BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER® II XP

    MDR report key: 3201861 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04475
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE THE PATIENT DEVELOPED 'ATYPICAL' ATRIAL FLUTTER AND ATRIAL FIBRILLATION. DURING THE TREATMENT PROCEDURE, THE PATIENT SPONTANEOUSLY DEVELOPED ATYPICAL ATRIAL FLUTTER AND ATRIAL FIBRILLATION. IT WAS ATTEMPTED TO CONVERT THE PATIENT USING PROCAINAMIDE 500 MG AND REPEATED EXTERNAL CARDIOVERSIONS. THE LINE OF BLOCK COULD NOT BE FULLY ASSESSED BECAUSE OF THE EPISODES OF EARLY RECURRENCE OF ATRIAL FIBRILLATION. THE PATIENT WAS STARTED ON BETAPACE AND REMAINED IN ATRIAL FIBRILLATION AT THE END OF THE STUDY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302144 BLAZER® II XP CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M0044500THK20 5847314

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other