BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 10536591 · Received September 15, 2020

    Report

    Report Number
    2029046-2020-01241
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    June 9, 2013
    Report Date
    August 27, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). 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 LOT NUMBER WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 1 PATIENT UNDERWENT CATHETER ABLATION AND SUFFERED TRANSIENT ISCHEMIC ATTACK DURING THE ABLATION PROCEDURE. INTERVENTION WAS NOT REPORTED. THERE ARE 0 DEATH EVENTS AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS LASSO. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: INQUIRYTM LUMA-CATHTM, 7F BLAZER II, BARD ELECTROPHYSIOLOGY , EP MED SYSTEM, INC PUBLICATION DETAILS TITLE: THE ROLE OF SUCCESSFUL CATHETER ABLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION AND PROLONGED SINUS PAUSES: OUTCOME DURING A 5-YEAR FOLLOW-UP OBJECTIVE: ALTHOUGH PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (AF) AND PROLONGED SINUS PAUSES [TACHYCARDIA ¿BRADYCARDIA SYNDROME (TBS)] ARE GENERALLY TREATED BY PERMANENT PACEMAKER, CATHETER ABLATION HAS BEEN REPORTED TO BE A CURATIVE THERAPY FOR TBS WITHOUT PACEMAKER IMPLANTATION. THE PURPOSE OF THIS STUDY WAS TO DEFINE THE POTENTIAL ROLE OF SUCCESSFUL ABLATION IN PATIENTS WITH TBS. METHODS: OF 280 PAROXYSMAL AF PATIENTS UNDERGOING ABLATION, 37 TBS PATIENTS WITH BOTH AF AND SYMPTOMATIC SINUS PAUSES (AGE: 62+8 YEARS; MEAN MAXIMUM PAUSES: 6+2 S) WERE ANALYSED. DURING THE 5.8+1.2 YEARS (RANGE: 5¿8.7 YEARS) FOLLOWUP, BOTH TACHYARRHYTHMIA AND BRADYCARDIA WERE ELIMINATED BY A SINGLE PROCEDURE IN 19 OF 37 (51%) PATIENTS. REPEAT PROCEDURES WERE PERFORMED IN 14 OF 18 PATIENTS WITH TACHYARRHYTHMIA RECURRENCE (SECOND: 12 AND THIRD: 2 PATIENTS). DURING THE REPEAT PROCEDURE, 79% (45 OF 57) OF PREVIOUSLY ISOLATED PULMONARY VEINS (PVS) WERE RECONNECTED TO THE LEFT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002669 UNK_LASSO UNK DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other 7F BLAZER II| BARD ELECTROPHYSIOLOGY| EP MED SYSTEM, INC| INQUIRYTM LUMA-CATHTM