BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7051452 · Received November 21, 2017

    Report

    Report Number
    9612164-2017-01644
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    November 24, 2015
    Report Date
    November 21, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNET BLOG ADDRESS: (B)(6) APPROXIMATE DATES.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED, INFORMATION OBSERVED ON THE INTERNET AS A RESULT OF READING AN ARTICLE BY DR (B)(6). IN RESPONSE TO THE ARTICLE, A PATIENT ENTERED A COMMENT. THE PATIENT HAS A FAMILY HISTORY OF VARICOSE VEINS, AND DESCRIBED HAVING THE VENASEAL PROCEDURE. THE PATIENT HAD BOTH LEGS TREATED AND REPORTED HAVING DEVELOPED SEVERE PHLEBITIS ON ONE LEG. THE PATIENT WAS TREATED WITH ANTIBIOTICS, ANTI-INFLAMMATORY MEDICATION, CORTISONE AND PAIN KILLERS. THE TREATMENT REDUCED THE SWELLING AND PAIN TEMPORARILY, NOW 9 WEEKS POST PROCEDURE THE HARD LUMPS REMAIN, AND THE PAIN HAS BECOME SEVERE DUE TO AN INFECTION. THE PATIENT WAS TREATED WITH A NEW COURSE OF ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICATION. THE PATIENT HAS REPORTED HAVING A GAPING WOUND THAT IS DIFFICULT TO HEAL. THE WOUND IS NOT AT THE ENTRANCE SITE, IT IS FURTHER ALONG THE VEIN TRACK. THE PATIENT ALSO REPORTED THE APPEARANCE OF THE VARICOSE VEINS HAVE LESSENED BUT NOT COMPLETELY, AND AN ULTRASOUND CONFIRMED THE CLOSURE OF THE MAIN VEINS WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827906 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention