BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 3953196 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13549
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    June 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO VF THAT BECAME FINE IN APPEARANCE AND WAS SUBSEQUENTLY UNDERSENSED. REVIEW OF EGM REMOTE TRANSMISSIONS REVEALED THAT THE PATIENT HAD INITIALLY RECEIVED AN APPROPRIATE BUT DELAYED SHOCK. SUBSEQUENT EPISODES WERE DIAGNOSED AS SUPRAVENTRICULAR TACHYCARDIA, VT/VF WITH ATP THERAPY, OR RETURN TO SINUS DUE TO THE UNDERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431586 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death