BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1952729 · Received January 5, 2011

    Report

    Report Number
    MW5018875
    Event Type
    Death
    Date Received
    January 5, 2011
    Date of Event
    June 29, 1999
    Report Date
    December 23, 2010
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN(S) WHO IS RESPONSIBLE FOR THE PROCEDURE(S) IS (B)(6) AND/OR DR (B)(6). (B)(6) AND/OR (B)(6), FILED (B)(6) HOSPITAL DISTRICT HEALTH DEPARTMENT COMPLAINT. THE PHYSICIAN(S) WHO IS RESPONSIBLE FOR THE PROCEDURE(S) IS DR (B)(6), MEDICAL BOARD MISCONDUCT, RE: (B)(6). (B)(6) HOSPITAL CONSENT FOR CARDIAC CATHETERIZATION PROCEDURES ON (B)(6) 1999 FOR CORONARY ANGIOPLASTY, INTRA-CORONARY STENT, ROTATIONAL/DIRECTIONAL ATHERECTOMY, INTRAVASCULAR ULTRASOUND STUDY, OR CORONARY BYPASS GRAFT PROCEDURE AS INDICATED MEDICAL BOARD MISCONDUCT DEFECTS/MALFUNCTIONS AICD MEPHYTON PRESCRIBED OVER MEDICATION AT (B)(6), (B)(6) PREMEDITATED. STRENGTH: WEAK LED TO THREE CARDIAC FATAL RHYTHMS. EVENT ABATED AFTER USE: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC GUIDANT AICD AUTOMATIC IMPLANTABLE DEV. DEFIBRILLATOR LWS 1831

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AMIODARONE 200MG, TAKE 1 TAB, (B)(6), (B)(6)| EXPIRATION DATE: 02/05/2010| EXPIRATION DATE: 02/02/2009| MEPHYTON 5MG, TAKE 1/2 TAB, (B)(6), (B)(6)| CONSENT ANGIOPLASTY, (B)(6)| AICD WRONG DEVICE SURGERY, (B)(6)