BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2850052 · Received November 26, 2012

    Report

    Report Number
    3006556115-2012-00534
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT'S ELECTRODE ARRAY HAS MIGRATED INTO THE TYMPANIC MEMBRANE. THE PATIENT'S DEVICE WAS EXPLANTED AND TYMPANIC MEMBRANE WAS REPAIRED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention