BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K¿ IMPLANT

    MDR report key: 22628950 · Received July 28, 2025

    Report

    Report Number
    3006556115-2025-01078
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    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 D.9. THE RECIPIENT WAS NOT RE-IMPLANTED. 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. 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 HEALED. 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

    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 REPORTEDLY ELECTED TO EXPLANT THE DEVICE. THE RECIPIENT WAS REPORTEDLY A NON-USER OF THE DEVICE. THE RECIPIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS CURRENTLY ATTEMPTING TO OBTAIN CONSENT FROM THE RECIPIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685921 HIRES 90K¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male