BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 4864905 · Received June 22, 2015

    Report

    Report Number
    3006556115-2015-00279
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    August 5, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTERNAL VISUAL INSPECTION REVEALED A SLICE ON THE ELECTRODE LEAD AND A DAMAGED BOTTOM COVER. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE PHOTOGRAPHIC IMAGING INSPECTION CONFIRMED SLICES ON THE ELECTRODE LEAD. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION PREVENTED SOME OF THE ELECTRICAL TESTS FROM BEING PERFORMED. THE DEVICE PASSED SEVERAL OF THE ELECTRICAL TESTS FROM BEING PERFORMED. THE DEVICE FAILED THE RESIDUAL GAS ANALYSIS TEST. THE INTERNAL VISUAL INSPECTION NOTED SILVER MIGRATION BETWEEN SOME ELECTRICAL COMPONENTS. THE SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE ARRAY IDENTIFIED DAMAGED PARYLENE ON ONE OF THE ELECTRODES NEAR A CONTACT PAD. THIS DEVICE HAD MOISTURE THAT EXCEEDED THE RESIDUAL GAS ANALYSIS TEST LIMIT. THE SOURCE OF THE PROBLEM WAS A FEEDTHRU HERMETICITY ISSUE FROM ONE FEEDTHRU VENDOR. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED. FEEDTHRU ASSEMBLIES FROM THIS VENDOR ARE NO LONGER USED. IN ADDITION, DAMAGE TO THE PARYLENE WIRE COATING WAS FOUND ON ONE OF THE ELECTRODES WHERE THE WIRE PASSED THE ADJACENT ELECTRODE CONTACT PAD. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THIS IS NOT BELIEVED TO BE RELATED TO THE RETURN REASON. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Description of Event or Problem · 1

    THE PATIENT IS REPORTED EXPERIENCING DELAYED ONSET OF SOUND. EXTERNAL EQUIPMENT IS EXCHANGED, WHICH TEMPORARILY RESOLVES THE ISSUE. DEVICE TESTING RESULTS WERE FOUND TO BE WITHIN NORMAL LIMITS. REVISION SURGERY WILL BE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403084 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention