BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 128136 · Received October 20, 1997

    Report

    Report Number
    2029203-1997-00021
    Event Type
    Other
    Date Received
    October 20, 1997
    Date of Event
    September 20, 1997
    Report Date
    September 23, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CORPORTATION BELIEVES THAT DISCLOSURE OF THE INFO REGARDING DEVICE EVALUATION COULD SUBSTANTIALLY HARM ITS COMPETITIVE POSITION. ADVANCED BIONICS CORPORATION SUBMITS THIS INFO IN CONFIDENCE EXPECTING THAT THE FDA WILL WITHHOLD IT UNDER EXEMPTION 4 OF THE FREEDOM OF INFO ACT. WE BELIEVE THAT ANY DISCLOSURE OF THE INFO BY A FEDERAL EMPLOYEE COULD CONSTITUTE A VIOLATION OF THE CRIMINAL LAW (18 U.S.C. SECTION 1905). DEVICE EVALUATION CONSISTED OF THE FOLLOWING: A REVIEW OF THE DEVICE HISTORY RECORD (DHR), VISUAL EXAMINATION AND X-RAY EXAMINATION. THE CASE WAS FOUND TO BE CRACKED. THE CRACKED CASE ALLOWED THE INTRUSION OF FLUIDS INTO THE ICS CAVITY RESULTING IN ELECTRICAL FAILURE. REFER TO ATTACHED DEVICE FAILURE ANALYSIS REPORT. THE FAILURE OF THIS ICS IS ATTRIBUTED TO THE CRACKED CASE AND LOSS OF HERMETIC SEAL. THE CRACKED CASE WAS INDUCED BY THE IMPACT THAT OCCURRED WHEN THE BROTHER DROPPED THE PT. THE CRACKED CASE ALLOWED THE INTRUSION OF FLUIDS INTO THE ICS CAVITY RESULTING IN ELECTRICAL FAILURE.

    Description of Event or Problem · 1

    ON SEMPTEMBER 20, 1997 A 3 1/2 YR-OLD BOY, WAS BEING HELD BY HIS BROTHER WHEN HE WAS DROPPED. PT FELL ONTO A LINOLEUM FLOOR, HITTING HIS HEAD DIRECTLY AT THE IMPLANT SITE. HIS IMPLANT SYS IMMEDIATELY CEASED FUNCTIONING. PARENTS TOOK HIM TO THE IMPLANT CENTER ON SEPTEMBER 23, 1997 FOR A DEVICE EVAL. WHILE AT THE CENTER, THE AUDIOLOGIST ATTEMPTED TO ESTABLISH LINK USING DIFFERENT SPEECH PROCESSORS, HEADPIECES AND CABLES. ALL ATTEMPTS WERE UNSUCCESSFUL. "NO LINK" WAS ALSO OBSERVED DURING TESTING WITH THE PORTABLE COCHLEAR IMPLANT TESTER (PCIT). THE AUDIOLOGIST THEN CONTACTED ADVANCED BIONICS AND AFTER DISCUSSING THE SITUATION, EXPLANTATION/REIMPLANTATION WAS RECOMMENDED. REVISION SURGERY WAS SCHEDULED FOR OCTOBER 6, 1997.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR