BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA 3D IMPLANT

    MDR report key: 21874272 · Received April 21, 2025

    Report

    Report Number
    3006556115-2025-00594
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    October 30, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016870262
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION: H.6. THE RECIPIENT WAS NOT RE-IMPLANTED. THE RECIPIENT WILL REPORTEDLY NOT BE REIMPLANTED AT THIS TIME DUE TO A CHOLESTEATOMA. 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 B.3, D.6B, H.6. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION SECTION B.7. 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

    ADDITIONAL INFORMATION SECTION: D.9. ADVANCED BIONICS IS CURRENTLY ATTEMPTING TO OBTAIN CONSENT FROM THE RECIPIENT. THE DEVICE REMAINS INTACT IN A LOCKED VAULT AT AB, LLC UNTIL CONSENT IS OBTAINED. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Description of Event or Problem · 0

    A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911017 HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-05 NA 07630016870262

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown