BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2103683 · Received May 3, 2011

    Report

    Report Number
    3006556115-2011-00189
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ADVANCED BIONICS, LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT DEVELOPED AN INFECTION AT THE IMPLANT SITE. THE PT WAS TREATED WITH ANTIBIOTICS (TYPE UNK) FOR 8 DAYS IN 3 CYCLES. THE PT'S DEVICE WAS EXPLANTED. THE PT'S INFECTION HAS RESOLVED.

    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 23 MO Hospitalization| R