BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENEWAL 3

    MDR report key: 637819 · Received February 9, 2004

    Report

    Report Number
    2124215-2004-06581
    Event Type
    Death
    Date Received
    February 9, 2004
    Date of Event
    November 12, 2003
    Report Date
    November 12, 2003
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) AND LEAD SYSTEM (GUIDANT TRANSVENOUS DEFIBRILLATION AND CORONARY SINUS LEADS) WAS HOSPITALIZED FOR END-STAGE HEART FAILURE WITH AN ELECTROLYTE IMBALANCE. THE PATIENT EXPERIENCED SEVERAL EPISODES OF SPONTANEOUS VENTRICULAR FIBRILLATION (VF). REVIEW OF ELECTROGRAMS REVEALED SOME UNDERSENSING OF FINE VF; THE RHYTHM WAS INAPPROPRIATELY DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). THE PATIENT WAS EXTERNALLY RESCUED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEWAL 3 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H179 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death