BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 371974 · Received January 15, 2002

    Report

    Report Number
    2029203-2001-00131
    Event Type
    Malfunction
    Date Received
    January 15, 2002
    Date of Event
    December 1, 2001
    Report Date
    January 15, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED NO SOUND AND WAS SEEN AT THE IMPLANT CENTER FOR DEVICE EVALUATION. DEVICE WAS ABLE TO LINK HOWEVER ALL ELECTRODE IMPEDANCES WERE OUT OF RANGE. REVISION SURGERY WAS SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR