BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 2091861 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01756
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM KIT WAS SUCCESSFULLY USED DURING A PROCEDURE AS A PART OF THE (B)(4) STUDY (B)(4) TO TREAT BENIGN PROSTATIC HYPERPLASIA (BPH) ON (B)(6), 2008. DURING A POSTOPERATIVE VISIT ON (B)(6), 2011, IT WAS REPORTED THE SUBJECT MUST STRAIN IN ORDER TO VOID, BEGAN TO EXPERIENCE NOCTURIA AND BEGAN TO EXPERIENCE BLADDER SPASMS WHEN THE SUBJECT HAD A FULL BLADDER PRIOR TO URINATION. ALL THE SYMPTOMS REQUIRED TREATMENT, HOWEVER SPECIFIC TREATMENT IS UNKNOWN. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE COMPLAINANT REVEALED NO MEDICATION TREATMENT WAS PRESCRIBED FOR THE SYMPTOMS OF BLADDER SPASMS, NOCTURIA AND STRAINING TO VOID WHEN REPORTED ON (B)(6) 2011, SUBSEQUENTLY, THE PATIENT WAS SET UP FOR SURGERY, A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) ON (B)(6) 2011. IT WAS ALSO REPORTED THESE SYMPTOMS WERE NOT PRESENT AT THE TIME OF THE PROLIEVE TREATMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY MEQ BOSTON SCIENTIFIC - MARLBOROUGH M0068808022 000060528

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention