BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP CARDIAC SUMP

    MDR report key: 4080824 · Received September 4, 2014

    Report

    Report Number
    MW5038124
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    January 7, 2011
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DTS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT URGENT REPAIR OF ENLARGING ASCENDING AORTIC ANEURYSM ON (B)(6) 2011. PROCEDURE WAS UNEVENTFUL. PATIENT UNDERWENT LOWER EXTREMITY WORKUP IN (B)(6) 2014. IMAGING REVEALED CLAUDICATION IN LEFT LEG AND AN OVOID METALLIC FOREIGN BODY WITHIN THE LUMEN OF THE LEFT SUPERFICIAL ARTERY. ON (B)(6) 2014, PATIENT UNDERWENT LEFT PELVIC ANGIOGRAM, RIGHT SIDED APPROACH; LEFT SUPERFICIAL ARTERY CUTDOWN, REMOVAL OF FOREIGN BODY, INTERPOSITION SUPERFICIAL FEMORAL ARTERY-REVERSE GREATER SAPHENOUS VEIN BYPASS; HARVEST OF GREATER SAPHENOUS VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539521 DLP CARDIAC SUMP DLP CARDIAC SUMP DTS MEDTRONIC 12112 2010062157, 2010102507

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention