BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K¿ IMPLANT

    MDR report key: 22579788 · Received July 23, 2025

    Report

    Report Number
    3006556115-2025-00984
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    January 18, 2023
    Report Date
    July 2, 2025
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECIPIENT WAS REPORTEDLY EXPLANTED DUE TO EXPERIENCING A FAILURE IN-SITU DUE TO LOSS OF LOCK. FAILURE IN-SITU DOCUMENTED IN MDR # 3006556115-2019-00838. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H.10/H.11, H.6. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE DEVICE PASSED SOME OF THE ELECTRICAL TESTS PERFORMED. THE DEVICE PASSED THE MECHANICAL TESTS PERFORMED. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTIONS E.1, E..2 & E.3, G.2 & H.10 & H.11. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE. THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SEVERED. THIS IS BELIEVED TO HAVE OCCURRED DURING EXPLANT SURGERY. THE PHOTOGRAPHIC IMAGING INSPECTION REVEALED BROKEN ANTENNA COIL WIRES. SYSTEM LOCK COULD NOT BE OBTAINED AT ANY SPACING. THE CONDITION OF THE ELECTRODE PREVENTED AN ELECTRICAL TEST FROM BEING PERFORMED. THE DEVICE PASSED SOME OF THE TESTS PERFORMED. THIS DEVICE HAD BROKEN ANTENNA COIL WIRES. A CORRECTIVE ACTION WAS IMPLEMENTED. THIS OLDER DEVICE CONFIGURATION IS NO LONGER MANUFACTURED. THIS IS THE FINAL REPORT. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Description of Event or Problem · 0

    THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. ONCE ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915344 HIRES 90K¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Required Intervention