BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUNA THERAPY (PROSTIVA)

    MDR report key: 1037070 · Received May 1, 2008

    Report

    Report Number
    2950887-2008-02350
    Event Type
    Death
    Date Received
    May 1, 2008
    Report Date
    March 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GEI
    PMA / PMN Number
    K014224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE REFERENCE: X MARTIN, ET AL. TREATMENT OF BENIGN PROSTRATE HYPERPLASIA ( BPH) BY TRANS-URETHRAL NEEDLE ABLATION (TUNA) AND FOLLOW-UP OF RETREATMENT RATES AT 36 MOS. PROGRES EN UROLOGIE, 2005; 15:674-680. ONE PT DIED OF UNK CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNA THERAPY (PROSTIVA) GEI MEDTRONIC NEUROMODULATION 1900TU UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death