BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3953917 · Received July 23, 2014

    Report

    Report Number
    2182208-2014-01868
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. EXACT DATES OF DEATH ARE UNKNOWN AND IS ESTIMATED BASED ON THE PUBLICATION DATE. REFERENCED ARTICLE: DETERMINANTS OF ALL-CAUSE MORTALITY IN DIFFERENT AGE GROUPS IN PATIENTS WITH SEVERE SYSTOLIC LEFT VENTRICULAR DYSFUNCTION RECEIVING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (FROM THE ITALIAN CLINICAL SERVICE MULTICENTER OBSERVATIONAL PROJECT). AMERICAN JOURNAL OF CARDIOLOGY. 2014;113(10):1691-1696. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE JOURNAL ARTICLE REPORTED A TOTAL OF 685 OVER THE COURSE OF THE STUDY. CAUSES OF DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431674 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death