BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 97239 · Received June 6, 1997

    Report

    Report Number
    2029203-1997-00008
    Event Type
    Other
    Date Received
    June 6, 1997
    Date of Event
    April 1, 1997
    Report Date
    April 24, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS CORPORATION SUBMITS THIS INFO IN CONFIDENCE EXPECTING THAT FDA OF FREEDOM OF INFO ACT. CO BELIEVES THAT ANY DISCLOSURE OF INFO BY FEDERAL EMPLOYEE COULD CONSTITUTE VIOLATION OF CRIMINAL LAW (18 U.S.C. SECTION 1905). DEVICE EVALUATION CONSISTED OF FOLLOWING: REVIEW OF DEVICE HISTORY RECORD (DHR), VISUAL EXAMINATION, ELECTRICAL TESTING, LEAK TESTING (HERMETICITY) AND X-RAY EXAMINATION. CASE WAS FOUND TO BE CRACKED. CRACKED CASE ALLOWED THE INTRUSION OF FLUIDS INTO ICS CAVITY RESULTING IN ELECTRICAL FAILURE. ALTHOUGH FAILURE TO LOCK OBSERVATION NOTED IN REPORT FROM CLINIC WAS NOT VERIFIED DURING CO'S TESTING, IT IS BELIEVED THAT THIS DEVICE WAS INOPERATIVE AT TIME OF EXPLANT. EARLY TESTING AFTER SEVENDAY SOAK IN SALINE SOLUTION DID INDICATE THAT MOISTURE WAS ENTERING DEVICE AND CAUSING ELECTRICAL ANOMALIES. TESTING RESULTS ALONG WITH THIS DEVICE'S FAILURE OF GROSS LEAT TEST INDICATE THAT DIRECT CAUSE OF THIS DEVICE'S FAILURE WAS CRACKED AND LOSS OF HERMETICITY. THIS ALLOWED FLUID INSTRUSION AND SUBSEQUENT DEVICE MALFUNCTION. 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 IN PEDIATRIC POPULATION, ADVANCED BIONICS HAS TERMINATED USAGE OF CASED MFG USING ISOPRESS PROCESS IN FAVOR OF CASES MFG USING INJECTION MOLDING PROCESS. ADVANCED BIONICS HAS ALSO DEVELOPED AND IMPLEMENTED SCREENING PROCEDURE TO ASSURE THAT CASE LOTS ACCEPTED POSSESS UNIFORM MINIMUM CASE STRENGTH TO INCREASE THERI ABILITY TO WITHSTAND GREATER IMPACT LEVELS EXPERIENCED BY PEDIATRIC POPULATION. DURING VISUAL EXAMINATION FOUR CRACKS WERE FOUND ON CERAMIC CASE OF THIS DEVICE. THREE CRAKS ARE LOCATED ON LEFT SIDE OF DEVICE WHEN VIEWED FROM SIDE FACING OUT AND ONE IS ON RIGHT SIDE. TWO OF THREE CRACK ON LEFT SIDE EXTEND APPROXIMATELY ONE QUARTER OF INCH FROM CASE BAND AND JOIN ON FRONT SIDE OF CASE. OTHER CRACK LOCATED ON LEFT SIDE OF CASE EXTENDS FROM CASE BAND ON ROUNDED AREA ALONG MOLD LINE FOR APPROXIMATELY ONE HALF INCH. FOURTH CRACK IS LOCATED ON RIGHT SIDE OF FRONT OF CASE. IT EXTENDS FROM CASE BAND APPROXIMATELY ONE HALF INCH TOWARD CENTER OF CASE FACE. ELECTRODE WAS INTACT WHEN RECEIVED AND APPEARED NORMAL. BRIGHT LIGHT EXAMINATION WAS NOT PERFORMED SINCE X-RAY EXAMINATION WAS PERFORMED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO CURRENTLY AVAILABLE, A 17.5 YR-OLD GIRL, REPORTED THAT HER IMPLANT SYSTEM CEASED FUNCTIONING SOMETIME DURING THE WEEK OF 4/13/97. SHE WAS SEEN AT THE IMPLANT CENTER ON 4/21/97, FOR A COMPLETE DEVICE EVAL. ATTEMPTS TO OBTAIN LINK USING THE PORTABLE COCHLEAR IMPLANT TESTER (PCIT) WERE UNSUCCESSFUL. EXPLANTATION WAS RECOMMENDED AND REVISION SURGERY WAS SCHEDULED FOR 5/12/97.

    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 17 YR Other