BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 140636 · Received December 22, 1997

    Report

    Report Number
    2029203-1997-00026
    Event Type
    Other
    Date Received
    December 22, 1997
    Date of Event
    November 25, 1997
    Report Date
    November 25, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIDENTIALITY: ADVANCED BIONICS BELIEVES THAT DISCLOSURE OF INFFO REGARDING DEVICE EVAL COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSTION. ADVANCED BIONICS SUBMITS THIS INFO IN CONFIDENCE EXPECTINGG FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF FREEDOM ON INFO ACT. WE BELIEVE THAT ANY DISCLOSURE OF INFO BY FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF CRIMINAL LAW (18 U.S.C. SECTION 1905) SECTION H.6 - DEVICE EVALUATION CONSISTED OF: REVIEW OF THE DEVICE HISTORY RECORD (DHR); VISUAL EXAMINATION, X-RAY EXAMINATION; ELECTRICAL TESTING; HERMETICITY TESTING; INTERNAL VISUAL EXAMINATION AND INTERNAL ELECTRICAL TESTING. SECTION H.6 - PLEASE REFER TO ATTACHED DEVICE FAILURE ANALYSIS REPORT. BACKGROUND: PT WAS ORGINALLY IMPLANTED ON 10/16/1997. SHE RETURNED TO IMPLANT CENTER ON 11/25/1997, FOR HER INITIAL FITTING SESSION. ACCORDING TO INFO RECEIVED FROM IMPLANT CENTER'S AUDIOLOGIST, RF LINK WAS LOST WITH INTERNAL DEVICE APPROX 30 MINUTES INTO SESSION. AUDIOLOGIST CONTACTED ADVANCED BIONICS AND SPOKE TO IN-HOUSE CLINICAL SPECIALIST. SEVERAL ATTEMPTS AT RESOLVING PROBLEM WERE MADE, INCLUDING CHANGE-OUT OF EXTERNAL EQUIPMENT, TESTING WITH PORTABLE COCHLEAR IMPLANT TESTER AND FITTING SOFTWARE, TO NO AVAIL. FAMILY STATED THAT THEY WERE UNAWARE OF ANY FALLS OF IMPACT TO IMPLANT SITE. REVISION SURGERY TOOK PLACE ON 12/4/1997. MFG START: 5/16/1997. MFG END: 7/2/1997. DURING THIS DEVICE'S MFG PROCESS, IT FAILED FIRST LEAK TEST ON 6/5/1997 AFTER WELD WITH LEAK OF 4.2X 10-7 CC-ATM/SEC. THIS DEVICE WAS RE-TESTED ON THE SAME DATE AND FOUND TO BE ACCEPTABLE. PRACTICE OF REPEATING LEAK TEST WHEN FINE LEAK FAILURE OCCURS HAS BEEN USED IN DETERMINING WHETHER IT RESULTED FROM ENTRAPPED HELIUM OUT-GASSING FROM SURFACE CONTAMINATION OR FROM TEST SET UP PROBLEM. ALLOWING DEVICE TO STAND FOR SHORT PERIOD OF TIME ALLOWS ANY TRAPPED HELIUM TO ESCAPE ENABLING TRUE LEAK RATE TO BE MEASURED. IN THIS CASE SECOND MEASUREMENT THAT SAME DAY SHOWED THIS DEVICE TO BE ACCEPTABLE. THIS DEVICE PASSED FINAL LEAK TEST ON 6/18/1997. THIS OCCURRENCE IS BELIEVED TO BE UNRELATED TO FAILURE MECHANISM OF THIS DEVICE. NO OTHER DISCREPANCIES WERE RECORDED. VIAUAL EXAMINATION: SILICONE COATING ON CASE OF THIS DEVICE WAS INTACT AND ADHERED WELL TO CASE. SMALL CLOSED CHIP OUT WAS NOTED ON LEFT FRONT SIDE OF ICS AT CASE TO CASE BAND INTERFACE. CLOSED CHIP OUT IS CHIP OUT WHERE SEPARTED CERAMIC IS STILL PRESENT AT LOCATION OF DAMAGE. THIS CHIP OUT WAS APPROX 0.006 INCHES WIDE BY 0.0055 INCHES LONG. ELECTRODE WAS CUT IN HALF AND SPIRAL WAS MISSING. ELECTRODE FANTAIL WAS IN GOOD CONDITION. BRIGHT LIGHT EXAMINATION: BRIGHT LIGHT EXAMINATION WAS NOT PERFORMED SINCE X-RAY EXAMINATION WAS PERFORMED. X-RAY EXAMINATION: X-RAY EXAMINATION REVEALED NO ANOMALIES OR INTERNAL MECHANICAL DAMAGE. ELECTRICAL TESTING: TESTING WITH PCIT VERIFIED THAT RF LINK COULD NOT BE OBTAINED. CASE HERMETICITY TESTING (LEAK TESTING): THIS DEVICE FAILED GROSS LEAK TEST. STEADY STREAM OF BUBBLES WAS DETECTED ALONG CASE TO CASE BAND INTERFACE ADJACENT TO BUT NOT INCLUDING CHIP OUT DISCOVERED DURING EXTERNAL VISUAL EXAMINATION. CASE REMOVAL: CASE REMOVAL WAS PERFORMED BY INDUCING SEPARATION OF CASE AND CASE BAND. SEPARATED PORTION OF CLOSED CERAMIC CHIP OUT REMAINED WITH CASE BAND. INTERNAL VISUAL EXAMINATION: DAMAGE OF RESISTORS R2A AND R28 WAS NOTED. DAMAGE NOTED IN EACH RESISTOR WAS DUE TO CORROSION. CORROSION OF THESE DEVICES WAS CAUSED BY PRESENCE OF MOISTURE INSIDE DEVICE. INTERNAL ELECTRICAL TESTING: RF LOCK COULD NOT BE ESTABLISHED. CONCLUSION: THE CLOSED CHIP OUT DISCOVERED DURING FAILURE ANALYSIS INVESTIGATION WAS NOT RECORDED DURING MFR OF THIS DEVICE. IT IS CLEARLY VISIBLE AND IS NOT CONSIDERED ACCEPTABLE PER ADVANCED BIONICS VISUAL INSPECTION CRITERIA. IF THIS CHIP OUT WAS PRESENT DURING MFR OF THIS DEVICE, IT IS HIGHLY UNLIKELY THAT THIS CHIP OUT WOULD HAVE ESCAPED THREE SUBSEQUENT LEVELS OF VISUAL INSPECTIONS WITHOUT NOTICE. EXACT SOURCE OF CHIP OUT OBSERVED DURING FAILURE ANALYSIS IS NOT KNOWN. HOWEVER, AFTER CHIP OUT WAS INTRODUCED ON CASE, STRESSES WERE INDUCED IN ADJACENT AREAS OF CASE BAND BRAZE. THESE STRESSES WEAKENED CASE TO CASE BAND BRAZE. ANY STRESSES, MECHANICAL OR THERMAL, ENCOUNTERED AFTER CHIP OUT WAS INTRODUCED ON CASE COULD RESULT IN GROSS LEAK OBSERVED DURING FAILURE ANALYSIS INVESTIGATION. CORRECTIVE ACTION: CONTINUOUS PRODUCT IMPROVEMENT EFFORTS HAVE RESULTED IN DEVELOPMENT OF STRONGER CASES THROUGH DESIGN AND PROCESS PARAMETER OPTIMIZATION. MORE THAN 50% INCREASE IN AVERAGE STATIC STRENGTH HAVE BEEN ACHIEVED TO DATE, WHICH HAVE LED TO SIGNIFICANT REDUCTIONS OF CASE FAILURES.

    Description of Event or Problem · 1

    A 7 1/2 YR-OLD GIRL, WAS ORIGINALLY IMPLANTED ON OCTOBER 16, 1997. SHE RETURNED TO THE IMPLANT CTR ON NOVEMBER 25, 1997 FOR HER INITIAL DEVICE FITTING SESSION. ACCORDING TO INFO REC'D FROM THE CTR'S AUDIOLOGIST, WHILE CHECKING THE T LEVELS ON ALL 8 CHANNELS (APPROX 30 MINS INTO THE SESSION), RF LINK WAS LOST WITH THE INTERNAL DEVICE. THE AUDIOLOGIST CONTACTED ADVANCED BIONICS AND SPOKE TO THE IN-HOUSE CLINICAL SPECIALIST. SEVERAL ATTEMPTS AT RESOLVING THE PROBLEM WERE MADE, INCLUDING A CHANGE-OUT OF THE EXTERNAL EQUIPMENT, TESTING WITH THE PORTABLE COCHLEAR IMPLANT TESTER AND FITTING SOFTWARE, BUT TO NO AVAIL. EXPLANTATION/REIMPLANTATION TOOK PLACE ON DECEMBER 4, 1997. 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 7 YR