BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 112358 · Received August 7, 1997

    Report

    Report Number
    2029203-1997-00015
    Event Type
    Other
    Date Received
    August 7, 1997
    Date of Event
    February 22, 1997
    Report Date
    July 7, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONCIS BELIEVES THAT DISCLOSURE OF INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS CORP SUBMITS THIS INFO IN CONFIDENCE EXPECTING THAT FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF FREEDOM OF INFO ACT. CO BELIEVES THAT ANY DISCLOSURE OF INFO BY FEDERAL EMPLOYEE COULD CONSTUTUTE VIOLATION OF CRIMINAL LAW (18 U.S.C. SECTION 1905). DEVICE EVALUATION CONSISTED OF FOLLOWING: REVIEW OF DEVICE HISTORY RECORD (DHR), VISUAL EXAMINATION, AND ELECTRICAL TESTING. THERE WAS NO DEVICE FAILURE. ELECTRICAL TESTING CONDUCTED ON DEVICE UPON ITS RETURN CONFIRMED FUNCTIONALITY. IT IS BELIEVED THAT REPORTED PAIN AND ELECTRICAL SHOCK EXPERIENCED BY PT WERE MOST LIKELY DUE TO ELECTRODE'S CLOSE PROXIMITY TO PT'S FACIAL NERVE RESULTING FROM SURGICAL TECHNIQUE EMPLOYED AT IMPLANTATION. RESULTS OF TESTING FAILED TO IDENTIFY REASON FOR PAIN AND ELECTRICAL SHOCK SENSATIONS REPORTED BY PT. ONLY EXPLNATATION FOR SENSATIONS REPORTED BY PT RELATE TO SURGERY ITSELF. AS REPORTED BY SURGEON, DUE TO UNUSUAL ANATOMICAL CIRCUMSTANCE (OSSIFICATION OF LOWER COCHLEA) THAT PRECLUDED ROUTINE ACCESS THROUGH COCHLEAR WINDOW, SURGEON ELECTED TO PERFORM TRANS-CANAL IMPLANTATION. THIS MAY HAVE RESULTED IN ELECTRODE LYING CLOSE TO FACIAL NERVE. EITHER PHYSICAL CONTACT WITH NERVE OR ELECTRICAL STIMULATION OF THAT NERVE BY ELECTRODE COULD HAVE POSSIBLY CAUSED PAIN SENSATION PT REPORTED. THIS IS FIRST INCIDENT OF THIS KIND REPORTED TO DATE. NO CORRECTIVE ACTION IS NECESSARY SINCE REPORTED INCIDENT WAS MOST LIKELY DUE TO ELECTRODE'S CLOSE PROXIMITY TO PT'S FACIAL NERVE. THIS CLOSE PROXIMITY WITH FACIAL NERVE WAS RESULT OF TRANS-CANAL IMPLANTATION STRATEGY USED BY SURGEON PROMPTED BY UNUSUAL ANATOMICAL FEATURES DISCOVERED DURING IMPLANT SURGERY. EXTERNAL VISUAL EXAMINATION REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    F382 WAS ORIGINALLY IMPLANTED ON NOV. 14, 1996. INITIAL DEVICE FITTING TOOK PLACE ON DEC.16, 1996. ALTHOUGH HER IMPLANT SYSTEM FUNCTIONED PROPERLY AND SHE OBTAINED IMMEDIATE AUDITORY PERCEPTION, IT IS REPORTED THAT F382 COMPLAINED OF SLIGHT PAIN AROUND THE IMPLANT SITE WHEN STIMULATION WAS INITIALLY BEGUN. SEVERAL ROUTINE DEVICE EVALUATIONS WERE MADE OVER THE NEXT SEVERAL MONTHS. ON EACH OCCASION, ALTHOUGH THE SYSTEM CONTINUED TO FUNCTION NORMALLY AND ELECTRODE IMPEDANCES WERE WITHIN THE NORMAL RANGE, F382 WOULD COMPLAIN OF PAIN AT THE IMPLANT SITE. ONE OF THE ORIGINAL IMPLANTING SURGEONS WAS CONSULTED TO INFORM HIM OF THE PT'S BEHAVIORAL RESPONSES. ACCORDING TO THE SURGEON, F382 HAD AN UNUSUAL ANATOMIC MAKEUP THAT PRECLUDED USING THE NORMAL TRANSMASTOID-FACIAL RECESS APPROACH TO THE ROUND WINDOW. BECAUSE OF THIS ANATOMIC VARIATION, A TRANSCANAL APPROACH WAS USED. IT WAS FELT THAT THE COMPLAINT OF SENSITIVITY MAY BE THE RESULT OF THIS PARTICULAR SURGICAL APPROACH. F382 WAS PLACED ON MEDICATION AND MONITORED FOR THE NEXT SEVERAL MONTHS. BECAUSE THERE HAD BEEN ON MARKED IMPROVEMENT IN THE PT'S CONDITION, IT WAS DECIDED TO EXPLANT HER 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 33 YR