BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 197259 · Received November 10, 1998

    Report

    Report Number
    2029203-1998-00029
    Event Type
    Other
    Date Received
    November 10, 1998
    Date of Event
    October 1, 1998
    Report Date
    October 5, 1998
    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

    THE PT WAS ORIGINALLY IMPLANTED ON MAY 12, 1997. THERE WERE NO REPORTS OF ANY PROBLEMS WITH HIS SYSTEM THROUGHOUT THE NEXT YEAR. ON OCTOBER 1, 1998 WHILE PLAYING ON A PLAYGROUND, THE PT BUMPED HEADS WITH ANOTHER CHILD. THERE WAS NO VISIBLE EVIDENCE OF TRAUMA AT THE IMPLANT SITE AND HIS SYSTEM CONTINUED TO FUNCTION FOR THE NEXT TWO DAYS. ON OCTOBER 3, 1998 HIS DEVICE STOPPED WORKING. THE PT WAS SEEN AT THE IMPLANT CTR ON OCTOBER 5, 1998. ALTHOUGH THE AUDIOLOGIST CHANGED OUT ALL EXTERNAL EQUIPMENT, THE INTERNAL AND EXTERNAL COMPONENTS OF THE SYSTEM WERE UNABLE TO ACHIEVE LINK. EXPLANTATION TOOK PLACE ON OCTOBER 8, 1998. THE PT WAS REIMPLANTED WITH ANOTHER CLARION DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR