BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 375028 · Received February 1, 2002

    Report

    Report Number
    2029203-2002-00017
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    March 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED FROM THE IMPLANT CENTER, THE PATIENT WAS SEEN AT THE CENTER IN 2001. AT THAT TIME, IT WAS THOUGHT THAT THE PATIENT WAS EXPERIENCING SUPERFICIAL WOUND INFECTION. FOUR MONTHS LATER, THE CLARION DEVICE WAS REMOVED DUE TO MASTOIDITIS AND MASTOID ABCESS. THE AREA WAS DRAINED AND ANTIBIOTICS WERE PRESCRIBED. 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 49 YR Required Intervention