BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1952696 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23573
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND REPLACED WITH A CRT-D. THE PATIENT WAS HOSPITALIZED WITH THE LEFT VENTRICULAR (LV) LEAD PORT PLUGGED. THE INTRODUCER REMAINED IMPLANTED. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A PROCEDURE TO UPGRADE THIS DEVICE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), PHLEBOGRAPHY NOTED SUBCLAVIAN OCCLUSION WITH FREE BLOOD FLOW FURTHER MEDIAL. A MEDIAL SUBCLAVIAN VEIN PUNCTURE WAS ATTEMPTED. AFTER SOME TIME, A LONGER NEEDLE WAS ATTEMPTED, AND AN INTRODUCER WAS SUCCESSFULLY INSERTED. HOWEVER, THE AORTA HAD BEEN PUNCTURED. THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CLONMEL IRELAND 1860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L