BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 103842 · Received July 3, 1997

    Report

    Report Number
    2029203-1997-00011
    Event Type
    Other
    Date Received
    July 3, 1997
    Date of Event
    May 1, 1997
    Report Date
    June 4, 1997
    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

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILURE ANALYSIS REPORT PROVIDED IN FOLLOW-UP #1, INCORRECTLY IDENTIFIED THE EXPLANTED DEVICE AS BEING MANUFACTURED USING THE ISOPRESS METHOD. THE ACTUAL METHOD WAS INJECTION-MOLDED.

    Description of Event or Problem · 1

    AN 8 YR OLD BOY SLIPPED WHILE IN A SWIMMING POOL. ALTHOUGH THE EXACT DATE OF THE INCIDENT IS UNKNOWN, THE CHILD WAS SEEN AT THE IMPLANT CENTER ON 5/21/97 FOR A DEVICE EVAL. AT THAT TIME, LINK BETWEEN THE IMPLANTED DEVICE AND THE EXTERNAL EQUIPMENT WAS NOT ACHIEVABLE. THE LACK OF LINK WAS BELIEVED TO BE THE RESULT OF THE SWELLING AROUND THE IMPLANT SITE. CHILD RETURNED TO THE CENTER ON MAY 27, 1997. THE SWELLING HAD SUBSIDED, BUT COMMUNICATION BETWEEN THE INTERNAL AND EXTERNAL COMPONENTS OF THE SYSTEM WAS STILL UNACHIEVABLE. REVISION SURGERY TOOK PLACE ON 6/16/97.

    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 YR Other
    2