BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 976561 · Received January 8, 2008

    Report

    Report Number
    2182207-2008-00070
    Event Type
    Injury
    Date Received
    January 8, 2008
    Report Date
    October 26, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    KNS
    PMA / PMN Number
    K960918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE DATES OF THERAPY DELIVERY (1996 THRU 1999), THE MOST LIKELY MODEL NUMBER FOR THE CARTRIDGE (HANDPIECE) IS THE TUNA 3.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: OHIGASHI ET AL. "LONG TERM RESULTS OF THREE DIFFERENT MINIMALLY INVASIVE THERAPIES FOR LOWER URINARY TRACT SYMPTOMS DUE TO BENIGHN PROSTATIC HYPERPLSIA: COMPARISON AT A SINGLE INSTITUTE" INTERNATIONAL JOURNAL OF UROLOGY (2007) 14, 326, 330. THE ARTICLE DESCRIBES A LONG TERM RETROSPECTIVE STUDY WHERE 29 PTS WERE TREATED WITH TUNA THERAPY FOR BPH SYMPTOMS. A NUMBER OF PT COMPLICATIONS WERE REPORTED. REPORTABLE EVENT: ONE PT EXPERIENCED POST OPERATIVE PERSISTENT PYURIA. TREATMENT AND ADD'L OUTCOME INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK KNS KNS MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other RF GENERATOR| RETURN ELECTRODE