BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3040051 · Received April 3, 2013

    Report

    Report Number
    3006556115-2013-00136
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN) FOR INFECTION AND SWELLING. THE PATIENT HAS BEEN EXPLANTED AND IS DOING WELL. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE MORE INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136438 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention