BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 218778 · Received April 10, 1999

    Report

    Report Number
    2029203-1999-00012
    Event Type
    Other
    Date Received
    April 10, 1999
    Date of Event
    September 1, 1998
    Report Date
    March 16, 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 5 1/2 YR OLD BOY, WAS ORIGINALLY IMPLANTED ON MARCH 20, 1997. HIS IMPLANT SYSTEM FUNCTIONED NORMALLY FROM THE TIME OF IMPLANT UNTIL SEPTEMBER, 1998. ACCORDING TO INFO REC'D FROM THE IMPLANT CENTER, THE CHILD REC'D A BLOW TO THE HEAD SOMETIME DURING THE WEEK OF SEPTEMBER 12, 1998. PT'S DEVICE IMMEDIATELY CEASED FUNCTIONING. NEITHER THE EXACT DATE NOR THE CIRCUMSTANCES SURROUNDING THE INCIDENT ARE UNKNOWN AT THIS TIME. REVISION SURGERY TOOK PLACE ON SEPTEMBER 23, 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-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR