BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 374995 · Received February 1, 2002

    Report

    Report Number
    2029203-2002-00031
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    March 1, 1999
    Report Date
    January 31, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1997, THE CENTER REPORTED THAT THIS PATIENT WAS EXPERIENCING BALANCE PROBLEMS WITH THE USAGE OF THE DEVICE. THE PATIENT REPORTEDLY STOPPED USING THE DEVICE SOMETIME LATER. THE DEVICE WAS EXPLANTED IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention