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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARIAN TRUEBEAM RADIOTHERAPY SYSTEM

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VARIAN TRUEBEAM RADIOTHERAPY SYSTEM Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Burn(s) (1757); Diarrhea (1811); Fatigue (1849); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Swelling (2091); Blurred Vision (2137); Weakness (2145); Burning Sensation (2146); Hot Flashes/Flushes (2153); Tingling (2171); Chills (2191); Dizziness (2194); Urinary Frequency (2275); Depression (2361); Irritability (2421); Sweating (2444); Confusion/ Disorientation (2553)
Event Date 01/25/2016
Event Type  Injury  
Event Description
Eligard injection was given (b)(6) 2015 and some side effects began 3 days later.I was injected with eligard although my cancer prostate was confined to the prostate, less than 3/4 of the prostate was affected and all evidence pointed to the cancer being a slow growing cancer.There was no evidence the cancer had spread outside the prostate.Beginning, (b)(6) 2016 received radiation therapy (radiotherapy) at (b)(6) healthcare, in (b)(6).There were 43 treatments scheduled monday through friday of each week, and a meeting each week with the radiation oncologist (dr.(b)(6)).After radiation therapy sessions, i complained to the radiation oncologist that i was having diarrhea, his reply use imodium d.The diarrhea continued to get worse and became very chronic and the increase in urgency became worse.Yet the radiation oncologist insisted use imodium d.Also, my blood pressure has increased from a normal 121 mm/hg systolic, 70 mm/hg diastolic and a pulse of 71 (controlled by use of blood pressure medications) to 185 mm/hg systolic, 86 mm/hg diastolic and a pulse of 97.My blood glucose level has increased from a normal reading under 120 milligrams per deciliter to near 180 mg/dl.The hot flashes (a sudden wave intense body heat), sweating, or clamminess (over 2 years after eligard injection (6-month) and radiation therapy) these hot flashes / "night sweats" continue to plague me.They can occur at any time however they are more prevalent between the hours 22:00 to 03:30 (10 pm to 3:30 am) often occurring at intervals of 15 to 25 minutes apart.They seem more severe and are much more bothersome.Chills, fever and headache usually followed these hot flashes.Mostly these came around 04:00 (4 am) and it was almost impossible to get back to sleep.Recently (since (b)(6) 2017) this has subsided to maybe once or twice weekly.Because of the serious nature of diarrhea, blood pressure increase, blood glucose increase, aggravation of hashimoto's and in ability to get in rest because of the hot flashes/ "night sweats", it was necessary for me to leave my job in (b)(6).Radiation seemed to aggravate the swelling of the feet, ankles, or lower legs that began near the (b)(6) 2015 and to this date, my feet and ankles continue to swell.The swelling was accompanied by an aching pain, burning, and tingling in my feet.The aching pain, burning, and tingling are still occurring.It is so severe at times that i can not tell if it was further aggravated by radiation therapy.A general overall weakness took over and i felt at times unable to move as the weakness in my legs and pain in leg bones and joints were so devastating.I can not say that radiation therapy is not a contributor to this problem.Urination became more frequently.Radiation therapy has definitely been a contributor to this problem.Dizziness and confusion began, also i noticed a blurring in my vision and overall changes to my vision as i could not see as well.The blurring was especially bad when attempting to read or use the computer.It made working much more difficult.These things together were of such an impact, and the confusion made me extremely tired and i became depressed.Depression, confusion and a general feeling of discomfort and uneasiness of were responsible as i lost control of my emotions and i began to have frequent mood changes.Along with the dizziness and confusion was also another disturbing fact, difficulty with my memory especially short term memory.Decrease ability and desire for sexual intimacy, as it was more pronounced with the size of my testicles decreased which served to further depression.Radiation has been a contributor to the items 8, 9, 10, and 11 and has caused the foreskin shrink.See relevant tests.The overall response of the radiation oncologist has been oh there is no side effect to radiation therapy.How can you explain the following conditions if radiation therapy is not to blame? the radiation was to be directed to the prostate.Radiation burns to the colon from the rectum up the descending colon to and including the transverse colon, the duodenum, the jejunum and the ileum.In addition my pancreas was badly damaged by radiation therapy and no longer is producing digestive enzymes necessary for normal food digestive system.These burns were substantiated by a colonoscopy on (b)(6) 2016 and later by pictures of the inflammation on the colon during surgery (b)(6) 2017.However, according to dr.(b)(6), there is no side effects to radiation therapy.Then he must have not known how to perform a simple alignment to direct the radiation to the prostate.He did not take normal precautions to insure radiation would be directed at the prostate along and prevents any abdominal radiation from occurring.The machine used to administer the radiation therapy was the varian truebeam radiotherapy system.The system malfunctioned three times during the times of my treatment, forcing a rescheduling of treatment times.There are a number of other side effects that i have not listed.
 
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Brand Name
TRUEBEAM RADIOTHERAPY SYSTEM
Type of Device
TRUEBEAM RADIOTHERAPY SYSTEM
Manufacturer (Section D)
VARIAN
MDR Report Key7199870
MDR Text Key97705615
Report NumberMW5074609
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Weight104
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