BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA IMPLANT

    MDR report key: 20327427 · Received September 27, 2024

    Report

    Report Number
    3006556115-2024-01489
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    March 4, 2025
    Report Date
    September 18, 2024
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016861727
    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 D.6B. ADDITIONAL INFORMATION: SECTION B.3. 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

    ADDITIONAL INFORMATION SECTION D.9. THE EXPLANTED DEVICE WAS RECEIVED BY ADVANCED BIONICS (B)(6) 2025. 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.

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT WILL REPORTEDLY NOT PURSUE REVISION SURGERY AT THIS TIME. THE RECIPIENT IS WEARING THE DEVICE. 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

    ADVANCED BIONICS RECEIVED PERMISSION ON BEHALF OF THE RECIPIENT TO PROCEED WITH FAILURE ANALYSIS ON 06/04/2025. THE EXPLANTED DEVICE WAS RECEIVED AT THE COMPANY ON APRIL 24, 2025 AND IS CURRENTLY UNDERGOING ANALYSIS. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SEVERED AND SILICONE DAMAGE WAS OBSERVED ON THE TOP AND BOTTOM COVER OF THE DEVICE. THESE ARE BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE PHOTOGRAPHIC IMAGING INSPECTION REVEALED A BROKEN ELECTRODE WITHIN THE ELECTRODE POCKET. SYSTEM LOCK WAS VERIFIED. THE CONDITION OF THE ELECTRODE PREVENTED AN ELECTRICAL TEST FROM BEING PERFORMED. THE DEVICE PASSED SOME OF THE ELECTRICAL TESTS PERFORMED. THE FAILURE OF THIS DEVICE IS ATTRIBUTED TO AN ELECTRODE SHORT IN THE ELECTRODE POCKET. A CORRECTIVE ACTION WAS IMPLEMENTED. THIS VERSION OF THE HIRES ULTRA DEVICE IS NO LONGER DISTRIBUTED. 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

    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 RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. 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
    1663038 HIRES¿ ULTRA IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1600-04 NA 07630016861727

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male