BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2023797 · Received March 10, 2011

    Report

    Report Number
    3006556115-2011-00092
    Event Type
    Injury
    Date Received
    March 10, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S DEVICE WILL BE EXPLANTED. THE PT WILL BE REIMPLANTED WITH ANOTHER COCHLEAR DEVICE. ADVANCED BIONICS IS CURRENTLY GATHERING MORE INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention