BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS DIRECT SL II

    MDR report key: 2983901 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01619
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 23, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DQY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE CATHETER DISSECTED THE CORONARY SINUS. THE PHYSICIAN CHECKED THE PATIENT AND NO PLEURAL SPILL WAS FOUND. THE PATIENT WAS IN -GOOD- CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88594 CPS DIRECT SL II CATHETER DQY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DS2C001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention