BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7078594 · Received December 4, 2017

    Report

    Report Number
    9612164-2017-01709
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PRIMARY DIAGNOSIS OF PATIENT'S CONDITION WAS FOREIGN BODY RESPONSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT WAS TREATED WITH 2.7 CC OF VENA SEAL TREATMENT FOR A VENOUS INSUFFICIENCY IN THE RIGHT GSV (75 CM) ON THE (B)(6) 2017. THE PATIENT TOOK ALEVE THE EVENING PRIOR TO THE PROCEDURE THE DAY OF, AND THE DAY AFTER THE PROCEDURE. ROUTINE FOLLOW UP LOWER EXTREMITY VENOUS DUPLEX PERFORMED APPROXIMATELY 1 WEEK POST THE PROCEDURE WAS NEGATIVE FOR DVT AND SHOWED COMPLETE CLOSURE OF THE TREATED VEIN. ON THE (B)(6) 2017 THE PATIENT STARTED TO EXPERIENCE RED, ITCHY LOWER EXTREMITIES IN AREAS OF VENASEAL CLOSURE TREATMENT. IT WAS REPORTED THAT THERE WAS NO INFECTION. THE PATIENT TOOK BENADRYL AND ALEVE WITH NO RELIEF. THE TREATING PHYSICIAN, PRESCRIBED A MEDROL DOSEPAK ON THE (B)(6) 2017. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860182 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND 43112

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention