BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3235668 · Received July 18, 2013

    Report

    Report Number
    2950727-2013-00041
    Event Type
    Death
    Date Received
    July 18, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 18, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED IS ACCURATE OR HAS BEEN CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ANGINA RELIEF REGISTRY INDICATES THAT A PATIENT RECEIVED TMR ON (B)(6) 2013. THE PATIENT WAS FOUND DECEASED BY WIFE ON (B)(6) 2013. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334749 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3

    Patients

    Seq Age Sex Outcome Treatment
    1 Death