BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES¿ ULTRA IMPLANT

    MDR report key: 16482645 · Received March 3, 2023

    Report

    Report Number
    3006556115-2023-00424
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 28, 2023
    Report Date
    February 27, 2023
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    07630016844584
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT HAS NOT PROVIDED CONSENT DESPITE SEVERAL REQUESTS TO THE RECIPIENT¿S MEDICAL INSTITUTION TO OBTAIN AND PROVIDE THE CONSENT. AS A RESULT, NO CONCLUSION CAN BE DRAWN AT THIS TIME. IF THE CONSENT IS RECEIVED AT A LATER DATE, THE ISSUE WILL BE RE-OPENED AND THE RESULTS OF THE ANALYSIS WILL BE REPORTED. THE DEVICE REMAINS INTACT IN A LOCKED VAULT AT AB, LLC UNTIL CONSENT IS OBTAINED. 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 CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. ADVANCED BIONICS RECEIVED PERMISSION ON BEHALF OF THE RECIPIENT TO PROCEED WITH FAILURE ANALYSIS ON 04/18/2024. THE EXTERNAL VISUAL INSPECTION REVEALED SILICONE DAMAGE ON THE TOP AND BOTTOM COVER OF THE DEVICE, AS WELL AS A SEVERED ELECTRODE. 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 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 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

    THE RECIPIENT WAS REPORTEDLY EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE. 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

    A REVIEW OF THE TEST DATA INDICATES IMPEDANCE ISSUES. REVISION SURGERY IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914012 HIRES¿ ULTRA IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1600-05 NA 07630016844584

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female