BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2850690 · Received November 20, 2012

    Report

    Report Number
    3006556115-2012-00530
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT HAS AN INFECTION AND THE PATIENT IS EXPERIENCING SORENESS AT THE IMPLANT SITE. THE PATIENT HAS BEEN INSTRUCTED TO DISCONTINUE USE OF EXTERNAL EQUIPMENT AT THIS TIME. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING FURTHER INFORMATION. ONCE MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention