BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 121558 · Received September 16, 1997

    Report

    Report Number
    2029203-1997-00018
    Event Type
    Other
    Date Received
    September 16, 1997
    Date of Event
    August 22, 1997
    Report Date
    August 22, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H.6 - DEVICE EVALUATION CONSISTED OF A REVIEW OF THE DEVICE HISTORY RECORD AND VISUAL EXAMINATION. SECTION H.6 - THE FAILURE OF THE DEVICE WAS FOUND TO BE A CRACKED CASE AND BROKEN HYBRID SUBSTRATE. BOTH WERE THE RESULT OF IMPACT AT THE IMPLANT SITE. REFER TO ATTACHED DEVICE FAILURE ANALYSIS REPORT FOR DETAILED INFO. PT EXPERIENCE PRIOR TO FAILURE: THE FAMILY REPORTED THAT THE SPEECH PROCESSOR LED STARTED TO BLINK WHILE THE PT WAS AT DAYCARE ON 8/22/97. THERE WAS NO REPORT OF ANY IMPACTS IN THE HEADPIECE AREA. THE CENTER ATTEMPTED TO OBTAIN LINK WITH THE IMPLANT BY SWAPPING EXTERNAL EQUIPMENT BUT WAS UNSUCCESSFUL. REVISION SURGERY WAS SCHEDULED. VISUAL EXAMINATION: INTIAL VISUAL EXAMINATION REVEALED THAT THE CASE HAD SUSTAINED MANY CRACKS. THE HYBRID WAS SEPARATED FROM THE CASE BAND ASSEMBLY. THE ELECTRODE WAS UNCUT AS RECEIVED. INSPECTION OF THE ELECTRODE DETERMINED THAT THE ELECTRODE WAS NORMAL AND IN GOOD CONDITION AT THE TIME OF THE EXPLANT. BRIGHT LIGHT EXAMINATION: BRIGHT LIGHT EXAMINATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. X-RAY EXAMINATION: X-RAY EXAMINATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. ELECTRICAL TESTING: ELECTRICAL TESING WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. CASE HERMETICITY TESTING (LEAK TESTING): LEAK TESTING WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. CASE REMOVAL: CASE REMOVAL WAS NOT NECESSARY 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 ATTIBUTED TO THE CRACKED CASE AND BROKEN HYBRID SUBSTRATE CAUSED BY AN IMPACT AT THE IMPLANT SITE. THIS INDUCED THE LOSS OF HERMETIC SEAL AND FLUID INTRUSION, AND THE ACCOMPANYING BROKEN SUSTRATE THAT RESULTED IN THE LOSS OF ELECTRICAL CONTINUITY TO THE ELECTRODE. CORRECTIVE ACTION: THE CERAMIC CASE USED IN THIS DEVICE WAS MANUFACTURED USING THE ISOPRESS MFG PROCESS. ADVANCED BIONICS HAS DETERMINED THAT CASES MANUFACTURED USING THE ISOPRESS PROCESS ARE LESS RESISTANT TO IMPACT DAMAGE THAN CASES MANUFACTURED USING THE INJECION 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 PROCESS 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 UNIFOM MINIMUM CASE STRENGTH TO INCREASE THEIR ABILITY TO WITHSTAND THE GREATER IMPACT LEVELS EXPERIENCED BY THE PEDIATRIC POPULATION.

    Description of Event or Problem · 1

    AN INDIVIDUAL WAS IN DAYCARE WHEN THEIR SPEECH PROCESSOR'S LED BEGAN BLINKING. THE PARENTS TRIED TO ANOTHER HEADPIECE AND CABLE, BUT THE BLINKING (AN INDICATION THE SPEECH PROCESSOR WAS UNABLE TO COMMUNICATE WITH THE IMPLANT) CONTINUED. THE PARENTS CONTACTED THE IMPLANT CENTER THE FOLLOWING DAY AND TOOK THEIR CHILD IN FOR AN EVALUATION. AT THE CENTER, ATTEMPTS TO ACHIEVE "LINK" WITH A DIFFERENT SPEECH PROCESSOR WERE UNSUCCESSFUL AND "NO LINK" WAS OBSERVED DURING TESTING WITH THE PORTABLE COCHLEAR IMPLANT TESTER (PCIT). THE CENTER THEN CONTACTED ADVANCED BIONICS AND AFTER DISCUSSING THE SITUATION, EXPLANTATION/REIMPLANTATION WAS RECOMMENDED. REVISION SURGERY HAS BEEN SCHEDULED.

    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 3 YR