BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K¿ IMPLANT

    MDR report key: 22955340 · Received September 3, 2025

    Report

    Report Number
    3006556115-2025-01248
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    March 10, 2014
    Report Date
    August 27, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION H.6. THE RECIPIENT REPORTEDLY ELECTED REVISION SURGERY DUE TO SWELLING AND EXTRUSION. 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.

    Additional Manufacturer Narrative · 0

    THE RECIPIENT WAS REPORTEDLY RE-IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE ON (B)(6) 2025. 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 & H.6. INFORMATION WAS RECEIVED THAT THE IMPLANT WAS DISLOCATED, AS WELL AS NOTING A SKIN DEFECT AND INFECTION. 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.

    Description of Event or Problem · 0

    THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. ONCE ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450750 HIRES 90K¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1500-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male