BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 121887 · Received September 17, 1997

    Report

    Report Number
    2029203-1997-00020
    Event Type
    Other
    Date Received
    September 17, 1997
    Date of Event
    August 20, 1997
    Report Date
    August 28, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS BELIEVES THAT DISCLOSURE OF INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS CORPORATION SUBMITS THIS INFO IN CONFIDENCE EXPECTING THAT FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF THE FREEDOM OF INFORMATION ACT. CO BELIEVES THAT ANY DISCLOSURE OF THE INFO BY FEDERAL EMPLOYEE COULD CONSTITUTE A 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, AND X-RAY EXAMINATION. MALFUNCTION WAS IDENTIFIED AS BROKEN WIRES IN FANTAIL REGION OF ELECTRODE. CAUSE OF FAILURE HAS BEEN TRACED TO SEVERAL ANOMALIES CONCERNING ORIGINAL IMPLANT SURGICAL TECHNIQUE. CAUSE OF THIS DEVICE'S FAILURE WAS BROKEN WIRES IN FANTAIL REGION OF ELECTRODE. SOME OF WIRE FRACTURES APPEAR TO BE CAUSED BY A TENSILE OVERLOAD WHILE OTHERS APPEAR TO BE FATIGUE INDUCED FAILURES. TYPE OF BREAKS OBSERVED IN THIS INSTANCE MAY HAVE BEEN RESULT OF TENSILE LOAD BEING APPLIED TO SOME OF ELECTRODE WIRES AND BENDING STRESSES TO OTHERS. ATTENDING ADVANCED BIONICS ENGINEER OBSERVED THAT ORIGINAL IMPLANT SURGERY DID NOT INCLUDE FIXING DEVICE INTO BONY RECESS WITH NON-DISSOLVING SUTURES. IT WAS ALSO REPORTED THAT CAVITY CREATED TO HOLD DEVICE WAS TOO WIDE ALLOWING SIDE BY SIDE PLAY IN EXCESS OF QUARTER OF AN INCH. RELATIVE POSITION OF CENTER OF CAVITY WITH RESPECT TO ENTRANCE INTO INNER EAR BIASED ICS LOCATION TOWARD TOP OF RECESS ALLOWING MOVEMENT OF ROUNDED PORTION OF ICS CASE WITH RESPECT TO ELECTRODE FANTAIL. ALL OF THESE CONDITIONS LED TO LARGE AMOUNT OF MOBILITY OF ICS CASE AFTER IMPLANT SURGERY. UNDER CONDITIONS OBSERVED DEVICE WOULD BE ABLE TO MOVE FROM SIDE TO SIDE IN LATERAL MOTION WITH ELECTRODE WIRES FIXED BY THEIR ENTRY INTO INNER EAR. THIS COMBINATION OF CIRCUMSTANCES WOULD RESULT IN HIGHER THAN NORMAL BENDING AND TENSION FORCES BEING APPLIED TO ICS FANTAIL REGION OF ELECTRODE. THIS DEVICE MOBILITY IS THE DIRECT CAUSE OF THESE ELECTRODE WIRE FAILURES. THE CAUSE OF THIS FAILURE HAS BEEN TRACED TO SEVERAL ANOMALIES CONCERNING ORIGINAL IMPLANT SURGICAL TECHNIQUE. HOWEVER, ADVANCED BIONICS IS CONTINUING TO INVESTIGATE METHODS TO INCREASE ELECTRODE'S ABILITY TO WITHSTAND CYCLIC FLEX LOADS. EXTERNAL VISUAL EXAMINATION DID NOT REVEAL ANY DAMAGE TO DEVICE. ICS CASE WAS INTACT IN EXCELLENT CONDITION, AND ELECTRODE WAS INTACT AND IN GOOD CONDITION. BRIGHT LIGHT EXAMINATION WAS NOT PERFORMED SINCE X-RAY INSPECTION WAS PERFORMED. X-RAY EXAMINATION DID NOT REVEAL ANY INTERNAL DAMAGE TO ICS RECEIVED. HOWEVER EIGHT ELECTRODE WIRES IN FANTAIL REGION WERE FOUND BROKEN. BREAKS WERE ALL LOCATED IN WIDE PART OF FANTAIL NEAR POTTED AREA JUST INSIDE FANTAIL CASTING. SOME OF BREAKS APPEAR TO BE TENSILE OVERSTRESS. WET ELECTRICAL TESTING WAS PERFORMED UPON RECEIPT, WHICH VERIFIED HIGH IMPEDANCE MEASUREMENTS, REPORTED FROM CLINIC. DEVICE ACHIEVED LOCK.

    Description of Event or Problem · 1

    WHEN TESTED INTRAOPERATIVELY WITH THE PORTABLE COCHLEAR IMPLANT TESTER (PCIT), THE READINGS INDICATED NOMINAL VALUES FOR ALL 16 ELECTRODES. HOWEVER, OVER THE COURSE OF THE NEXT FIVE MOS, THE NUMBER OF ELECTRODES EXHIBITING HIGH IMPEDANCES CONTINUED TO INCREASE AND WHEN THE PT WAS SEEN AT THE IMPLANT CENTER ON AUGUST 28, 1997 FOR DEVICE EVAL, THE TOTAL NUMBER OF ELECTRODES WITH A 999K VALUE HAD RISEN TO EIGHT. WITH ONLY 4 CHANNELS FUNCTIONAL ON THEIR SON'S SYSTEM THE PARENTS REQUESTED-WITH THE CONCURRENCE OF ADVANCED BIONICS-THAT THE DEVICE BE EXPLANTED. REVISION SURGERY IS SCHEDULED FOR SEPTEMBER 30, 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 3 YR