BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILATATION SYSTEM, REFURBISHED

    MDR report key: 1551834 · Received November 23, 2009

    Report

    Report Number
    3005099803-2009-05517
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Date of Event
    June 4, 2009
    Report Date
    November 1, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE, A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS SENT TO SANMINA FOR ANALYSIS. EVAL RESULTS STATE THAT HEATER PLATE TEMPERATURE WAS NOT WORKING AND THE RF CALIBRATION FAILED. THE MALFUNCTIONS WERE ADDRESSED BY REPLACING THE PELTIER CHIPS AND RECALIBRATING THE RF MODULE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. THE PT RECEIVED 42 MINUTES OF TREATMENT WHEN A HEAT EXCHANGE TEMPERATURE PLATE ERROR MESSAGE WAS DISPLAYED. THE PHYSICIAN FELT THE PT HAD RECEIVED ENOUGH TREATMENT AND COMPLETED THE CASE. FOLLOW UP WITH THE COMPLAINANT REVEALED THE PT IS "FINE" AND THERE WERE NO COMPLICATIONS. NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO. HOWEVER, EVAL OF THE RETURNED CONSOLE REVEALED AN MDR-REPORTABLE MALFUNCTION OF "RF OUTPUT READINGS ARE TOO HIGH". THE MDR IS BASED UPON THE EVAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION SYSTEM, REFURBISHED MEQ BOSTON SCIENTIFIC CORPORATION M006880806R0

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR