BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3787603 · Received May 2, 2014

    Report

    Report Number
    2950727-2014-00011
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 30, 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

    ACCORDING TO THE REPORT, A (B)(6) FEMALE UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 17 CHANNELS PLACED. THE PATIENT EXPERIENCED ATRIAL FIBRILLATION THE SAME DAY. A REVIEW OF MANUFACTURING AND INSPECTION RECORDS FROM EACH POSSIBLE LOT WAS PERFORMED AND ALL COMPONENTS WERE FOUND TO MEET SPECIFICATION. ATRIAL FIBRILLATION IS A COMMON EARLY ADVERSE EVENT AFTER CORONARY ARTERY BYPASS GRAFT PROCEDURES WITH OR WITHOUT ADJUNCTIVE TMR. ADEQUATE PRECAUTIONS AND WARNINGS ARE PRESENT IN THE PRODUCT'S INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A (B)(6) FEMALE UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 17 CHANNELS PLACED. THE PATIENT EXPERIENCED ATRIAL FIBRILLATION THE SAME DAY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A (B)(6) LD FEMALE UNDERWENT A CABG+TMR PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 17 CHANNELS PLACED. THE PATIENT EXPERIENCED ATRIAL FIBRILLATION THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266084 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other