BEUDAMED
    FDA Adverse Event Death Summary report: N

    2124215-2010-11889

    MDR report key: 1705846 · Received June 2, 2010

    Report

    Report Number
    2124215-2010-11889
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION (FROM THE PRIMARY AUTHOR OF THIS ARTICLE) REGARDING POTENTIAL BOSTON SCIENTIFIC PRODUCT INVOLVEMENT IN THE REPORTED ADVERSE EVENTS. THE LEAD AUTHOR WAS UNABLE TO CONFIRM OR REFUTE BOSTON SCIENTIFIC PRODUCT INVOLVEMENT IN THE REPORTED ADVERSE EVENTS. THE FINDINGS OF THE STUDY WERE SUMMARIZED IN THE ARTICLE: AILAWADI G, LAPAR DJ, SWENSON BR, MAXWELL CD, GIROTTI ME, BERGIN JD, KERN JA, DIMARCO JP , MAHAPATRA S. SURGICALLY PLACED LEFT VENTRICULAR LEADS PROVIDE SIMILAR OUTCOMES TO PERCUTANEOUS LEADS IN PATIENTS WITH FAILED CORONARY SINUS LEAD PLACEMENT. HEART RHYTHM. 2010 MAY; 7 (5): 619-25. (B) (4)

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS STUDY WAS CREATED TO DETERMINE IF PATIENTS WHO RECEIVE A LEFT VENTRICULAR LEAD AFTER FAILED CORONARY SINUS LEAD PLACEMENT FOR CARDIAC RESYNCHRONIZATION THERAPY DERIVE THE SAME BENEFIT AS DO PATIENTS WITH A SUCCESSFULLY PLACED CORONARY SINUS LEAD. THE STUDY INVOLVED A TOTAL OF 452 PATIENTS. BOSTON SCIENTIFIC DEVICES AND LEADS WERE IMPLANTED IN AN UNSPECIFIED NUMBER OF PATIENTS IN THIS STUDY. REPORTED ADVERSE PATIENT EFFECTS INCLUDED: ONE DEVICE POCKET INFECTION, ONE LEAD INFECTION AND ONE DEATH CAUSED BY A PRESUMED ARRHYTHMIA WITHOUT SHOCK FROM THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTB GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R