BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 169242 · Received May 20, 1998

    Report

    Report Number
    2029203-1998-00013
    Event Type
    Malfunction
    Date Received
    May 20, 1998
    Date of Event
    April 24, 1998
    Report Date
    April 27, 1998
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIDENTIALITY: ADVANCED BIONICS BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS SUBMITS THIS INFO IN CONFIDENCE EXPECTING FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF FREEDOM IN INFO ACT. WE BELIEVE THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF CRIMINAL LOW (18 U.S.C. SECTION 1905) SECTION H.6 - DEVICE EVALUATION CONSISTED OF: A REVIEW OF DEVICE HISTORY RECORD (DHR); VISUAL EXAMINATION, X-RAY EXAMINATION; AND ELECTRICAL TESTING. SECTION H.6 - DEVICE FAILURE WAS ATTRIBUTED TO A CRACKED CASE. THIS CRACK ALLOWED MOISTURE TO ENTER DEVICE OVER TIME RESULTING IN CORROSION OF INTERNAL COMPONENTS WHICH CAUSE DEVICE TO CEASE FUNCTIONING. PLEASE REFER TO ATTACHED DEVICE FAILURE ANALYSIS REPORT. BACKGROUND: PT WAS ORIGINALLY IMPLANTED ON 8/15/1996 AND SUCCESSFULLY FITTED. HIS SYSTEM FUNCTIONED NORMALLY FROM TIME OF HIS INITIAL DEVICE FITTING THROUGHOUT NEXT 20 MONTHS. ON 4/24/1998, PT BEGAN EXPERIENCING PROBLEM WITH INTERMITTENT LINK. PT WENT TO IMPLANT CENTER ON 4/27/1998 FOR DEVICE EVAL. TESTING PERFORMED AT CENTER DID NOT REVEAL ANY PROBLEMS WITH HIS SYSTEM. LINK WAS ACHIEVED AND HE LEFT CENTER WITH BOTH INTERNAL AND EXTERNAL COMPONENTS OF HIS SYSTEM FUNCTIONING NORMALLY. THAT SAME EVENING PT'S WIFE CALLED CENTER TO REPORT THAT DEVICE HAD STOPPED WORKING AND THAT HER HUSBAND COULD NO LONGER HEAR. NEXT DAY, 4/28/1998, PT WAS SEEN AT ADVANCED BIONICS WHERE EXTENSIVE TROUBLESHOOTING CONFIRMED THAT HIS DEVICE WAS NO LONGER FUNCTIONING. REVISION SURGERY TOOK PLACE ON 5/6/1998. REVIEW OF DEVICE HISTORY RECORD (DHR): MFG START: 9/8/1995. MFG END: 11/2/1995. VISUAL EXAMINATION: VISUAL EXAMINATION REVEALED THAT ONE HAIRLINE CRACK WAS PRESENT ON FRONT SIDE OF DEVICE CASE. IT BEGAN AT CASE BAND AND CIRCLED ALONG INTERFACE BETWEEN FLAT AND ROUNDED SURFACES OF CASE ALL WAY ACROSS CASE. ELECTRODE WAS INTACT AND IN GOOD CONDITION. ALL ELECTRODE BALLS WERE IN PLACE AND IN GOOD CONDITION. BRIGHT LIGHT EXAMINATION: WAS NOT PERFORMED SINCE X-RAY EXAMINATION WAS PERFORMED. X-RAY EXAMINATION: X-RAY EXAMINATION REVEALED NO ANOMALIES INSIDE DEVICE. ELECTRICAL TESTING: ELECTRICAL TESTING WITH PCIT VERIFIED THAT LINK COULD NOT BE ESTABLISHED WITH THIS DEVICE. CASE HERMETICITY TESTING (LEAK TESTING): LEAK TESTING WAS NOT PERFORMED SINCE CRACK WAS FOUND ON THIS DEVICE. CASE REMOVAL: CASE REMOVAL WAS NOT PERFORMED SINCE THE CASE WAS CRACKED AND HERMETIC SEAL WAS LOST ALLOWING MOISTURE INTO DEVICE. INTERNAL VISUAL EXAMINATION: INTERNAL VISUAL EXAMINATION WAS NOT PERFORMED SINCE THE CASE WAS CRACKED AND HERMETIC SEAL WAS LOST ALLOWING MOISTURE INTO DEVICE. INTERNAL ELECTRICAL TESTING: INTERNAL ELECTRICAL TESTING WAS NOT PERFORMED SINCE CASE WAS CRACKED AND HERMETIC SEAL WAS LOST ALLOWING MOISTURE INTO DEVICE. CONCLUSION: FAILURE OF THIS ICS IS ATTRIBUTED TO CRACKED CASE. THIS CRACK ALLOWED MOISTURE TO ENTER THIS DEVICE OVER TIME. THIS MOISTURE CAUSED CORROSION OF INTERNAL COMPONENTS WHICH CAUSED THIS DEVICE TO CEASE FUNCTIONING. ALTHOUGH NO IMPACE TO IMPLANT SITE WAS REPORTED, CRACK WAS MOST LIKELY RESULTED FROM ONE AT THAT SITE. CORRECTIVE ACTION: CERAMIC CASE USED IN THIS DEVICE WAS MFG USING ISOPRESS MFG PROCESS. ADVANCED BIONICS HAS DETERMINED THAT CASES MFG USING THE ISOPRESS PROCESS ARE LESS RESISTANT TO IMPACT DAMAGE THAN CASES MFG USING INJECTION MOLDING PROCESS. ISOPRESS CASES WERE DISCONTINUED IN FAVOR OF INJECTION MOLDED CASES. IN ADDITION, CONTINUOUS EFFORTS HAVE RESULTED IN DEVELOPMENT OF STRONGER CASES THROUGH DESIGN AND PROCESS PARAMETER OPTIMIZATION. MORE THAN 50% INCREASE IN AVERAGE STATIC STRENGTH HAS BEEN ACHIEVED TO DATE, WHICH HAVE LED TO FURTHER REDUCTION OF CASE FRACTURES.

    Description of Event or Problem · 1

    A 37 YEAR-OLD MALE, WAS ORIGINALLY IMPLANTED ON AUGUST 15, 1996. HIS SYSTEM FUNCTIONED NORMALLY FROM THE TIME OF HIS INITIAL DEVICE FITTING THROUGHOUT THE NEXT 20 MONTHS. ON APRIL 24, 1998, THE PT BEGAN EXPERIENCING A PROBLEM WITH INTERMITTENT LINK, PT WENT TO THE IMPLANT CENTER ON APRIL 27, FOR DEVICE EVALUATION. TESTING PERFORMED AT THE CENTER DID NOT REVEAL ANY PROBLEMS WITH HIS SYSTEM. LINK WAS ACHIEVED AND HE LEFT THE CENTER WITH BOTH THE INTERNAL AND EXTERNAL COMPONENTS OF HIS SYSTEM FUNCTIONING NORMALLY. THAT SAME EVENING, PT'S WIFE CALLED THE CENTER TO REPORT THAT THE DEVICE HAD STOPPED WORKING AND THAT HER HUSBAND COULD NO LONGER HEAR. THE NEXT DAY, APRIL 28, 1998, PT WAS SEEN AT ADVANCED BIONICS WHERE EXTENSIVE TROUBLE-SHOOTING CONFIRMED THAT HIS DEVICE WAS NO LONGER FUNCTIONING. REVISION SURGERY WAS ON MAY 6, 1998. PT WAS REIMPLANTED WITH ANOTHER CLARION DEVICE.

    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 37 YR