BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 375018 · Received February 1, 2002

    Report

    Report Number
    2029203-2002-00038
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    February 1, 2001
    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
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED IN 2001. THE PATIENT'S COMPLETE EXPERIENCE PRIOR TO DEVICE EXPLANTATION IS UNKNOWN. HOWEVER, IT IS KNOWN THAT PT SUFFERED FROM INFECTION. THERE WERE NO REPORTS OF ICS PERFORMANCE PROBLEMS PRIOR TO DEVICE EXPLANTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention