BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DECAPOLAR CATHETER

    MDR report key: 8019900 · Received October 30, 2018

    Report

    Report Number
    2134265-2018-62401
    Event Type
    Death
    Date Received
    October 30, 2018
    Date of Event
    June 1, 2004
    Report Date
    October 30, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KIM, DONG-HYEOK ET AL. (2018) LONG-TERM CLINICAL OUTCOMES OF CATHETER ABLATION IN PATIENTS WITH ATRIAL FIBRILLATION PREDISPOSING TO TACHYCARDIA-BRADYCARDIA SYNDROME: A LONG PAUSE PREDICTS IMPLANTATION OF A PERMANENT PACEMAKER. BMC CARDIOVASCULAR DISORDERS, 18:106. HTTPS://DOI.ORG/10.1186/S12872-018-0834-0. EVENT DATE: ESTIMATION BASED ON EARLIEST ENROLLMENT DATE.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. THE ARTICLE DESCRIBES A STUDY AIMED TO INVESTIGATE LONG-TERM CLINICAL OUTCOMES OF CATHETER ABLATION IN PATIENTS WITH TBS AND AF. AMONG 145 CONSECUTIVE PATIENTS WHO UNDERWENT CATHETER ABLATION OF AF WITH TBS, 121 PATIENTS WERE STUDIED. AMONG 121 PATIENTS, 11 (9.1%) RECEIVED IMPLANTATION OF A PERMANENT PACEMAKER DURING A MEAN 21 MONTHS AFTER ABLATION. LENGTH OF PAUSE ON TERMINATION OF AF WAS SIGNIFICANTLY GREATER IN PATIENTS WHO RECEIVED PACEMAKER IMPLANTATION AFTER ABLATION THAN THOSE WHO UNDERWENT ABLATION ONLY. USING A MULTIVARIATE MODEL, A LONG PAUSE OF 6.3 S OR LONGER AFTER TERMINATION OF AF WAS ASSOCIATED WITH THE REQUIREMENT TO IMPLANT A PERMANENT PACEMAKER AFTER ABLATION. THIS STUDY SUGGESTS THAT, IN PATIENTS WITH AF PREDISPOSING TO TBS, LONG PAUSE ON TERMINATION OF AF PREDICTS THE NEED TO IMPLANT A PERMANENT PACEMAKER AFTER CATHETER ABLATION. THE SOURCE LITERATURE REPORTED A DECAPOLAR CATHETER WAS POSITIONED IN THE HIGH RIGHT ATRIUM DURING THE ABLATION PROCEDURES. OF 121 PATIENTS, ONE PATIENT DEATH OCCURRED, AS WELL AS SIX CASES OF CARDIAC TAMPONADE, AND FOUR PATIENTS WHO EXPERIENCED STROKE. TWO OF THE PATIENTS WHO EXPERIENCED STROKE WERE ALSO HOSPITALIZED. TWO GROIN HEMATOMAS ALSO OCCURRED; HOWEVER, IT WAS UNKNOWN IF THE HEMATOMAS REQUIRED INTERVENTION. MEAN PATIENT AGE WAS 61.1 YEARS, AND THE PATIENT POPULATION WAS 64% MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859324 UNKNOWN DECAPOLAR CATHETER DRF BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O