BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARION

    MDR report key: 140808 · Received December 22, 1997

    Report

    Report Number
    2029203-1997-00024
    Event Type
    Other
    Date Received
    December 22, 1997
    Date of Event
    September 17, 1997
    Report Date
    December 4, 1997
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION CONSISTED OF THE FOLLOWING: A REVIEW OF THE DEVICE HISTORY RECORD (DHR), VISUAL EXAMINATION, AND INTERNAL VISUAL EXAMINATION. THE CASE AND SUBSTRATE WERE FOUND TO BE CRACKED. THIS DAMAGE RESULTED IN THE FAILURE OF THE ICS. PLEASE REFER TO THE DEVICE FAILURE ANALYSIS REPORT. REVIEW OF DEVICE HISTORY RECORD (DHR): TWO COMPONENTS WERE REPLACED DURING THE MFG CYCLE OF THIS DEVICE. BOTH COMPONENTS (RESISTORS, R31 AND R32) WERE REPLACED. HYBRID ALSO HAD ONE NON-CONDUCTIVE EPOXY FILLET REPAIRED. VISUAL EXAMINATION: ICS CASE WAS CRACKED ON BOTH SIDES. THE SUBSTRATE WAS ALSO DAMAGED. ELECTRODE WAS INTACT AND ALL ELECTRODE BALLS WERE IN PLACE. INTERNAL VISUAL EXAMINATION: SUBSTRATE IS CRACKED IN SEVERAL PLACES. CONCLUSION: THE FAILURE OF THIS ICS IS ATTRIBUTED TO THE BROKEN CASE AND SUBSTRATE. THIS DEVICE DAMAGE WAS THE RESULT OF THE REPORTED FALL. CORRECTIVE ACTION: ADVANCED BIONICS CORPORATION IS CONTINUING TO INVESTIGATE WAYS OF INCREASING THE STRENGTH OF THE ICS CASES.

    Description of Event or Problem · 1

    A 3 YR-OLD GIRL, WAS ORIGINALLY IMPLANTED ON JANUARY 23, 1997. ON SEPTEMBER 17, 1997, SHE FELL DOWN. PT WAS UNABLE TO BREAK HER FALL, BECAUSE ANOTHER CHILD'S ARMS WERE AROUND HER. HEMATOMA AND SWELLING WERE OBSERVED AROUND THE IMPLANT SITE. WHEN PT WAS SEEN AT THE CTR ON OCTOBER 14, 1997, ALTHOUGH THE SWELLING HAD REDUCED SIGNIFICANTLY, HER IMPLANT WAS NO LONGER FUNCTIONING. ATTEMPTS AT THE IMPLANT CTR TO RESOLVE THE PROBLEM WERE UNSUCCESSFUL. REVISION SURGERY OCCURRED ON OCTOBER 20, 1997.

    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 MO