BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS COURIER

    MDR report key: 2240402 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05942
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 6, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DQY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET VEIN HAD A DIFFICULT ANATOMY. THE GUIDEWIRE HAD PERFORATED THE VEIN. THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY. THE PHYSICIAN USED A CATHETER TO PLACE THE LEAD AND STABILIZED THE PATIENT. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPS COURIER GUIDEWIRE DQY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DS2G002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention