BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3152524 · Received June 5, 2013

    Report

    Report Number
    3006556115-2013-00233
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED FACIAL NERVE STIMULATION. PROGRAMMING ADJUSTMENTS WERE MADE AND EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248955 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention