BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3012283 · Received March 12, 2013

    Report

    Report Number
    3006556115-2013-00092
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING POOR PERFORMANCE AND LACK OF PROGRESS. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104528 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention