BEUDAMED
    FDA Adverse Event Death Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 4245021 · Received November 6, 2014

    Report

    Report Number
    2915056-2014-00015
    Event Type
    Death
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDI-PHYSICS, INC., DBA GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT OF TWO CASES DIED OF PROGRESSIVE SECONDARY CANCER AFTER PROSTATE BRACHYTHERAPY. NO INFORMATION IS GIVEN REGARDING THE ADDITION OF EXTERNAL BEAM RADIOTHERAPY TO BRACHYTHERAPY. THE FORMER HAS BEEN ASSOCIATED WITH SECONDARY BLADDER CANCER. HOWEVER, A RECENT REVIEW BY MURRAY ET AL STATED "THE INCREASED RISK OF BLADDER CANCER FREQUENTLY APPEARS TO BEGIN WITHIN 5 YEARS OF FOLLOW-UP INT HE ABOVE STUDIES AND SO RADIATION IS NOT THE LIKELY CAUSE OF THESE EARLY BLADDER TUMORS. SURVEILLANCE BIAS, AS A RESULT OF REGULAR ONCOLOGICAL OR UROLOGICAL FOLLOW-UP MAY PLAY A PART IN THIS, WHILE THE IMPACT OF SMOKING MAY ALSO BE INVOLVED IN EARLY (I.E. LESS THAN 5 YEARS FROM RT) AND LATE (I.E. BEYOND 5 YEARS OF RT) BLADDER CANCER DEVELOPMENT. BEYOND 5 YEARS THE RISK OF BLADDER CANCER APPEARS TO INCREASE FURTHER, AND RADIATION MAY BE ATTRIBUTED TO THIS ALTHOUGH THE FACTORS MENTIONED ABOVE SHOULD ALSO BE CONSIDERED. BRACHYTHERAPY ALONE HAS NOT BEEN SHOWN TO INCREASE THE RISK SECONDARY OF BLADDER CANCER. IN A RECENT STUDY BY HAMILTON ET AL DE INCIDENCE BLADDER CANCER AFTER BRACHYTHERAPY ALONE WAS NOT INCREASED WHEN COMPARED WITH BLADDER CANCER SUBSEQUENT TO RADICAL PROSTATECTOMY. INCIDENCE OF SECOND PRIMARY BLADDER CANCER WAS LINKED TO SMOKING HISTORY AND AGE.

    Description of Event or Problem · 1

    REPORT #2915056 -2014-00015 IS A LITERATURE REPORT FROM (B)(6) WHO EXPERIENCED SECONDARY BLADDER CANCER STAGE IV WITH PARA-AORTIC LYMPH NODE METASTASES AFTER ADMINISTRATION OF IODINE (I-125) SEEDS FOR BRACHYTHERAPY FOR THE INDICATION OF PROSTATE CANCER. CONCURRENT MEDICAL CONDITIONS/PAST MEDICAL HISTORY INCLUDED PROSTATE CANCER. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED AN IMPLANT ADMINISTRATION OF IODINE (I-125) SEEDS FOR THE PROCEDURE. THE PATIENT, WITH A PREOPERATIVE PSA 7.2 NG/ML AND PREOPERATIVE DIAGNOSIS (B)(4) (GS6), UNDERWENT BRACHYTHERAPY. THERE WAS GROSS HEMATURIA IN TWO YEARS AND NINE MONTHS AFTER BRACHYTHERAPY AND THE PATIENT VISITED THE HOSPITAL. HE WAS DIAGNOSED WITH (SQUAMOUS CELL CARCINOMA) STAGE IV BLADDER CANCER TO DOUBT PARA-AORTIC LYMPH NODE METASTASIS. HE UNDERWENT RADIATION AND CHEMOTHERAPY. THE PATIENT DIED THREE YEARS AND ELEVEN MONTHS AFTER BRACHYTHERAPY. ENOKIDA HIDEKI ET AL; REPORT OF TWO CASES DIED OF PROGRESSIVE SECONDARY CANCER AFTER PROSTATE BRACHYTHERAPY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714370 IODINE (I-125) SEEDS IODINE (I-125) SEEDS KXK MEDI-PHYSICS, INC., DBA GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death