BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA 3D IMPLANT

    MDR report key: 22005890 · Received May 12, 2025

    Report

    Report Number
    3006556115-2025-00668
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    November 14, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016861789
    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

    ADDITIONAL INFORMATION: SECTION H.6. THE RECIPIENT PRESENTED WITH RECURRING HEADACHES AND EAR PAIN. 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

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT HAS NOT PROVIDED CONSENT DESPITE SEVERAL REQUESTS TO THE RECIPIENT¿S MEDICAL INSTITUTION TO OBTAIN AND PROVIDE THE CONSENT. AS A RESULT, NO CONCLUSION CAN BE DRAWN AT THIS TIME. IF THE CONSENT IS RECEIVED AT A LATER DATE, THE ISSUE WILL BE RE-OPENED, AND THE RESULTS OF THE ANALYSIS WILL BE REPORTED. THE DEVICE REMAINS INTACT IN A LOCKED VAULT AT AB, LLC UNTIL CONSENT IS OBTAINED. 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: 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B.3, D.6B, H.6. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WILL NOT BE RE-IMPLANTED. THE RECIPIENT IS DOING WELL. THE EXPLANTED DEVICE IS REQUESTED TO RETURN TO ADVANCED BIONICS FOR ANALYSIS. ADVANCED BIONICS IS CURRENTLY ATTEMPTING TO OBTAIN CONSENT FROM THE RECIPIENT. 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 PAIN. THE RECIPIENT IS A NON-USER OF THE DEVICE. A REVIEW OF THE TEST DATA INDICATES IMPEDANCE ISSUES, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465844 HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-05 NA 07630016861789

    Patients

    Seq Age Sex Outcome Treatment
    1