BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 209896 · Received February 12, 1999

    Report

    Report Number
    2029203-1999-00001
    Event Type
    Other
    Date Received
    February 12, 1999
    Date of Event
    January 11, 1999
    Report Date
    January 11, 1999
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 17 YEAR-OLD FEMALE, WAS ORIGINALLY IMPLANTED ON APRIL 15, 1996. HER SYSTEM FUNCTIONED NORMALLY OVER THE NEXT TWO YEARS. ON JANUARY 1, 1999, WHILE PLAYING WITH HER SISTER, PT HIT HER HEAD ON THE CORNER OF A WALL DIRECTLY AT THE IMPLANT SITE. IT IS UNKNOWN WHETHER OR NOT DEVICE FUNCTIONALITY CEASED AT THE TIME OF IMPACT OR LATER. PT WAS SEEN AT THE IMPLANT CTR ON JANUARY 8, 1999 FOR COMPLETE DEVICE EVALUATION. TESTING CONDUCTED AT THE CENTER CONFIRMED HER SYSTEM WAS NO LONGER FUNCTIONING. REVISION SURGERY TOOK PLACE ON JANUARY 15, 1999. PT WAS REIMPLANTED WITH ANOTHER CLARION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR