BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 2892233 · Received December 27, 2012

    Report

    Report Number
    3006556115-2012-00595
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED FOR A TECHNOLOGY UPGRADE. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention