BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA 3D IMPLANT

    MDR report key: 19656670 · Received July 2, 2024

    Report

    Report Number
    3006556115-2024-01040
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 26, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SEVERED. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION PREVENTED AN ELECTRICAL TEST FROM BEING PERFORMED. THE DEVICE PASSED THE ELECTRICAL TESTS PERFORMED. THE DEVICE PASSED THE MECHANICAL TEST PERFORMED. THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. THE DEVICE PASSED THE TESTS PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS RECEIVED PERMISSION ON BEHALF OF THE RECIPIENT TO PROCEED WITH FAILURE ANALYSIS ON JULY 23, 2024. THE EXPLANTED DEVICE WAS RECEIVED AT THE COMPANY ON JULY 19, 2024 AND IS CURRENTLY UNDERGOING ANALYSIS. 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 EXPERIENCED POOR PERFORMANCE. THE RECIPIENT PRESENTED WITH SOUND QUALITY ISSUES DESPITE THE DEVICE TESTING RESULTS WERE WITHIN NORMAL LIMITS. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601888 HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-05 NA 00840094455771

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown