BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIM400 IMPLANT MAGNET

    MDR report key: 23242055 · Received October 8, 2025

    Report

    Report Number
    6000034-2025-03600
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 17, 2025
    Report Date
    January 7, 2026
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT IS ASSOCIATED WITH A RETURNED DEVICE; HOWEVER, THE PROVIDED CLINICAL INFORMATION WAS REVIEWED BY THE MANUFACTURER AND NO SPECIFIC DEVICE ANALYSIS IS DEEMED NECESSARY AT THIS TIME. PREVIOUS PRODUCT EXAMINATIONS HAVE NOT SHOWED ANY RELATIONSHIP BETWEEN A PRODUCT GEOMETRICAL DEVIATION AND THE REPORTED CLINICAL COMPLICATION. ADDITIONALLY, THERE ARE NO INDICATIONS THAT A PRODUCT FAILURE HAS CONTRIBUTED TO THE REPORTED ISSUE. ELECTIVE REMOVAL OF AN IMPLANT IS A PROCEDURE WHICH REQUIRES MEDICAL/SURGICAL INTERVENTION. THE REPORT FREQUENCY FOR THESE COMPLICATIONS IS BEING MONITORED UNDER CBAS COMPLAINT AND MEDICAL DEVICE REPORTING DATA MONITORING PLAN AND THE STATUS IS UPDATED ON A MONTHLY BASIS. THIS EVENT IS ADDED TO THIS MONITORING.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CORRECT BRAND NAME (D1); COMMON DEVICE NAME (D2A); MODEL NUMBER AND CATALOG NUMBER (D4) AND PMA/510(K) (G4) ARE BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM, 93550 AND K131240 RESPECTIVELY; NOT BI300 IMPLANT 4MM; COCHLEAR BAHA CONNECT SYSTEM, 92129 AND K100360 AS PREVIOUSLY REPORTED IN INITIAL MDR SUBMITTED ON OCTOBER 08, 2025. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED NO BENEFIT WITH THE DEVICE DUE TO PROGRESSIVE HEARING LOSS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 DUE TO BONE CONDUCTION THRESHOLDS DROPPED OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508292 BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 93550 LOT# 99224

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention