BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 170628 · Received May 28, 1998

    Report

    Report Number
    2029203-1998-00012
    Event Type
    Other
    Date Received
    May 28, 1998
    Date of Event
    April 1, 1997
    Report Date
    May 4, 1998
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCE BIONICS BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS SUBMITS THIS INFO IN CONFIDENCE EXPECTING THE FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF THE FREEDOM OF INFO ACT. CO BELIEVES THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSITITUTE A VIOLATION OF THE CRIMINAL LAW (18 U.S.C. SECTION 1905). SECTION H.6 - DEVICE EVALUATION CONSISTED OF: A REVIEW OF THE DEVICE HISTORY RECORED, VISUAL EXAMINATION, X-RAY EXAMINATION, ELECTRICAL TESTING AND HERMETICITY TESTING. SECTION H.6. - BACKGROUND: THE PT WAS ORIGINALLY IMPLANTED ON AUGUST 16, 1996. THE PT WENT TO THE CENTER FOR DEVICE EVALUATION ON MAY 4, 1998 BECAUSE HE WAS NO LONGER ABLE TO HEAR. WHILE AT THE CENTER, THE PT INDICATED THAT HE HAD HIT HIS HEAD DURING THE LAST WEEK IN APRIL 1997. NEITHER THE EXACT DATE OF THE IMPACT NOR THE CIRCUMSTANCES SURROUNDING THAT EVENT ARE KNOWN AT THIS TIME. THE PT STATED THAT ALTHOUGH THERE WAS SWELLING AROUND THE IMPLANT SITE, HIS IMPLANT CONTINUED TO FUNCTION NORMALLY OVER THE COURSE OF THE NEXT TWELVE MONTHS. IT APPEARS THAT DEVICE FUNCTIONALITY CEASED ON ABOUT MAY 4, 1998. TESTING CONDUCTED AT THE CENTER CONFIRMED THAT THE CLARION SYSTEM WAS NO LONGER FUNCTIONING. REVISION SURGERY TOOK PLACE ON MAY 11, 1998. REVIEW OF DEVICE HISTORY RECORD (DHR): MFG START: 05/03/1996. MFG END: 06/26/1996. NO REWORK RELATED TO THIS FAILURE WAS PERFORMED ON THIS DEVICE DURING THE MFG PROCESS. VISUAL EXAMINATION: THE DEVICE CASE WAS INTACT WITH NO CRACKS EVIDENT. THE ELECTRODE WAS ALSO INTACT AND THE ELECTRODE ARRAY WAS IN GOOD SHAPE. 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 THE RF LINK COULD NOT BE OBTAINED. CASE HERMETICITY TESTING (LEAK TESTING): THIS DEVICE FAILED GROSS LEAK TEST. A STEADY STREAM OF BUBBLES WAS DETECTED ALOND THE CASE TO CASE BAND INTERFACE ON THE FRONT SIDE OF THE DEVICE IN THE CENTER PART OF THE BRAZE AREA. CASE REMOVAL: CASE REMOVAL WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. INTERNAL VISUAL EXAMINATION: INTERNAL VISUAL EXAMINATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. INTERNAL ELECTRICAL TESTING: INTERNAL ELECTRICAL TESTING WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. CONCLUSION: THIS DEVICE FAILURE WAS CAUSED BY THE LEAK DETECTED AT THE CASE TO CASE BAND INTERFACE. THIS LEAK ALLOWED FLUIDS TO ENTER THE DEVICE THAT RESULTED IN THE CORROSION OF THE INTERNAL COMPONENTS. THE IMPACT MOST LIKELY CAUSED THE FINE LEAK THAT ALSO WEAKENED THE CASE BAND BRAZE. IT IS SUSPECTED THAT SUBSEQUENT HANDLING DURING THE EXPLANT SURGERY DEGRADED THE BOND FURTHER ESTABLISHING THE GROSS LEAK DETECTED DURING THIS INVESTIGATION. THIS WOULD ACCOUNT FOR THE ONE-YEAR TIME SPAN FROM THE DATE OF THE IMPACT TO THE DEVICE FAILURE. CORRECTIVE ACTION; CONTINUOUS PRODUCT IMPROVEMENT EFFORTS HAVE RESULTED IN THE DEVELOPMENT OF STRONGER CASES THROUGH DESIGN AND PROCESS PARAMETER OPTIMIZATION. MORE THAN 50% INCREASE IN AVERAGE STATIC STRENGTH HAS BEEN ACHIEVED TO DATE. THE INCREASE IN THE CASE STRENGTH ENHANCES THE IMPACT STRENGTH OF THE CASE BAND BRAZE SITE AS WELL. AS THE CASE BECOMES STRONGER AND STIFFER, THE AMOUNT OF DEFLECTION FOR A GIVEN IMPACT IS LOWERED DUE TO THE ADDED STRENGTH. THE OCCURRENCE OF THIS DEVICE'S FAILURE MODE HAS BEEN LOW, AND THIS ADDITION OF IMPACT STRENGTH WILL FURTHER REDUCE THE PROBABILITY OF THIS TYPE OF FAILURE.

    Description of Event or Problem · 1

    A 9 1/2 YEAR-OLD BOY WAS ORIGINALLY IMPLANTED ON 8/10/1998. PT WENT TO THE CENTER FOR DEVICE EVALUATION ON 5/4/1998 BECAUSE HE WAS NO LONGER ABLE TO HEAR. WHILE AT THE CENTER THE PT INDICATED THAT HE HAD HIT HIS HEAD DURING THE WEEK IN 4/1997. NEITHER THE EXACT DATE OF IMPACT NOR THE CIRCUMSTANCES SURROUNDING THE EVENT ARE KNOWN AT THIS TIME. PT STATED THAT ALTHOUGH THERE WAS SWELLING AROUND THE IMPLANT SITE, HIS IMPLANT CONTINUED TO FUNCTION NORMALLY OVER THE COURSE OF THE NEXT TWELVE MONTHS. IT APPEARS THAT DEVICE FUNCTIONALITY CEASED ON OR ABOUT 5/4/1998. TESTING CONDUCTED AT THE CENTER CONFIRMED THE CLARION SYSTEM WAS NO LONGER FUNCTIONING.

    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 8 YR