BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2 DR

    MDR report key: 913113 · Received September 14, 2007

    Report

    Report Number
    2124215-2007-99724
    Event Type
    Death
    Date Received
    September 14, 2007
    Date of Event
    August 17, 2007
    Report Date
    September 13, 2007
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS ICD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED, OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PASSED AWAY IN THE OPERATING ROOM AFTER THEIR DEVICE SYSTEM WAS IMPLANTED. THE REPORTED CAUSE OF DEATH WAS A MASSIVE PULMONARY EMBOLISM. ADDITIONAL SUBSEQUENT INFORMATION FROM THE PHYSICIAN STATED THAT A CLINICAL DIAGNOSIS WAS MADE THAT THE PATIENT'S DEATH WAS MOST LIKELY SECONDARY TO THE PULMONARY EMBOLISM AND INDIRECTLY BECAUSE OF THE IMPLANT PROCEDURE; HOWEVER, EVERYTHING WAS INCLUSIVE AS NO AUTOPSY WAS BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS T165

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death 4136| 0185