BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_NAVISTAR

    MDR report key: 8112168 · Received November 28, 2018

    Report

    Report Number
    2029046-2018-02336
    Event Type
    Death
    Date Received
    November 28, 2018
    Date of Event
    July 2, 2013
    Report Date
    October 30, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS THAT USED IN THIS STUDY: CARTO3, NAVISTAR, THERMOCOOL, THERMOCOOL SF, NAVISTAR RMT. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NAVX (ST. JUDE), CHILLI (BS). MANUFACTURER'S REF. NO: (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2018-02326, 2029046-2018-02327, 2029046-2018-02328, 2029046-2018-02329, 2029046-2018-02330, 2029046-2018-02331, 2029046-2018-02332, 2029046-2018-02334, 2029046-2018-02333, 2029046-2018-02335, 2029046-2018-02338 ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    "EVENT DESCRIPTION: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: 137 PATIENTS UNDERWENT CATHETER ABLATION OF NON-ISCHEMIC VENTRICULAR FIBRILLATION AND DIED DURING FOLLOW UP. NO ADDITIONAL DETAILS WERE PROVIDED. MULTIPLE REQUESTS FOR CLARIFICATION HAVE BEEN SENT TO THE CORRESPONDING AUTHOR, BUT NO ADDITIONAL DETAILS WERE PROVIDED AT THIS TIME. IF ADDITIONAL DETAILS WILL BE PROVIDED THIS REPORT WILL BE UPDATED ACCORDINGLY. THE SUSPECTED DEVICE IS THERMOCOOL SF. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3, NAVISTAR, THERMOCOOL, THERMOCOOL SF, NAVISTAR RMT. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NAVX (ST. JUDE), CHILLI (BS). "PUBICATION" DETAILS: TITLE: OUTCOMES OF CATHETER ABLATION OF VENTRICULAR TACHYCARDIA BASED ON ETIOLOGY IN NONISCHEMIC HEART DISEASE. OBJECTIVE: THE AIM OF THIS STUDY WAS TO CHARACTERIZE VENTRICULAR TACHYCARDIA (VT) ABLATION OUTCOMES ACROSS NONISCHEMIC CARDIOMYOPATHY (NICM) ETIOLOGIES AND ADJUST THESE OUTCOMES BY PATIENT-RELATED COMORBIDITIES THAT COULD EXPLAIN DIFFERENCES IN ARRHYTHMIA RECURRENCE RATES. METHODS: DATA FROM 780 PATIENTS WITH STRUCTURAL HEART DISEASE REFERRED FOR CATHETER ABLATION OF VT FROM 12 INTERNATIONAL CENTERS WAS RETROSPECTIVELY ANALYZED. PATIENT CHARACTERISTICS AND OUTCOMES WERE NOTED FOR THE 6 MOST COMMON NONISCHEMIC CARDIOMYOPATHY ETIOLOGIES. MULTIVARIABLE COX PROPORTIONAL HAZARDS MODELING WAS USED TO ADJUST FOR POTENTIAL CONFOUNDERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949959 UNK_NAVISTAR UNK_NAVISTAR LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death CARTO3