BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA IMPLANT

    MDR report key: 19710466 · Received July 10, 2024

    Report

    Report Number
    3006556115-2024-01081
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    August 15, 2024
    Report Date
    July 4, 2024
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016841002
    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

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE EXTERNAL VISUAL INSPECTION REVEALED TOOL DAMAGE IN THE SILICONE OVERMOLD ON THE TOP AND BOTTOM COVERS. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. 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.

    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: SECTIONS B.3, D.6B & H.6. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. ADVANCED BIONICS RECEIVED PERMISSION ON BEHALF OF THE RECIPIENT TO PROCEED WITH FAILURE ANALYSIS ON (B)(6), 2024. THE EXPLANTED DEVICE WAS RECEIVED AT THE COMPANY ON (B)(6), 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 IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930266 HIRES¿ ULTRA IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1600-04 NA 07630016841002

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female