BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 283401 · Received June 23, 2000

    Report

    Report Number
    2029203-2000-00016
    Event Type
    Other
    Date Received
    June 23, 2000
    Date of Event
    December 1, 1999
    Report Date
    June 23, 2000
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT CENTER HAS BEEN MONITORING THE PT'S PERFORMANCE FOR SEVERAL MONTHS. WHEN THE PT WAS SEEN AT THE IMPLANT CENTER FOR DEVICE EVAL IN 2000, TESTING CONFIRMED THAT PT'S DEVICE WAS NO LONGER FUNCTIONING. REVISION SURGERY TOOK PLACE IN 2000 AND THE PT WAS REIMPLANTED WITH ANOTHER CLARION DEVICE.

    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 8 YR