BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 99857 · Received June 17, 1997

    Report

    Report Number
    2029203-1997-00009
    Event Type
    Other
    Date Received
    June 17, 1997
    Date of Event
    October 1, 1996
    Report Date
    May 15, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIDENTIALITY: ADVANCED BIONICS CORPORATION BELIEVES THAT DISCLOSURE OF INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS CORPORATION SUBMITS THIS INFO IN CONFIDENCE EXPECTING FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF THE FREEDOM OF INFORMATION ACT. WE BELIEVE THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF THE CRIMINAL LAW (18 U.S.C. SECTION 1905). SECTION 6 - DEVICE EVALUATION CONSISTED OF FOLLOWING: A REVIEW OF DEVICE HISTORY RECORD (DHR); VISUAL EXAMINATION; X-RAY EXAMINATION; ELECTRICAL TESTING. SECTION 6 - THE CASE WAS FOUND TO BE FRACTURED. CRACKED CASE ALLOWED INSTRUSION OF FLUIDS INTO ICS CAVITY RESULTING IN ELECTRICAL FAILURE. VISUAL EXAMINATION: VISUAL EXAMINATION REVEALED THAT CRACK WAS PRESENT ORIGINATING AT CASE BAND AND TRAVELING DOWN ROUNDED EDGE OF CASE APPROXIMATELY ONE HALF INCH. THIS CRACK WAS SMALL AND NOT EASILY DETECTED. ELECTRODE WAS INTACT AND WAS NORMAL IN APPEARANCE. NO OTHER DEFECTS WERE NOTED. BRIGHT LIGHT EXAMINATION; NOT PERFORMED SINCE X-RAY EXAMINATION WAS PERFORMED. X-RAY EXAMINATION; X-RAY EXAMINATION DID NOT DETECT PRESENCE OF ANY CRACKS IN SUBSTRATE OR LOOSE COMPONENTS. ELECTRICAL TESTING; DRY PCIT TESTING RESULTED IN VERIFICATION THAT "NO LINK" COULD BE ESTABLISHED WITH THIS DEVICE. CASE HERMETICITY TESTING (LEAK TESTING); NOT PERFORMED, SINCE CASE WAS CRACKED AND HERMETICITY HAS ALREADY BEEN COMPROMISED. CASE REMOVAL; NOT PERFORMED, SINCE CASE WAS CRACKED. INTERNAL VISUAL EXAMINATION; NOT PERFORMED, SINCE X-RAY EXAMINATION WAS PERFORMED. INTERNAL ELECTRICAL TESTING; NOT PERFORMED, SINCE CASE WAS CRACKED. CONCLUSION: FAILURE OF THIS ICS IS ATTRIBUTED TO CRACKED CASE AND LOSS OF HERMETIC SEAL. CRACKED CASE ALLOWED INTRUSION OF FLUIDS INTO ICS CAVITY RESULTING IN ELECTRICAL FAILURE. THIS DEVICE TOOK SEVEN MONTHS FROM TIME OF TRAUMA THAT INDUCED CRACK IN HEADPIECE UNTIL ITS FUNCTION WAS LOST. THIS IN IN AGREEMENT WITH SIZE AND SEVEITY OF CRACK DISCOVERED. CORRECTIVE ACTION: CERAMIC CASE USED IN THIS DEVICE WAS MANUFACTURED USING ISOPRESS MFG PROCESS. BECAUSE OF PREVIOUS INSTANCES OF CASE DAMAGE IN PEDIATRIC POPULATION, ADVANCED BIONICS HAS TERMINATED USAGE CASES MANUFACTURED USING ISOPRESS IN FAVOR OF CASES MANUFACTURED USING INJECTION MOLDING PROCESS. ADVANCED BIONICS HAS ALSO DEVELOPED AND IMPLEMENTED A SCREENING PROCEDURE TO ASSURE THAT CASE LOTS ACCEPTED POSSES UNIFORM MINIMUM CASE STRENGTH TO INCREASE THEIR ABILITY TO WITHSTAND GREATER IMPACT LEVELS.

    Description of Event or Problem · 1

    PT WAS IMPLANTED IN SEPTEMBER 1996, WITH NO DIFFICUTIES ENCOUNTERED. APPROXIMATELY ONE MONTH POST IMPLANTATION HE WAS ATTACKED BY A NEIGHBOR'S DOG WHILE IN HIS FRONT YARD. THE ATTACK KNOCKED HIM BACKWARD ONTO THE GROUND. HE STRUCK THE BACK OF HIS HEAD ON THE CONCRETE BUT DID NOT LOSE CONSCIOUSNESS. PT STATED HE DID NOT HIT HIS IMPLANT AREA AT ALL DURING THE FALL. HE WAS SEEN AT THE IMPLANT CENTER SHORTLY THEREAFTER. CTS WERE TAKEN AND THE SURGEON WHO REVIEWED THE SCANS REPORTED THAT NO ABNORMALITIES WERE OBSERVED. THE PT HAS STATED THAT THERE HAVE BEEN NO FURTHER IMPACTS TO THE HEAD SINCE THE OCTOBER INCIDENT. APPROXIMATELY 6 WEEKS PRIOR TO LOSS OF DEVICE FUNCTION, PT WAS SEEN AT THE CENTER FOR A ROUTINE DEVICE EVALUATION. ALTHOUGH THE PT DID NOT EXPERIENCE ANY CHANGE IN PERFORMANCE PRIOR TO THIS, HIGH ELECTRODE IMPEDANCE READINGS WERE OBSERVED. HIS PERFORMANCE CONTINUED TO BE UNCHANGED UNTIL MAY 9. 1997, WHEN HIS DEVICE CEASED FUNCTIONING ENTIRELY. PT WENT TO THE IMPACT CENTER ON MAY 12,1997, WHERE LOSS OF LINK WAS CONFIRMED USING THE PORTABLE COCHLEAR IMPLANT TESTER, SCLIN 4W, VARIOUS HEADPIECES AND A DIFFERENT SPEECH PROCESSOR. REVISION SURGERY TOOK PLACE ON MAY 20, 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 * Other