BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3851152 · Received May 23, 2014

    Report

    Report Number
    3006556115-2014-00247
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 11, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY DEVELOPED AN INFECTION AND EXPERIENCED DRAINAGE AND SKIN EROSION, EXPOSING THE INTERNAL DEVICE. THE PATIENT'S DEVICE WAS EXPLANTED. THE INFECTION HAS RESOLVED. REIMPLANTATION SURGERY IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309204 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Required Intervention