BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 374759 · Received January 31, 2002

    Report

    Report Number
    2029203-2002-00014
    Event Type
    Injury
    Date Received
    January 31, 2002
    Date of Event
    November 14, 2001
    Report Date
    January 30, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SEEN AT THE IMPLANT CENTER IN NOVEMBER 2001 FOR COMPLAINT OF DISCOMFORT AT THE IMPLANT. IT WAS REPORTED BY THE SURGEON THAT THE IMPLANT HAD SHIFTED SEVERAL YEARS AGO. IT WAS NOT A PROBLEM UNTIL THE PATIENT STARTED WEARING THE COMBINATION OF THE GLASSES AND BEHIND-THE-EAR UNIT. REVISION SURGERY HAS BEEN SCHEDULED.

    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 44 YR Required Intervention