BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA IMPLANT

    MDR report key: 20136895 · Received September 4, 2024

    Report

    Report Number
    3006556115-2024-01288
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016855696
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    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

    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

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SEVERED 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 PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. THE CONDITION OF THE ELECTRODE PREVENTED AN ELECTRICAL TEST FROM BEING PERFORMED. THE DEVICE PASSED SOME OF 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 HIRES ULTRA DEVICE 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.

    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
    1105331 HIRES¿ ULTRA IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1600-05 NA 07630016855696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose