BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY¿ ABLATION SYSTEM

    MDR report key: 12605208 · Received October 11, 2021

    Report

    Report Number
    3011706110-2021-00043
    Event Type
    Death
    Date Received
    October 11, 2021
    Date of Event
    September 17, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCM
    UDI-DI
    00818354010503
    PMA / PMN Number
    P100046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CASE-(B)(4) UPDATED FIELDS B2 AND H1 AS IT WAS LATER LEARNED THAT THE PATIENT EXPIRED. THERE IS NO CAUSE OF DEATH AND NO AUTOPSY RESULTS.

    Additional Manufacturer Narrative · 0

    CASE- (B)(4) THE OLL2 DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 111400. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, AN (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT AN ON-PUMP, HEPARINIZED INTRA-AORTIC BALLOON PUMP INSERTION, MAMMARY TAKE DOWN, TRIPLE CORONARY ARTERY BYPASS GRAFT, BI-ATRIAL MAZE, A LEFT ATRIAL APPENDAGE LIGATION, AND AORTIC VALVE REPLACEMENT. UPON COMPLETION OF THESE PROCEDURES WHILE COMING OFF CARDIOPULMONARY BYPASS, BLEEDING WAS NOTED. THE PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS, AND THE HEART WAS RE-ARRESTED TO REPAIR THE LEFT ATRIAL ROOF LINE. PATIENT WAS STABLE POST-PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506697 SYNERGY¿ ABLATION SYSTEM SYNERGY¿ ABLATION SYSTEM OCM ATRICURE, INC. OLL2 111400 00818354010503

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Life Threatening| R| D CRYO2, PROV50, ASU/ASB.