BEUDAMED
    FDA Adverse Event Death Summary report: N

    THINLINE

    MDR report key: 1053113 · Received May 28, 2008

    Report

    Report Number
    2124215-2008-99905
    Event Type
    Death
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ITM
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. ACCORDING TO AVAILABLE INFO, THE DEVICE WAS REMOVED AND WILL BE RETURNED FOR ANALYSIS; HOWEVER THE RIGHT VENTRICULAR LEAD DISPOSITION IS UNK AT THIS TIME. WHEN THE DEVICE HAS BEEN RETURNED AND ANALYZED, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PT WITH THIS DEVICE AND RIGHT VENTRICULAR LEAD EXPIRED. DEVICE INTERROGATION REVEALED NORMAL DAILY MEASUREMENTS, HOWEVER IMPEDANCE MEASUREMENTS WERE GREATER THAT 2500 OHMS. THERE WAS NO KNOWN REASON FOR THE DEVICE OR LEAD INVOLVEMENT IN THE PT'S DEATH. THE BOSTON SCIENTIFIC FIELD REP INDICATED THIS SYSTEM COULD BE A CONTRIBUTING FACTOR TO THIS PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE IMPLANTABLE LEAD DTB ITM 430-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death