BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 176811 · Received July 10, 1998

    Report

    Report Number
    2029203-1998-00016
    Event Type
    Other
    Date Received
    July 10, 1998
    Date of Event
    May 1, 1998
    Report Date
    June 1, 1998
    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

    AN 8 1/2 YEAR-OLD BOY, WAS ORIGINALLY IMPLANTED ON NOVEMBER 22, 1995. ACCORDING TO THE INFO REC'D FROM THE IMPLANT CENTER, HE FELL AND HIT HIS HEAD SOMETIME DURING THE WEEK OF MAY 30, 1998. THE EVENING OF THE FALL, THE CHILD TOLD HIS PARENTS THAT HE COULD NO LONGER HEAR WITH HIS CLARION SYSTEM. PG039 WAS SEEN AT THE IMPLANT CENTER ON OR ABOUT MAY 2, 1998 FOR DEVICE EVALUATION. NEITHER THE EXACT DATE OF IMPACT NOR THE CIRCUMSTANCES SURROUNDING THE EVENT WERE DISCUSSED WITH THE COCHLEAR IMPLANT TEAM DURING THE EVALUATION SESSION. TESTING CONDUCTED AT THE CENTER CONFIRMED THE CLARION WAS NO LONGER FUNCTIONING. EXPLANATION/REIMPLANTATION TOOK PLACE ON JUNE 15, 1998. 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-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8.5 YR