BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1902476 · Received November 11, 2010

    Report

    Report Number
    3006556115-2010-00564
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY WAS ADMITTED TO THE HOSPITAL DUE TO FLUID OBSERVED AT THE IMPLANT SITE. THE PATIENT REPORTEDLY HAD HEADACHE AND PAIN AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE UNKNOWN). THE PATIENT CONTINUES TO BE MONITORED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention