BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA 3D IMPLANT

    MDR report key: 19595146 · Received June 24, 2024

    Report

    Report Number
    3006556115-2024-01002
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    March 4, 2025
    Report Date
    June 19, 2024
    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

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT WILL NOT PURSUE REVISION SURGERY AT THIS TIME. THE RECIPIENT CONTINUES TO USE THE DEVICE AND WILL BE MONITORED BY THE FACILITY. NO FURTHER DETAILS WILL BE PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTIONS B.3 & D.6B. 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. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT HAS REFUSED TO CONSENT. AS A RESULT, NO CONCLUSION CAN BE DRAWN AT THIS TIME. IF 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

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT REPORTEDLY DID NOT EXPERIENCE DECREASED PERFORMANCE. THE RECIPIENT HAS REFUSED TO CONSENT. AS A RESULT, NO CONCLUSION CAN BE DRAWN AT THIS TIME. IF 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.

    Description of Event or Problem · 0

    THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177988 HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-05 NA 07630016870262

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Unknown