BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS DUO

    MDR report key: 3920715 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14307
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DQY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE GUIDEWIRE CAUSED A SMALL DISSECTION. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396987 CPS DUO GUIDEWIRE DQY ST. JUDE MEDICAL, INC., CRMD DS2M022 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other