BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3030348 · Received March 28, 2013

    Report

    Report Number
    3006556115-2013-00113
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S DEVICE WILL BE EXPLANTED FOR MEDICAL REASONS. THE SURGERY HAS BEEN SCHEDULED. THE COMPANY IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE NEW INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128370 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention