BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMOTE

    MDR report key: 6124168 · Received November 21, 2016

    Report

    Report Number
    MW5066253
    Event Type
    Death
    Date Received
    November 21, 2016
    Date of Event
    July 28, 2012
    Report Date
    November 21, 2016
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MVK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FAILURE TO RESCUE THE DECAY DELAY. PT HAD AN EPISODE OF DOUBLE TACHYCARDIA (ATRIAL FIBRILLATION AND VENTRICULAR FIBRILLATION) WITH A VENTRICULAR RATE OF 270 BPM. THE DEVICE UNDERSENSED THE EPISODE AND MISCLASSIFIED A FEW BEATS AS RETURN TO SINUS RHYTHM AND SHOCK WAS NOT DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767156 PROMOTE CARDIOVERTER DEFIBRILLATOR MVK ST. JUDE MEDICAL 3207-06

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death DURATA RV-LEAD: (MODEL 7120, SN #(B)(4))| QUICK PREY LV LEAD (MODEL 1156T, SN #(B)(4))| TRENDRIL A-LEAD (MODEL 1888TC, SN # (B)(4))