BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1201487 · Received October 17, 2008

    Report

    Report Number
    3006556115-2008-00541
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY DEVELOPED AN INFECTION 3 WEEKS AFTER INITIAL IMPLANTATION. SKIN IRRITATION FROM HEADPIECE USE WAS NOT OBSERVED. THE PT WAS PRESCRIBED ANTIBIOTICS (AMOXICILLIN SUSR). THE PT CONTINUES TO BE MONITORED BY THE CENTRE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFO IS OBTAINED.

    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