BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 107631 · Received July 17, 1997

    Report

    Report Number
    2029203-1997-00014
    Event Type
    Other
    Date Received
    July 17, 1997
    Date of Event
    July 3, 1997
    Report Date
    July 3, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H.6 - DEVICE EVALUATION CONSISTED OF THE FOLLOWING: A REVIEW OF THE DEVICE HISTORY RECORD (DHR); VISUAL EXAMINATION AND X-RAY EXAMINATION. SECTION H.6 - THE CASE WAS FOUND TO BE FRACTURED. THE CRACKED CASE ALLOWED THE INTRUSION OF FLUIDS INTO THE ICS CAVITY RESULTING IN ELECTRICAL FAILURE. REFER TO ATTACHED DEVICE FAILURE ANALYSIS REPORT. PT EXPERIENCE PRIOR TO FAILURE: ON 7/3/97, ADVANCED BIONICS WAS CONTACTED AND INFORMED THT THE PT'S SPEECH PROCESSOR WAS NOT ABLE TO ACHIEVE LINK WITH THE IMPLANTED DEVICE. PCIT TESTING COULD NOT ESTABLISH LINK WITH THE DEVICE. THERE WAS NO REPORT OF HEAD IMPACTS. REVISION SURGERY WAS SCHEDULED. VISUAL EXAMINATION: INITIAL VISUAL EXAMINATION REVEALED THAT THE CASE HAD SUSTAINED MANY CRACKS. THE ELECTRODE WAS INTACT AND APPEARED NORMAL. BRIGHT LIGHT EXAMINATION: WAS NOT PERFORMED SINCE X-RAY EXAMINATION WAS PERFORMED. X-RAY EXAMINATION: X-RAY EXAMINATION DID NOT REVEAL THE PRESENCE OF ANY INTERNAL DAMAGE TO THE HYBRID DEVICE. ELECTICAL TESTING: ELECTRICAL TESTING WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. CASE HERMETICITY TESTING (LEAD TESTING): LEAK TESTING WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. CASE REMOVAL: CASE REMOVAL WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. INTERNAL VISUAL EXAMINATION: INTERNAL VISUAL EXAMINATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. INTERNAL ELECTRICAL TESTING: INTERNAL ELECTRICAL TESTING WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. CONCLUSION: THE FAILURE OF THIS ICS IS ATTRIBUTED TO THE CRACKED CASE AND LOSS OF HERMETIC SEAL. THE CRACKED CASE ALLOWED THE INTRUSION OF FLUIDS INTO THE ICS CAVITY RESULTING IN ELECTICAL FAILURE. CORRECTIVE ACTION: THE CERAMIC CASE USED IN THIS DEVICE WAS MANUFACTURED USING THE ISOPRESS MFG PROCESS. ADVANCED BIONICS HAD DETERMINED THAT CASES MANUFACTURED USING THE ISOPRESS PROCESS ARE LESS RESISTANT TO IMPACT DAMAGE THAN CASES MANUFACTURED USING THE INJECTION MOLDING PROCESS. BECAUSE OF PREVIOUS INSTANCES OF CASE DAMAGE IN THE PEDIATRIC POPULATION, ADVANCED BIONICS HAS TERMINATED THE USAGE OF CASES MANUFACTURED USING THE ISOPRESS IN FAVOR OF CASES MANUFACTURED USING THE INJECTION MOLDING PROCESS. ADVANCED BIONICS HAS ALSO DEVELOPED AND IMPLEMENTED A SCREENING PROCEDURE TO ASSURE THAT CASE LOTS ACCEPTED POSSES UNIFORM MIMIMUM CASE STRENGTH TO INCREASE THEIR ABILITY TO WITHSTAND THE GREATER IMPACT LEVELS EXPERIENCED BY THE PEDIATRIC POPULATION.

    Description of Event or Problem · 1

    ON 7/3/97 THE IMPLANT CENTER CONTACTED ADVANCED BIONICS TO REPORT THAT P234 WAS UNABLE TO OBTAIN "LINK" (I.E., ABILITY TO COMMUNICATE BETWEEN THE IMPLANTED DEVICE AND THE EXTERNAL EQUIPMENT) WITH HIS CLARION SYSTEM. IN AN ATTEMPT TO ESTABLISH LINK, A COMPLETE EXCHANGE OF THE HEADPIECE, CABLE AND SPEECH PROCESSOR WAS MADE. NO LINK WAS ACHIEVED. TESTING CONDUCTED WITH THE PORTABLE COCHLEAR IMPLANT TESTER (PCIT) CONFIRMED THAT P234'S DEVICE WAS NOT FUNCTIONING PROPERLY. P234'S FAMILY REPORTED THAT THERE HAD BEEN NO DIRECT IMPACTS OR TRAUMA TO THE IMPLANT SITE IN THE MONTHS PRECEDING THE DEVICE MALFUNCTION. REVISION SURGERY HAS BEEN SCHEDULED FOR AUGUST 28, 1997.

    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 6 YR