BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1843479 · Received September 22, 2010

    Report

    Report Number
    2953200-2010-01799
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (PARALYSIS).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROX 1 MONTH AGO. THERE WERE NO COMPLICATIONS NOTED DURING ADVANCEMENT OF THE DEVICE THROUGH THE VESSELS. SPINAL DRAIN WAS PERFORMED AFTER THE STENT GRAFTS WERE IMPLANTED. IT WAS REPORTED THAT THE PT HAD PARALYSIS WHEN SHE WOKE UP FROM ANESTHESIA. THE PT WAS STARTED ON REHABILITATION AND WAS ABLE TO STAND AND WALK WITH A WALKER (SEE MFR # 2953200-2010-01800). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00480638

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention