BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K¿ IMPLANT

    MDR report key: 6695283 · Received July 7, 2017

    Report

    Report Number
    3006556115-2017-00360
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 16, 2017
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED THE EXTERNAL VISUAL INSPECTION. THE PHOTOGRAPHIC IMAGING INSPECTION REVEALED A BROKEN ELECTRODE NEAR THE ARRAY. THIS IS BELIEVED TO HAVE OCCURRED DURING DEVICE REMOVAL. SYSTEM LOCK WAS VERIFIED. THE DEVICE PASSED THE ELECTRICAL TESTS PERFORMED. THE DEVICE FAILED THE RESIDUAL GAS ANALYSIS TEST. THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. THE DEVICE PASSED THE ELECTRICAL TESTS PERFORMED. HOWEVER, THIS DEVICE HAD MOISTURE THAT EXCEEDED THE RESIDUAL GAS ANALYSIS TEST LIMIT. THE SOURCE OF THE PROBLEM AS A FEEDTHRU HERMETICITY ISSUE FROM ONE FEEDTHRU VENDOR. A CAPA WAS IMPLEMENTED. FEEDTHRU ASSEMBLIES FROM THIS VENDOR ARE NO LONGER USED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. DUE DILIGENCE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING RECIPIENT STATUS WERE UNSUCCESSFUL. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE RECIPIENT REPORTEDLY EXPERIENCED A SKIN FLAP INFECTION AND DEVICE EXTRUSION. THE RECIPIENT'S INTERNAL DEVICE WAS REMOVED AT HOME BY THE RECIPIENT'S CAREGIVER. ON (B)(6) 2017, THE RECIPIENT WAS PRESCRIBED OMNICEF FOR 10 DAYS. THE RECIPIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473997 HIRES 90K¿ IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention