BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1211099 · Received October 24, 2008

    Report

    Report Number
    3005099803-2008-05521
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    December 21, 2007
    Report Date
    September 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2007. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, PT WAS GIVEN PROSED DS TO TREAT BLADDER SPASMS AND TO TREAT URETHRAL DISCOMFORT. BOTH THE BLADDER SPASMS AND THE URETHRAL DISCOMFORT ARE NOTED TO BE MODERATE IN INTENSITY. THE PT'S DYSURIA STARTED IN 2008, NO TREATMENT WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH THIS PROLIEVE THERMODILITATION KIT. THE PT'S CONDITION WAS REPORTED AS "ON-GOING", AS FURTHER MEDICAL INTERVENTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000603307

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention