BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 162776 · Received April 9, 1998

    Report

    Report Number
    2029203-1998-00005
    Event Type
    Other
    Date Received
    April 9, 1998
    Date of Event
    March 1, 1998
    Report Date
    March 11, 1998
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIDENTIALITY: ADVANCED BIONICS BELIEVES THAT DISCLOSURE OF INFO REGARDING DEVICE EVAL COULD SUBSTANTIALLY HARM IT COMPETITIVE POSITION. ADVANCED BIONICS SUBMITS THIS INFO IN CONFIDENCE EXPECTING FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF FREEDOM OF INFFO ACT. CO BELIEVES THAT ANY DISCLOSURE OF INFO BY FEDERAL EMPLOYEE COULD CONSTITUTE VIOLATION OF CRIMINAL LAW (18 U.S.C. SECTION 1905) DEVICE EVAL CONSISTED OF: REVIEW OF DEVICE HISTORY RECORD (DHR); VISUAL EXAMINATION, X-RAY EXAMINATION; ELECTRICAL TESTING; HERMETICITY TESTING; INTERNAL VISUAL EXAMINATION; AND INTERNAL ELECTRICAL TESTING. DEVICE FAILURE WAS DUE TO CORROSION OF MATERIAL ON ONE OF RESISTORS BROUGHT ABOUT BY INTRUSION OF SMALL AMOUNTS OF MOISTURE INTO DEVICE. PLEASE REFER TO DEVICE FAILURE ANALYSIS REPORT. VISUAL EXAMINATION - NO DAMAGE WAS APPARENT. SILASTIC COATING WAS INTACT. BRIGHT LIGHT EXAMINATION - NOT PERFORMED SINCE X-RAY INSPECTION WAS PERFORMED. X-RAY EXAMINATION - X-RAY INSPECTION DID NOT REVEAL ANY LOOSE COMPONENTS OR CRACKS IN THE SUBSTRATE. ELECTRICAL TESTING - PCIT TESTING CONFIRMED THAT LINK WITH ICS COULD NOT BE ESTABLISHED. CASE HERMETICITY TESTING (LEAK TESTING) - FINE LEAK TESTING WAS PERFORMED ON THIS DEVICE. LEAK RATE WAS MEASURED AT 1.72X 10-8 CC-ATM./SECOND. THIS IS HIGHER LEAK RATE THAN 1.0 X 10-9 CC-ATM./SECOND REQUIREMENT. SOURCE OF THIS LEAK COULD NOT BE DETERMINED. CASE REMOVAL - THE CASE WAS REMOVED FOR INTERNAL VISUAL EXAMINATION AND TROUBLESHOOTING. INTERNAL VISUAL EXAMINTION - INTERNAL VISUAL INSPECTION REVEALED THAT RESISTOR (R4A) EXHIBITED CORROSION THAT CAUSED SHIFT IN ITS RESISTANCE VALUE. THIS RESISTOR IS ONE OF TWO RESISTORS IN DIVIDER NETWORK LOCATED IN FRONTY END OF DETECTION CIRUCITRY. SMALL CHANGES IN THIS RESISTOR'S VAULE WOULD CAUSE DEVICE NOT TO BE ABLE TO DETECT INCOMING TELEMETRY SIGNAL. INTERNAL ELECTRICAL TESTING - INTERNL ELECRICAL TESTING CONFIRMED THAT LINK COULD NOT BE ESTABLISHED BETWEEN EXTERNAL EQUIPMENT AND IMPLANT. CONCLUSION - CAUSE OF THIS DEVICE FAILURE WAS CORROSION OF RESISTOR MATERIAL ON R4A. CORROSION OF INTERNAL RESISTOR MATERIAL WAS DUE TO INTRUSION OF SMALL AMOUNTS OF MOISTURE INTO DEVICE. MOISTURE WAS ADMITTED INTO DEVICE VIA SMALL LEAK DETECTED DURING THIS ANALYSIS. WHEN EXAMINED DURING EXTERNAL VISUAL EXAMINATION, CASE, CASE TO CASE BAND INTERFACE AND HEADER AND PINS WERE ALL UNDAMAGED AND INTACT. DUE TO SMALL MAGNITUDE OF LEAK DETECTED, IT WAS NOT POSSIBLE TO LOCATE THE SITE OF LEAK. MFG RECORDS SHOW THAT THIS DEVICE MET HERMETICITY REQUIREMENTS WHEN IT WAS LAST TESTED. FOR THESE REASONS AND FINDINGS, CAUSE OF LEAK WILL REMAIN INCONCLUSIVE.

    Description of Event or Problem · 1

    A SIX YEAR-OLD GIRL WAS ORIGINALLY IMPLANTED ON JUNE 21, 1995. HER IMPLANT SYSTEM FUNCTIONED NORMALLY AND HER PARENTS HAVE INDICATED THAT THE CLARION HAS BEEN HELPFUL TO THEIR CHILD. WHEN PT WAS LAST SEEN AT THE IMPLANT CTR FOR A ROUTINE DEVICE EVALUATION IT WAS NOTED THAT SHE WAS NOT HEARING AS WELL AS SHE HAD AT THE PREVIOUS FITTING SESSION. TESTING OF THE DEVICE'S TELEMETRY SYSTEM DID NOT REVEAL ANY MALFUNCTIONS. WHEN THE CHILD WENT TO BED ON FEBRUARY 28, 1998, HER SYSTEM WAS FUNCTIONAL. UPON AWAKING THE NEXT MORNING HOWEVER, LINK COULD NOT BE ESTABLISHED BETWEEN THE EXTERNAL AND INTERNAL COMPONENTS. HER PARENTS TOOK HER TO THE IMPLANT CTR ON MARCH 11, 1998. TESTING CONDUCTED AT THAT TIME CONFIRMED THE IMPLANT WAS NO LONGER FUNCTIONING. REVISION SURGERY TOOK PLACE ON MARCH 18, 1998 AND 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-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR