BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIART SYSTEM

    MDR report key: 1494574 · Received October 5, 2009

    Report

    Report Number
    3003873069-2009-00004
    Event Type
    Injury
    Date Received
    October 5, 2009
    Date of Event
    June 6, 2009
    Report Date
    October 5, 2009
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    MUJ
    PMA / PMN Number
    K060912
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TOMOTHERAPY REQUESTED COPIES OF THE PATIENT'S PLANS AND SUBSEQUENTLY CONDUCTED A REVIEW OF THE PLANS. THE REVIEW INCLUDED THE PATIENT'S CUMULATIVE AND PLANNED FRACTION DOSE, PRESCRIPTION INFORMATION, TARGET TUMOR AND REGION-AT-RISK CONTOURS, DOSE VOLUME HISTOGRAM AND DOSE IMAGE. IT WAS OBSERVED THAT THE PATIENT'S PLAN WAS CONTOURED SUCH THAT TUMOR TARGETS WERE NEAR (2-4MM) SKIN LEVEL. NO SKIN AVOIDANCE SENSITIVE STRUCTURE (I.E. RIND) WAS CONTOURED. THE DOSE IMAGES INDICATED DOSE AT SKIN LEVEL WAS APPROXIMATELY 4,000-7,000CGY. SKIN INJURY FROM MEGAVOLTAGE RADIOTHERAPY IS AN ESTABLISHED COMPLICATION. FOR 10 X 10CM FIELDS, CLINICAL SKIN INJURY WILL BE EXPECTED TO OCCUR FOR 5% OF PATIENT'S WITHIN 5 YEARS AT 5,500CGY, AND 50% INCIDENCE WITHIN 5 YRS AT 7,000CGY. (LEE N, CHUANG C ET AL. SKIN TOXICITY DUE TO INTENSITY-MODULATED RADIOTHERAPY FOR HEAD-AND-NECK CARCINOMA. INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY 'BIOLOGY' PHYSICS 1 JULY 2002 (VOL. 53, ISSUE 3, PAGES 630-637)). GIVEN THE PRESCRIBED DOSE, TREATMENT VOLUME AND TREATMENT FRACTION SCHEDULE, SEVERE SKIN REACTION FROM RADIOTHERAPY WOULD NOT BE UNEXPECTED. IN ADDITION, TOMOTHERAPY REVIEWED THE EXIT DETECTOR DATA FROM THE PATIENT TREATMENTS, THERE WERE NO SIGNS OF MALFUNCTION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT A PATIENT HAD SEVERE SKIN REACTIONS FROM RADIOTHERAPY AND WAS ADMITTED TO INTENSIVE CARE UNIT. IT WAS OBSERVED THAT THE PATIENT'S PLAN WAS CONTOURED SUCH THAT TUMOR TARGETS WERE NEAR (2-4MM) SKIN LEVEL. NO SKIN AVOIDANCE SENSITIVE STRUCTURE WAS CONTOURED. THE DOSE IMAGES INDICATED DOSE AT SKIN LEVEL WAS APPROXIMATELY 4,000-7,000CGY. THE DOSE WAS ACCURATELY SHOWN IN THE TREATMENT PLANNING SYSTEM AND WAS APPROVED BY THE USER PRIOR TO ADMINISTRATION OF RADIATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIART SYSTEM IYE AND MUJ MUJ TOMOTHERAPY INCORPORATED H-0000-0003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization