BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K¿ IMPLANT

    MDR report key: 6064932 · Received October 28, 2016

    Report

    Report Number
    3006556115-2016-00454
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 8, 2016
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SEVERED PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. IN ADDITION, A SMALL DENT WAS OBSERVED ON THE TOP COVER. THE PHOTOGRAPHIC IMAGING INSPECTION REVEALED SEVERAL BROKEN ELECTRODE WIRES NEAR ONE OF THE FEEDTHRU PINS. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION PREVENTED SOME OF THE ELECTRICAL TESTS FROM BEING PERFORMED. THE DEVICE PASSED ALL OF THE ELECTRICAL TESTS PERFORMED. THIS IS AN INTERIM REPORT.

    Additional Manufacturer Narrative · 1

    THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SEVERED PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. IN ADDITION, A SMALL DENT WAS OBSERVED ON THE TOP COVER. THE PHOTOGRAPHIC IMAGING INSPECTION REVEALED SEVERAL BROKEN ELECTRODE WIRES NEAR ONE OF THE FEEDTHRU PINS. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION PREVENTED SOME OF THE ELECTRICAL TESTS FROM BEING PERFORMED. THE DEVICE PASSED ALL OF THE ELECTRICAL TESTS PERFORMED. THE RESIDUAL GAS ANALYSIS RESULT REVEALED NITROGEN ABOVE THE TEST LIMIT. THE DISSECTION AND SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE ELECTRODE REVEALED EVIDENCE OF TENSILE BREAKS. THESE BREAKS CORRESPOND TO SEVERAL OF THE ELECTRODE CHANNELS. THE PHOTOGRAPHIC IMAGING INSPECTION AND ELECTRODE DISSECTION REVEALED BROKEN ELECTRODE WIRES BETWEEN SOME OF THE FEEDTHRU PINS. THESE BREAKS CORRESPOND TO THE ELECTRODE CHANNELS REPORTED OPEN. A CAPA WAS IMPLEMENTED. IN ADDITION, THIS DEVICE HAD NITROGEN THAT EXCEEDED THE LIMIT. BASED ON AN ASSESSMENT OF THE DYE PENETRANT TEST DATA, IT IS DETERMINED THAT THIS DEVICE WAS NON-HERMETIC, AND THAT THE ROOT CAUSE OF THE EXCESSIVE NITROGEN WAS A LEAK THROUGH THE FEEDTHRU SEALS. DUE TO THE PRESENCE OF MOISTURE GETTER, NO SIGNS OF MOISTURE WERE OBSERVED. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EXPLANT DATE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Description of Event or Problem · 1

    THE RECIPIENT IS REPORTEDLY EXPERIENCING MULTIPLE OPEN ELECTRODES. DEVICE REVISION SURGERY IS BEING SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714908 HIRES 90K¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR