BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2 DR

    MDR report key: 1036865 · Received May 1, 2008

    Report

    Report Number
    2124215-2008-99889
    Event Type
    Death
    Date Received
    May 1, 2008
    Date of Event
    April 9, 2008
    Manufacturer
    GUIDANT
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. IT WAS NOT KNOWN IF THIS DEVICE WAS GOING TO BE EXPLANTED. A REQUEST WAS MADE TO HAVE THIS PRODUCT RETURNED FOR ANALYSIS IF IT WAS EXPLANTED. AS A RESULT, BOSTON SCIENTIFIC IS UNABLE TO CONFIRM ANY ALLEGATIONS AGAINST THIS PRODUCT. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ADDITIONAL INFO IS REC'D.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC, CRM RECEIVED INFO THAT THE PT WITH THIS DEVICE PASSED AWAY. THE PT'S FAMILY WAS CONCERNED THAT THE DEVICE WAS PROGRAMMED OFF AT THE TIME OF DEATH AND THREATENED LEGAL ACTION. UPON INTERROGATION, IT WAS CONFIRMED THAT THE DEVICE WAS ON, AS IT WAS PROGRAMMED TO MONITOR + THERAPY. TWO EPISODES WERE STORED ON THE DATE OF THE PT'S DEATH. A BOSTON SCIENTIFIC TECHNICAL WAS A NON-SUSTAINED EPISODE, AND THE OTHER HAD TWO BURSTS OF ANTI-TACHYCARDIA PACING, WHICH RESULTED IN AN AGONAL-TYPE RHYTHM THAT THE DEVICE UNDERSENSED. THE VENTRICULAR SENSITIVITY WAS PROGRAMMED TO LEAST. TS ALSO NOTED EPISODES OF T-WAVE OVERSENSING IN 2007, WHICH RESULTED IN INAPPROPRIATE THERAPY. TS SUSPECTED THIS MAY HAVE BEEN WHY THE DEVICE WAS PROGRAMMED TO LEAST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death