BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3701099 · Received March 26, 2014

    Report

    Report Number
    2950727-2014-00006
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    December 22, 2013
    Report Date
    March 21, 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

    THE CABG+TMR PROCEDURE TOOK PLACE ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2013 FOR DIZZINESS AND ON (B)(6) 2013 FOR DYSPNEA. THE PATIENT WAS ALSO DIAGNOSED WITH CONGESTIVE HEART FAILURE ON (B)(6) 2013. ACCORDING TO DOCUMENTATION, ALL AVAILABLE RECORDS SHE THE HANDPIECE WAS CORRECTLY ASSEMBLED FROM SOUND COMPONENTS AND WERE INSPECTED TO SPECIFICATIONS. HOSPITAL READMISSION RATES DUE TO HEART FAILURE FOR PATIENTS UNDERGOING CABG WITH ADJUNCTIVE TMR HAVE ALSO BEEN REPORTED; AT 30 DAYS HOSPITAL READMISSION DUE TO HEART FAILURE WAS 5% IN TMR + CABG PATIENTS AND 6% FOR PATIENTS WHO UNDERWENT CABG ALONE. HEART FAILURE IS A COMMONLY REPORTED ADVERSE EVENT AFTER CABG PROCEDURES WITH OR WITHOUT ADJUNCTIVE TMR. THIS PATIENT'S PRE-OPERATIVE MEDICAL HISTORY INCLUDED VARIOUS RISK FACTORS THAT MAY INCREASE THE RISK OF HEART FAILURE AFTER CABG.

    Description of Event or Problem · 1

    THE CABG+TMR PROCEDURE TOOK PLACE ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2013 FOR DIZZINESS AND ON (B)(6) 2013 FOR DYSPNEA. THE PATIENT WAS ALSO DIAGNOSED WITH CONGESTIVE HEART FAILURE ON (B)(6) 2013.

    Description of Event or Problem · 1

    THE CABG+TMR PROCEDURE TOOK PLACE ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2013 FOR DIZZINESS AND ON (B)(6) 2013 FOR DYSPNEA. THE PATIENT WAS ALSO DIAGNOSED WITH CONGESTIVE HEART FAILURE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177743 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other