BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA IMPLANT

    MDR report key: 14308407 · Received May 6, 2022

    Report

    Report Number
    3006556115-2022-00722
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    June 28, 2022
    Report Date
    May 2, 2022
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016861727
    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

    DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    THE RECIPIENT'S DEVICE WAS REPORTEDLY EXPLANTED. THE RECIPIENT WAS REIMPLANTED 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

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT HAS REFUSED TO CONSENT TO DEVICE ANALYSIS AND THE EXPLANTED DEVICE WILL NOT RETURN TO ADVANCED BIONICS. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO ANOMALIES WERE NOTED. 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.

    Description of Event or Problem · 0

    THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249875 HIRES¿ ULTRA IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1600-04 NA 07630016861727

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female