BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 2142535 · Received June 28, 2011

    Report

    Report Number
    2124215-2011-11103
    Event Type
    Death
    Date Received
    June 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A PROCEDURE TO IMPLANT A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT EXPERIENCED ELECTROMECHANICAL DISSOCIATION WITH LOW OXYGEN SATURATION LEVELS WHEN A SUTURE FOR THE LEFT VENTRICULAR (LV) LEAD WAS BEING PLACED. THE PATIENT RECOVERED AFTER 40 MINUTES OF RESUSCITATION. THE PATIENT THEN EXPERIENCED FAST VENTRICULAR TACHYCARDIA (VT) AND REQUIRED EXTERNAL SHOCKS. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITH THIS PACEMAKER. THE PATIENT WAS HOSPITALIZED. WHILE HOSPITALIZED, THE PATIENT HAD A CARDIAC ARREST AND DIED. THE PHYSICIAN BELIEVED THE IMPLANTED SYSTEM DID NOT DIRECTLY CAUSE THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S504

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O| R