BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 120097 · Received September 10, 1997

    Report

    Report Number
    2029203-1997-00019
    Event Type
    Other
    Date Received
    September 10, 1997
    Date of Event
    August 18, 1997
    Report Date
    August 18, 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 THE INFO REGARDING DEVICE EVALUATION COULD SUBSTANIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS CORP SUBMITS THIS INFO IN CONFIDENCE EXPECTIONG THAT FDA WILL WITHHOLD IT UNDER EXEMPTION 4 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 (HERMETICIY), CASE REMOVAL AND X-RAY EXAMINATION. CAUSE OF FAILURE HAS BEEN IDENTIFIED AS BROKEN SUBSTRATE. SOURCE OF CRACK IN SUBSTRATE HAS NOT BEE IDENTIFIED. ANALYSIS OF ICS FAILURE RECORDS INDICATES THAT FAILURE MODE EXPERIENCED BY THIS DEVICE IS UNIQUE AND CONSIDERED RANDOM. CAUSE OF THIS DEVICE'S FAILURE WAS BROKEN SUBSTRATE. IT IS NOT CLEAR WHEN SUBSTRATE CRACKED. ONLY TEST THAT IS CAPABLE OF DETECTING THIS FAILURE MODE IS ELECTRODE ELECTRICAL TEST DEFINED IN CTP-1058. LAST TIME THIS DEVICE PASSED THIS TEST WAS ON 2/16/1997, JUST BEFORE FINAL PAKAGING AND STERILIZATION. ALL SUBSEQUENT TESTING WAS PERFORMED IN ACCORDANCE WITH CTP-1008, TEST 11, WHICH ONLY TESTS FUNCTIONALITY OF HYBRID PORTION OF DEVICE. TEST 11 IS PERFORMED AT PACKAGED LEVEL OF ASSEMBLY AND BEYOND. REVIEW OF FAILURE HISTORY FOR THIS UNIT DID NOT INDICATE THAT THIS DEVICE EXPERIENCED ANY UNUSUAL HANDLING OR EXCESSIVE REMOVALS FROM CASE BAND ASSEMBLY PRIOR TO FINAL ACCEPTANCE. IT IS UNLIKELY THAT THIS CRACK WAS PRESENT DURING INITIAL BUILD OF THIS DEVICE SINCE THIS DEVICE PASSED ALL ENVIRONMENTAL SCREENING TESTS INCLUDING TEMPERATURE CYCLING AND VIBRATION. POSSIBLE SCENARIO WOULD INVOLVE EXCESSIVE SIDE LOADS BEING APPLIED TO SUBSTRATE DUE TO SLIGHT MISALIGNMENT OF SUBSTRATE TO HEADER. THIS CONDITION COULD HAVE RESULTED IN A SIDE LOAD, WHICH COULD RESULT IN FORMATION OF MICRO-CRACKS. THESE MICRO-CRACKS COULD THEN PROPAGATE UNDER TEMPERATURE CYCLING OR VIBRATION. HOWEVER, ONCE DEVICE IS IMPLANTED THESE ENVIRONMENTAL CONDITIONS WOULD NOT BE PRESENT. DUE TO THE CONDITION OF MATING SURFACES AT SUBSTRATE CRACK SITE IS NOT POSSIBLE TO RECONSTRUCT AND MEASURE THIS DEVICE'S SUBSTRATE TO HEADER PERPENDICULARITY. SINCE SOURCE OF CRACK IN SUBSTRATE HAS NOT BEEN IDENTIFIED, NO CORRECTIVE ACTION IS POSSIBLE. HOWEVER, AS PART OF CONTINUOUS IMPROVEMENT EFFORTS, UPGRADES IN TOOLING UTILIZED TO ESTABLISH AND MAINTAIN PERPENDICULARITY BETWEEN SUBSTRATE AND HEADER ASSEMBLIES HAVE BEEN MADE OVER LAST FEW MONTHS. FURTHER, ANALYSIS OF ICS FAILURE RECORDS INDICATE THAT FAILURE MODE EXPERIENCED BY THIS DEVICE IS UNIQUE AND CONSIDERED RANDOM. EXTERNAL VCISUAL EXAMINATION DID NOT REVEAL ANY DAMAGE TO DEVICE. ICS CASE WAS INTACT AND IN EXCELLENT CONDITION, AND ELECTRODE WAS INTACT AND IN GOOD CONDITION. IT WAS NOTED DURING HANDLING OF THIS DEVICE DURING VISUAL EXAMINATION THAT SOMETHING WAS LOOSE INSIDE THE HYBRID CASE.

    Description of Event or Problem · 1

    A 10 YEAR-OLD GIRL, WAS ORIGINALLY IMPLANTED ON 3/26/1997. PCIT TESTING PERFORMED INTRAOPERATIVELY REVEALED THAT 3 ELECTRODES HAD READINGS OF 999K. BECAUSE THERE HAD BEEN NO SURGICAL COMPLICATIONS OR PROBLEMS WITH PARTIAL INSERTION OF THE ELECTRODE ARRAY, THE IMPLANTING SURGEON ELECTED TO PROCEED WITH IMPLANTATION AND CLOSURE. BECAUSE THE IMPEDANCE VALUES HAD NOT CHANGED AT THE TIME OF INITIAL DEVICE FITTING, THE DECISION WAS MADE TO CLOSELY MONITOR THE PT'S PERFORMANCE. WHEN SEEN AT THE IMPLANT CENTER IN EARLY JULY, ADD'L ELECTRODES WERE NOW EXHIBITING 999K READINGS AND IT WAS SUGGESTED TO HER FAMILY THAT SHE REPROGRAMMED TO A 5-CHANNEL PROGRAM. ALTHOUGH A 5-CHANNEL PROGRAM HAS BEEN SUCCESSFULLY USED BY THE IMPLANT CENTER IN THE PAST, THE GIRL'S FAMILY REQUESTED THAT THEIR DAUGHTER'S IMPLANT BE REMOVED AND REPLACED WITH ANOTHER CLARION DEVICE, REVISION SURGERY WILL TAKE PLACE ON 9/17/97.

    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 10 YR