BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 634230 · Received September 12, 2005

    Report

    Report Number
    2029203-2005-00360
    Event Type
    Injury
    Date Received
    September 12, 2005
    Date of Event
    August 19, 2005
    Report Date
    September 12, 2005
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS OBSERVED THAT THE PT WAS NOT RESPONDING CONSISTENTLY TO SOUND. IN 08/2005, THE PT WAS SEEN BY A CO REPRESENTATIVE FOR DEVICE EVALUATION. THE RECOMMENDATION FOR A CT SCAN WAS MADE. A WEEK LATER, THE CO WAS NOTIFIED THAT THE SURGEON SCHEDULED SURGERY TO REINSERT THE ELECTRODE ARRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention