BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALYPSO 4D LOCALIZATION SYSTEM

    MDR report key: 830765 · Received March 20, 2007

    Report

    Report Number
    3004837948-2007-00001
    Event Type
    Injury
    Date Received
    March 20, 2007
    Date of Event
    February 14, 2007
    Report Date
    March 19, 2007
    Manufacturer
    CALYPSO MEDICAL TECHNOLOGIES INC
    Product Code
    IYE
    PMA / PMN Number
    K060906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUSSION WITH FACILITY REVEALED THE PT HAD A HISTORY OF INFECTIONS AND A COMPROMISED IMMUNE SYSTEM. IT WAS DISCUSSED THAT THE INFECTION WAS BELIEVED TO BE CAUSED BY THE COMBINATION OF THE PROCEDURE TECHNIQUE AND THE PT'S HEALTH AND HAS NOTHING TO DO WITH THE PRODUCT ITSELF.

    Description of Event or Problem · 1

    TWO DAYS POST IMPLANT DEVELOPED SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALYPSO 4D LOCALIZATION SYSTEM IYE IYE CALYPSO MEDICAL TECHNOLOGIES INC ASM0094-001 00006016

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization