BEUDAMED
    FDA Adverse Event Death Summary report: N

    BP2 ABLATION DEVICE BIOPOLAR DEVICE

    MDR report key: 6092636 · Received November 10, 2016

    Report

    Report Number
    2184009-2016-00024
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    October 17, 2013
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    GEI
    PMA / PMN Number
    K093203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KASEMSARN, CHOOSAK, MD ARTICLE TITLE: LEFT ATRIAL REDUCTION IN MODIFIED MAZE PROCEDURE WITH CONCOMITANT MITRAL SURGERY ASIAN CARDIOVASCULAR AND THORACIC ANNALS 2014: 22(4):421-9 10.1177/0218492313492438. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN DATE OF EVENT AND DEATH DATE IN OUTCOMES ATTRIBUTED TO ADVERSE EVENTS. NO UNIQUE DEVICE IDENTIFIER (SERIAL NUMBERS) WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A STUDY ON LEFT ATRIAL REDUCTION IN MODIFIED MAZE PROCEDURE WITH CONCOMITANT MITRAL SURGERY IN PATIENTS WITH PERMANENT ATRIAL FIBRILLATION WHO UNDERWENT MITRAL VALVE SURGERY AND MODIFIED BI-ATRIAL RADIOFREQUENCY ABLATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2004 AND 2011. THE STUDY POPULATION INCLUDED 236 PATIENTS PREDOMINANTLY FEMALE; MEAN AGE 51 YEARS, 93 OF WHICH WERE TREATED WITH A MEDTRONIC CARDIOBLATE BIPOLAR RADIOFREQUENCY DEVICE (SERIAL NUMBERS NOT PROVIDED). BASED ON THE AVAILABLE INFORMATION, 2 DEATHS WERE ATTRIBUTED TO AN INFARCTION WHICH CORRESPONDED TO THE PLACEMENT OF THE ABLATION LINE. AFTER THESE DEATHS OCCURRED, THE CUSTOMER ABANDONED THESE SPECIFIC LOCATIONS WHEN ABLATING FUTURE PATIENTS. THERE WERE TWO ABANDONED LINES FROM THE TRICUSPID ANNULUS AT 9 AND 12 O'CLOCK TO THE INCISION AND THE RIGHT ATRIAL APPENDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743261 BP2 ABLATION DEVICE BIOPOLAR DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC PERFUSION SYSTEMS 60831 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death