BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 80904 · Received March 28, 1997

    Report

    Report Number
    2029203-1997-00004
    Event Type
    Other
    Date Received
    March 28, 1997
    Date of Event
    February 1, 1997
    Report Date
    February 21, 1997
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H.6 - DEVICE EVAL CONSISTED OF FOLLOWING: REVIEW OF DEVICE HISTORY RECORD (DHR), VISUAL EXAMINATION, ELECTRICAL TESTING, AND X-RAY EXAMINATION. SECTION H.6 MALFUNCTION WAS IDENTIFIED AS FAILURE IN ELECTRODE WIRES. CAUSE OF FAILURE HAD BEEN TRACED TO SEVERAL ANOMALIES CONCERNING ORIGINAL IMPLANT SURGICAL TECHNIQUE. PT EXPERIENCE PRIOR TO FAILURE: IMPEDANCES MEASURED ON 2/21/1997 ARE AS FOLLOWS: 1M: 19.2K, 1L: 62.5K, 2M: 22.1K; 2L: 299K; 3M: 150K; 3L: 237K; 4M: 999K; 4L: 349K; 5M: 19.2K; 5L: 57.5K; 6M: 622; 6L: 785K; 7M: 220K; 7L: 422K; 8: 480K; AND 8L: 844K. DEVICE WAS REMOVED SIXTEEN MONTHS POST IMPLANT. REVIEW OF DEVICE HISTORY RECORD (DHR): MFG START: 8/2/1995. MFG END: 9/21/1995. NOTHING UNUSUAL WAS NOTED IN DHR. THERE WAS NO REWORK PERFORMED DURING MFG. VISUAL EXAMINATION: VISUAL EXAMINATION REVEALED EVIDENCE OF DAMAGE TO ELECTRODE WIRES WITHIN FANTAIL REGION. FURTHER EXAMINATION UNDER HIGHER MAGNIFICATION REVEALED EVIDENCE OF WIRE BREAKAGE. SPIRAL PORTION OF ELECTRODE LEAD, INCLUDING CONTACT BALLS, WAS CUT OFF BY SURGEON AT TIME OF EXPLANTATION AND WAS NOT RETURNED WITH DEVICE. ELECTRICAL TESTING: DEVICE WAS TESTED AND IT WAS CONFIRMED THAT ELECTRONIC CIRCUITRY PERFORMED CORRECTLY. THERE WAS COMMUNICATION ("LINK") BETWEEN ICS AND HEADPIECE. IN ORDER TO MEASURE IMPEDANCES, ELECTRODE CONTACT BALLS WERE RE-CONSTRUCTED (ELECTRODE LEAD WAS CUT OFF AT SPIRAL REGION). IMPEDANCE READINGS ARE AS FOLLOWS: 1M: 2.7K 1L: 2.0K; 2M: 1.8K 2L: 99.9K; 3M: 81.5K; 3L: 120K; 4M: 999K; 4L: 834K; 5M: 999K; 5L: 999K; 6M: 999K; 6L: 999K; 7M: 338K; 7L: 455K; 8M: 999K AND 8L: 999K. X-RAY EXAMINATION: X-RAY EXAMINATION OF FANTAIL AREA WAS PERFORMED SO ALL WIRES COULD BE OBSERVED MORE CLEARLY. X-RAY REVEALED EVIDENCE OF WIRE BREAKAGE IN FANTAIL REGION NEAR JUNCTION WHERE WIRES ENTER DACRON TUBING. BREAKS CONFIRMED ABOVE IMPEDANCE MEASUREMENTS. OBSERVATIONS MADE DURING REVISION SURGERY INDICATE THAT ORIGINAL IMPLANT WAS PERFORMED CORRECTLY WITH ONE EXCEPTION. SUTURES USED TO FIX THIS DEVICE IN BONY RECESS WERE DISSOLVING TYPE. THIS MAY HAVE CONTRIBUTED TO FAILURE. EXAMINATION OF X-RAY RADIOGRAPH MADE OF FANTAIL REGION OF THIS DEVICE REVEALED THAT WIRE BREAKS ARE CONCENTRATED IN FANTAIL AREA VERY CLOSE TO WHERE WIRES EXIT DACRON SLEEVING TO ENTER FANTAIL REGION. WIRES NO NOT APPEAR KINKED WHICH WOULD INDICATE THAT STRETCH AND RECOILD PHENOMENON HAD NOT BEEN EXPERIENCED. BROKEN WIRE ENDS ARE DISPLACED FROM ONE ANOTHER IN OVERLAPPING FASHION. WIRES APPEAR TO HAVE SUSTAINED CLEAN BREAKS WHICH INDICATES THAT FATIGUE MAY HAVE CONTRIBUTED TO THEIR FAILURES. WIRE END DISPLACEMENT ALSO INDICATES THAT FANTAIL HAD UNDERGONE TENSION CYCLING IN AREA OF BREAKS, WHICH INTRODUCED THAT DISPLACEMENT. OBSERVED WIRE FAILURES ARE PROBABLE RESULT OF LACK OF STABILIZATION OF DEVICE AT IMPLANT SITE. USE OF DISSOLVING SUTURES ALLOWED DEVICE TO BECOME MOBILE IN DEVICE RECESS CREATED DURING SURGERY.

    Description of Event or Problem · 1

    ACCORDING TO INFO RECEIVED FROM THE IMPLANT CENTER, PT WAS ORIGINALLY IMPLANTED WITH HIS IMPLANT ON 11/95. THERE WERE NO REPORTED PROBLEMS WITH HIS PERFORMACE. SOMETIME DURING THE FIRST WEEK OF 2/97, DEVICE'S PERFORMACE BEGAN TO DETERIORATE. ON 2/21/97, HE WAS SEEN AT THE CENTER WHERE IT WAS NOTED THAT SOME OF THE ELECTRODES WERE EXHIBITING HIGH IMPEDANCE READINGS. DEVICE WAS REPROGRAMMED BUT HE WAS UNABLE TO OBTAIN MAXIMUM BENEFIT. PT WAS THEN SCHEDULED FOR EXPLANT/REIMPLANTION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION Implant COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other