BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 120105 · Received September 10, 1997

    Report

    Report Number
    2029203-1997-00016
    Event Type
    Other
    Date Received
    September 10, 1997
    Date of Event
    August 8, 1997
    Report Date
    August 11, 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

    DEVICE EVALUATION CONSISTED OF FOLLOWING: A REVIEW OF DEVICE HISTORY RECORD (DHR), VISUAL EXAMINATION, ELECTRICAL TESTING, AND X-RAY EXAMINATION. CASE WAS FOUND TO BE CRACKED. CRACKED CASE ALLOWED INTRUSION OF FLUIDS INTO ICS CAVITY RESULTING IN ELECTRICAL FAILURE. REFER TO ATTACHED DEVICE FAILURE ANALYSIS REPORT. THIS DEVICE EXPERIENCED NO FAILURES DURING MFG CYCLE. INITIAL VISUAL EXAMINATION REVEALED THAT CASE HAD SUSTAINED MANY CRACKS. ELECTRODE WAS INTACT AND APPEARED NORMAL. FAILURE OF THIS ICS IS ATTRIBUTED TO CRACKED CASE AND LOSS OF HERMETIC SEAL. CRACKED CASE ALLOWED INSTRUSION OF FLUIDS INTO ICS CAVITY RESULTING IN ELECTRICAL FAILURE. CERAMIC CASE USED IN THIS DEVICE WAS MFG USING ISOPRESS MFG PROCESS. ADVANCED BIONICS HAS DETERMINED THAT CASES MFG USING ISOPRESS PROCESS ARE LESS RESISTANT TO IMPACT DAMAGE THAN CASES MFG USING INJECTION MOLDING PROCESS. BECAUSE OF PREVIOUS INSTANCES OF CASE DAMAGE IN PEDIATRIC POPULATION, ADVANCED BIONICS HAS TERMINATED USAGE OF CASES MFG USING ISOPRESS PROCESS IN FAVOR OF CASES MFG USING INJECTION MOLDING PROCESS. ADVANCED BIONCIS HAS ALOS DEVELOPED AND IMPLEMENTED SCREEING PROCEDURE TO ASSURE THAT CASE LOTS ACCEPTED POSSES UNIFORM MINIMUM CASE STRENGTH TO INCREASE THEIR ABILITY TO WITHSTAND GREATER IMPACT LEVLES EXPERIENCED BY PEDIATRIC POPULATION.

    Description of Event or Problem · 1

    A 3 YEAR OLD BOY, FELL AND HIT HIS HEAD ON THE FLOOR. ACCORDING TO THE IMPLANT CENTER, ALTHOUGH HE HIT HIS HEAD AT THE IMPLANT SITE, THE IMPACT WAS NOT VERY HARD AS THE CHILD DID NOT CRY. THE DEVICE CONTINUED TO FUNCTION PROPERLY FOR THE NEXT TWO DAYS. HE WAS TAKEN TO THE IMPLANT CENTER ON AUGUST 8, 1997 BECAUSE THE "LINK" LIGHT ON HIS SPEECH PROCESSOR BEGAN TO FLASH INDICATING THAT THE SPEECH PROCESSOR WAS UNABLE TO COMMUNICATE WITH THE IMPLANTED DEVICE. IN AN ATTEMPT TO ACHIEVE LINK BETWEEN THE EXTERNAL AND INTERNAL COMPONENTS OF THE SYSTEM, VARIOUS HEADPIECES AND CABLES WERE USED.IN EACH INSTANCE, HOWEVER TESTING WITH THE PORTABLE COCHLEAR IMPLANT TESTER (PCIT) INDICATED A "NO LINK" STATUS. REVISION SURGERY TOOK PLACE ON AUGUST 18, 1997.

    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 3 YR