BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-06000

    MDR report key: 2151487 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06000
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE. THIS INFORMATION WAS REPORTED IN THE JOURNAL ARTICLE CARDIAC RESYNCHRONIZATION THERAPY REDUCES THE RISK OF CARDIAC EVENTS IN PATIENTS WITH DIABETES ENROLLED IN THE MADIT-CRT TRIAL. MARTIN, ET AL. JOURNAL OF THE AMERICAN HEART ASSOCIATION. (B)(6) 2011.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, THE MULTICENTER AUTOMATIC DEFIBRILLATOR IMPLANTATION TRIAL WITH CARDIAC RESYNCHRONIZATION THERAPY (MADIT-CRT), PATIENTS WITH DIABETES MELLITUS (DM) WERE COMPARED TO PATIENTS WITHOUT DM. ADVERSE EVENTS REPORTED IN THE STUDY INCLUDE PNEUMOTHORAX, HEMATOMA, RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) DISLODGEMENTS, VENOUS DISSECTION, AND SYSTEM INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O