BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 4024085 · Received August 20, 2014

    Report

    Report Number
    2950727-2014-00016
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    May 20, 2014
    Report Date
    August 18, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 15 CHANNELS PLACED. THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON (B)(6) 2014. ACCORDING TO DOCUMENTATION, ALL AVAILABLE RECORDS THE HANDPIECE WAS CORRECTLY ASSEMBLED FROM APPROVED COMPONENTS AND WERE INSPECTED TO SPECIFICATIONS. ATRIAL FIBRILLATION IS A COMMON EARLY ADVERSE EVENT AFTER CORONARY ARTERY BYPASS GRAFT PROCEDURES WITH OUR WITHOUT ADJUNCTIVE TMR. THIS IS NOT UNEXPECTED EVENT AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 15 CHANNELS PLACED. THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON (B)(6) 2014.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 15 CHANNELS PLACED. THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503026 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARLIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other