BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES¿ ULTRA 3D IMPLANT

    MDR report key: 16920936 · Received May 12, 2023

    Report

    Report Number
    3006556115-2023-00898
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    May 3, 2023
    Report Date
    May 4, 2023
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016870255
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE EXPLANTED DEVICE WAS RECEIVED BY ADVANCED BIONICS MAY 17, 2023. 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

    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'S DEVICE WAS EXPLANTED. DEVICE TESTING REVEALED RESULTS WITHIN NORMAL LIMITS. ADVANCED BIONICS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308865 HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-04 NA 07630016870255

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention