BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_NAVISTAR THERMOCOOL

    MDR report key: 8113367 · Received November 28, 2018

    Report

    Report Number
    2029046-2018-02350
    Event Type
    Death
    Date Received
    November 28, 2018
    Date of Event
    August 31, 2017
    Report Date
    November 1, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: CARTO, LASSO, PENTARAY NAV, VISITAG. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: DAIG DUODECA 2-10-2, (ST. JUDE). MANUFACTURER'S REF. NO: (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2018-02349 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: 1 PATIENT UNDERWENT CATHETER ABLATION OF ATRIAL "FIBRILLAITON" AND DIED 53 DAYS POST-PROCEDURE OF NON-CARDIAC REASON. NO FURTHER 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. THERE ARE 2 DEATH EVENTS AND 0 DEVICE MALFUNCTION EVENTS REPORTED IN THIS PUBLICATION. THE SUSPECTED DEVICE IS NAVISTAR THERMOCOOL MODEL AND CATALOG NUMBER ARE NOT AVAILABLE. OTHER BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. PUBLICATION DETAILS: TITLE: POSITIVE IMPACT OF PULMONARY VEIN ISOLATION ON BIVENTRICULAR PACING IN NON-RESPONDERS TO CARDIAC RESYNCHRONIZATION THERAPY (CRT). OBJECTIVE: TO INVESTIGATE THE EFFECTS OF CATHETER ABLATION IN AF PATIENTS WITH NON-RESPONSE TO CRT. METHODS: 38 CONSECUTIVE PATIENTS WITH DOCUMENTED ATRIAL FIBRILLATION AND CRT NON-RESPONSE THAT UNDERWENT CATHETER ABLATION FOR AF BETWEEN JANUARY 2010 AND AUGUST 2017 WERE INCLUDED IN THIS RETROSPECTIVE ANALYSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948939 UNK_NAVISTAR THERMOCOOL UNK_NAVISTAR THERMOCOOL OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death