BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 288887 · Received August 4, 2000

    Report

    Report Number
    2029203-2000-00022
    Event Type
    Other
    Date Received
    August 4, 2000
    Date of Event
    July 7, 2000
    Report Date
    August 1, 2000
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SEEN AT THE IMPLANT CENTER FOR DEVICE EVAL IN JULY 2000. TESTING CONDUCTED AT THE CENTER CONFIRMED THAT THE 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 7 YR