BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 1523241 · Received October 30, 2009

    Report

    Report Number
    3007566237-2009-07922
    Event Type
    Injury
    Date Received
    October 30, 2009
    Date of Event
    July 15, 2009
    Report Date
    October 12, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: SAVOIE PH. LOPEZ L. SIMONIN O. ET AL. [MEDIUM-TERM RESULTS (2 YEARS) OF RADIOFREQUENCY (TUNA) FOR LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA.] PROG UROL. 2009; 19(7):501-6. SUMMARY: THIS ARTICLE PRESENTS THE MEDIUM-TERM FUNCTIONAL RESULTS OF TRANSURETHRAL NEEDLE ABLATION TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) RESISTANT TO MEDICAL TREATMENT. FORTY FIVE PTS WERE TREATED BETWEEN 2002 AND 2005, 27 WERE FOLLOWED FOR MORE THAN 24 MONTHS. PTS WERE ASSESSED PREOPERATIVELY AND THEN SIX AND 24 MONTHS POSTOPERATIVELY. REPORTABLE EVENT: THREE PTS REQUIRED AN ADDITIONAL TREATMENT BY FACILITY BETWEEN SIX AND 24 MONTHS AFTER THE INITIAL PROCEDURE. THE INITIAL TREATMENT WAS CONSIDERED TO BE A FAILURE. SEE LITERATURE ARTICLE WITH MFR REPORT #3007566237-2009-07916.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MEDTRONIC NEUROMODULATION 8929 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR: MODEL 8930, LOT # UNKNOWN