BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION¿ IMPLANT

    MDR report key: 19934197 · Received August 7, 2024

    Report

    Report Number
    3006556115-2024-01248
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    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

    DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION: H.10/H.11. ADDITIONAL INFORMATION SECTION: H.6. 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. THE COMPANY WAS INFORMED THAT THE EXPLANTED DEVICE WILL NOT BE RETURNED TO THE COMPANY FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD NOTED NO ANOMALIES. 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. 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

    ADDITIONAL INFORMATION SECTION: H.6. 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.

    Description of Event or Problem · 0

    ADVANCED BIONICS WAS NOTIFIED THE RECIPIENT REPORTEDLY PURSUED REVISION SURGERY FOR TECHNOLOGY UPGRADE. 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
    608916 CLARION¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female