240 NOT FLANGE FIXTURE AND ABUTMENT AND PMA K100360 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED ON OCTOBER 10, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535176 COCHLEAR BAHA ATTACT SYSTEM LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention