BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPICARDIAL LEAD TOOL

    MDR report key: 494404 · Received November 6, 2003

    Report

    Report Number
    2135394-2003-00005
    Event Type
    Injury
    Date Received
    November 6, 2003
    Report Date
    October 8, 2003
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES PT BLEEDING OCCURRED DURING ATTEMPTED IMPLANT AND HCP WAS UNABLE TO RELEASE THE LEAD FROM THE IMPLANT TOOL. THORACOTOMY WAS PERFORMED, VENTRICLE SUCCESSFULLY REPAIRED AND PT STABILIZED. MANIPULATION OF TOOL PRIOR TO IMPLANT INDICATED IT WAS IN GOOD FUNCTIONING ORDER PRIOR TO USE. A NEW LEAD WAS PLACED WITHOUT THE TOOL. NO ADDITIONAL CONSEQUENCE WAS REPORTED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICARDIAL LEAD TOOL LEAD IMPLANT TOOL DWS MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 10626 509043G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention