BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 108684 · Received July 25, 1997

    Report

    Report Number
    2029203-1997-00013
    Event Type
    Other
    Date Received
    July 25, 1997
    Date of Event
    July 9, 1997
    Report Date
    July 10, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION D.8 THE DATE OF EXPLANT WAS REPORTED AS 7/22/97. IT ACTUALLY TOOK PLACE ON 8/7/97. SECTION H.6 DEVICE EVALUATION CONSISTED OF THE FOLLOWING: A REVIEW OF THE DEVICE HISTORY RECORD (DHR); VISUAL EXAMINATION; X-RAY EXAMINATION; ELECTRICAL TESTING. 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 EXPERIENCED PRIOR TO FAILURE: ON 7/10/97, PT WAS REPORTED TO HAVE EXPERIENCED FALL IN WHICH NO IMPACT IN IMPLANT AREA WAS BELIEVED TO HAVE OCCURRED. THIS FALL WAS NOT WITNESSED. PT THEN EXPERIENCED LOSS OF LINK WITH IMPLANTED DEVICE. AT TIME OF FALL PT WAS NOT WEARRING HIS PROTECTIVE HEADPIECE COVER. PHYSICAL EXAMINATION OF PT JUST AFTER FALL DID NOT INDICATE THAT ANY TRAUMA HAD BEEN SUSTAINED IN IMPLANT AREA. CENTER ATTEMPTED TO OBTAIN LINK WITH 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 ELECTRODE WAS CUT MID-SPAN BY SURGEON TO FACILITATE DEVICE REMOVAL. ALL PIECES OF ELECTRODE WERE REVISED. INSPECTION OF ELECTRODE DETERMINED THAT ELECTRODE WAS NORMAL AND IN GOOD CONDITION AT TIME OF EXPLANT. BRIGHT LIGHT EXAMINATION: WAS NOT PERFORMED SINCE X-RAY EXAMINATION WAS PERFORMED. X-RAY EXAMINATION: X-RAY EXAMINATION DID NOT REVEAL PRESENCE OF ANY INTERNAL DAMAGE TO HYBRID DEVICE. ELECTRICAL TESTING: ELECTRICAL TESTING: ELECTRICAL TESTING WAS NOT PERFORMED DUE TO CONDITION OF DEVICE. CASE HERMETICITY TESTING (LEAK TESTIN): LEAK TESTING WAS NOT PERFORMED DUE TO CONDITION OF DEVICE. CASE REMOVAL: CASE REMOVAL WAS NOT PERFORMED DUE TO CONDITION OF DEVICE. INTERNAL VISUAL EXAMINATION: INTERNAL VISUAL EXAMINATION WAS NOT PERFORMED DUE TO CONDITION OF DEVICE. CONCLUSION: FAILURE OF THIS ICS IS ATTRIBUTED TO CRACKED CASE AND LOSS OF HERMETIC SEAL. CRACKED CASE ALLOWED THE INSTRUSION OF FLUIDS INTO THE ICS CAVITY RESULTING IN ELECTRICAL FAILURE. CORRECTIVE ACTION: CERAMIC CASE USED IN THIS DEVICE WAS MANUFACTURED USING ISOPRESS MFG PROCESS. ADVANCED BIONICS HAS DETERMINED THAT CASES MANUFACTURED USING ISOPRESS PROCESS ARE LESS RESISTANT TO IMPACT DAMAGE THAN CASES MANUFACTURED USING INJECTION MOLDING PROCESS. BECAUSE OF PREVIOUS INSTANCES OF CASE DAMAGE IN PEDIATRIC POPULATION, ADVANCED BIONICS HAS TERMINATED USAGE OF CASES MANUFACTURED USING ISOPRESS PROCESS IN FAVOR OF CASES MANUFACTURED USING INJECTION MODLING PROCESS. ADVANCED BIONICS HAS ALSO DEVELOPED AND IMPLEMENTED SCREENING PROCEDURE TO ASSURE THAT CASE LOTS ACCEPTED POSSES UNIFORM MINIMUM STRENGTH TO INCREASE THEIR ABILITY TO WITHSTAND GREATER IMPACT LEVELS EXPERIENCED BY PEDIATRIC POPULATION.

    Description of Event or Problem · 1

    A 4 YEAR OLD BOY, FELL DOWN ON JULY 9, 1997. ALTHOUGH NO ONE SAW HIM FALL, THE PT STATED THAT HE DID NOT HIT HIS HEAD. HIS FAMILY TOOK HIM TO THE IMPLANT CENTER THE NEXT DAY, JULY 10, 1997, BECAUSE HIS DEVICE HAD STOPPED WORKING. THE SURGEON WHO EVALUATED THE PATIENT REPORTED THAT SHE SAW NOTHING ON THE SKIN OVER THE IMPLANT SITE THAT INDICATED AN IMPACT. SHE ALSO PALPATED THE AREA OVER THE IMPLANT BUT DID NOT DETECT ANYTHING ABNORMAL. IN AN ATTEMPT TO ESTABLISH LINK BETWEEN THE INTERNAL AND EXTERNAL COMPONENTS OF THE SYSTEM, THE PT'S HEADPIECE, CABLE, AND SPEECH PROCESSOR WERE EXCHANGED. HOWEVER, TESTING WITH THE PORTABLE COCHLEAR IMPLANT TESTER (PCIT) CONFIRMED THE DEVICE HAD CEASED FUNCTIONING. REVISION SURGERY IS PENDING.

    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