BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III

    MDR report key: 3701496 · Received March 26, 2014

    Report

    Report Number
    2950727-2014-00007
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    January 30, 2014
    Report Date
    March 21, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON DAY 2 AFTER THE TMR PROCEDURE. ADDITIONALLY, THE PATIENT EXPERIENCED AN UPPER GI BLEED ON (B)(6) 2014. THE PATIENT WAS ANGINA-FREE AT 30 DAYS. ACCORDING TO DOCUMENTATION, ALL AVAILABLE RECORDS SHE THE HANDPIECE WAS CORRECTLY ASSEMBLED FROM SOUND COMPONENTS AND WERE INSPECTED TO SPECIFICATIONS. ATRIAL FIBRILLATION IS A COMMON EARL ADVERSE EVENT AFTER CORONARY ARTERY BYPASS GRAFT PROCEDURES WITH OUR WITHOUT ADJUNCTIVE TMR. THIS IS NOT UNEXPECTED EVENT TWO DAYS AFTER THE PROCEDURE. UPPER GI BLEED WAS A RESULT OF EROSIVE ESOPHAGITIS AS CONFIRMED BY ENDOSCOPY AND IS UNRELATED TO THE TMR PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON DAY 2 AFTER THE TMR PROCEDURE. ADDITIONALLY, THE PATIENT EXPERIENCED AN UPPER GI BLEED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON DAY 2 AFTER THE TMR PROCEDURE. ADDITIONALLY, THE PATIENT EXPERIENCED AN UPPER GI BLEED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177829 SOLOGRIP III TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-04000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other