BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2151636 · Received June 30, 2011

    Report

    Report Number
    3006556115-2011-00330
    Event Type
    Injury
    Date Received
    June 30, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT DEVELOPED A STAPH INFECTION AT THE IMPLANT SITE. THE PATIENT'S TREATMENT IS ONGOING AND SHE IS ON HER THIRD COURSE OF ANTIBIOTICS (TYPE UNKNOWN). THE PATIENT IS ATTEMPTING TO KEEP THE EXTERNAL EQUIPMENT OFF THE AFFECTED AREA. THE PATIENT IS BEING 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 Required Intervention