BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 369999 · Received January 2, 2002

    Report

    Report Number
    2029203-2001-00120
    Event Type
    Malfunction
    Date Received
    January 2, 2002
    Date of Event
    May 1, 2001
    Report Date
    December 20, 2001
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS BEEN MONITORED SINCE MARCH 2001 FOR REPORTED PERCEPT PROBLEMS AND FACIAL TWITCHING. IN MAY 2001, ALTHOUGH NO ANOMALY WITH THE DEVICE WAS DETECTED, THE DECISION FOR REVISION SURGERY WAS MADE.

    Description of Event or Problem · 1

    PT HAS BEEN MONITORED SINCE 3/2001 FOR REPORTED PERCEPT PROBLEMS AND FACIAL TWITCHING. IN 5/2001, ALTHOUGH NO ANOMALY WITH THE DEVICE WAS DETECTED, THE DECISION FOR REVISION SURGERY WAS MADE.

    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 43 YR