BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION¿ IMPLANT

    MDR report key: 13736730 · Received March 11, 2022

    Report

    Report Number
    3006556115-2022-00407
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 8, 2022
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    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

    ADDITIONAL INFORMATION: SECTION E.1, E.2, E.3, & G.3. DISCLAIMER: ADVANCED BIONICS DOES NOT INTEND THAT THIS REPORT BE ANY ADMISSION OF LIABILITY, FAULT OR PRODUCT DEFECT.

    Additional Manufacturer Narrative · 0

    THE RECIPIENT REPORTEDLY ELECTED REVISION FOR A TECHNOLOGY UPGRADE. 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 COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913019 CLARION¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male