BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8/23/2023

    MDR report key: 17870465 · Received October 4, 2023

    Report

    Report Number
    3006556115-2023-01660
    Event Type
    Injury
    Date Received
    October 4, 2023
    Report Date
    September 13, 2023
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    UDI-DI
    00840094456020
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 REPORTEDLY HEALED. THE RECIPIENT'S DEVICE WAS SUCCESSFULLY ACTIVATED. NO FURTHER TREATMENT DETAILS WILL BE PROVIDED. 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 DISCOMFORT AND NON-AUDITORY SENSATION FOLLOWING INITIAL IMPLANT SURGERY. THE RECIPIENT WAS PRESCRIBED AN ANTIVIRAL MEDICATION (TYPE UNKNOWN). ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87383 8/23/2023 COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1601-05 NA 00840094456020

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention