BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA 3D IMPLANT

    MDR report key: 20322579 · Received September 27, 2024

    Report

    Report Number
    3006556115-2024-01528
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    00840094455771
    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

    CORRECTION: SECTION: A1, A.2, A.3, E.1, E.2, E.3, G.2, B.3, B.5, D.1, D.4, H.10, H.4, D.6A, D.6B, D.5, H.6. ADVANCED BIONICS CONSIDERS THIS EVENT AS NON-REPORTABLE. THIS EVENT WAS REPORTED IN ERROR, THERE IS NO COMPLAINT AGAINST THIS DEVICE. 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 EXPLANTED DEVICE WAS RECEIVED BY ADVANCED BIONICS SEPTEMBER 25, 2024. 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.

    Description of Event or Problem · 0

    THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED. 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
    1491331 HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-05 NA 00840094455771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male