BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CI-1600-04

    MDR report key: 23041957 · Received September 12, 2025

    Report

    Report Number
    3006556115-2025-01212
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    September 9, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016861697
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D.9. 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 H.6. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS KINKED AND SILICONE DAMAGE WAS OBSERVED ON THE TOP AND BOTTOM COVER OF THE DEVICE. THESE ARE BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. THE DEVICE PASSED THE ELECTRICAL TESTS PERFORMED. THE FAILURE OF THIS DEVICE IS ATTRIBUTED TO AN ELECTRODE SHORT IN THE ELECTRODE POCKET. A CORRECTIVE ACTION WAS IMPLEMENTED. THIS VERSION OF THE ULTRA IS NO LONGER DISTRIBUTED. 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.

    Description of Event or Problem · 0

    THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170821 CI-1600-04 COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC HIRES¿ ULTRA IMPLANT NA 07630016861697

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female