BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3770030 · Received April 24, 2014

    Report

    Report Number
    2950727-2014-00009
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 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 EVENT WAS REPORTED THROUGH THE (B)(4) REGISTRY. THE (B)(6) PATIENT UNDERWENT THE TMR+CABG PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 18 CHANNELS PLACED. THE PATIENT EXPERIENCED VENTRICULAR ARRHYTHMIA THE SAME DAY. THE NON SUSTAINED VENTRICULAR TACHYCARDIA WAS SUCCESSFULLY TREATED WITH AMIODARONE. A REVIEW OF MANUFACTURING AND INSPECTION RECORDS FROM EACH POSSIBLE LOT WAS PERFORMED AND ALL COMPONENTS WERE FOUND TO MEET SPECIFICATION. VENTRICULAR ARRHYTHMIA 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, THE (B)(6) PATIENT UNDERWENT THE TMR+CABG PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 18 CHANNELS PLACED. THE PATIENT EXPERIENCED VENTRICULAR ARRHYTHMIA THE SAME DAY. THE NON SUSTAINED VENTRICULAR TACHYCARDIA WAS SUCCESSFULLY TREATED WITH AMIODARONE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE (B)(6) PATIENT UNDERWENT THE TMR+CABG PROCEDURE ON (B)(6) 2014 WITH A TOTAL OF 18 CHANNELS PLACED. THE PATIENT EXPERIENCED VENTRICULAR ARRHYTHMIA THE SAME DAY. THE NON SUSTAINED VENTRICULAR TACHYCARDIA WAS SUCCESSFULLY TREATED WITH AMIODARONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249853 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-04026

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other