BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3500517 · Received December 4, 2013

    Report

    Report Number
    2938836-2013-09294
    Event Type
    Death
    Date Received
    December 4, 2013
    Date of Event
    November 12, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 WAS IN THE HOSPITAL WHEN SHE WENT INTO VENTRICULAR FIBRILLATION (VF). THE DEVICE AND THE LEAD SYSTEM FAILED TO RESCUE THE PATIENT. THE PATIENT WAS IN VF FOR THREE MINUTES BEFORE BEING EXTERNALLY RESCUED. UPON DEVICE INTERROGATION, AN ALERT FOR LOW OUT OF RANGE HV LEAD IMPEDANCE AND POSSIBLE HV LEAD ISSUE WERE OBSERVED. THE PATIENT WAS INTUBATED. IT WAS REPORTED THAT THE PATIENT WAS NOT DOING WELL AND THE PHYSICIAN ELECTED TO PROGRAM HV THERAPY OFF. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627802 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death (B)(4)