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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIATION THEARPY; RADIATION THERAPY
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RADIATION THEARPY; RADIATION THERAPY Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Headache (1880); Nausea (1970); Pain (1994); Vomiting (2144); Weakness (2145); Neck Pain (2433); Confusion/ Disorientation (2553)
Event Date 11/13/2014
Event Type  No Answer Provided  
Event Description
Pt (b)(6) (patient #7) enrolled on a phase i investigation initiated protocol of ipilimumab combined with whole brain radiation therapy or radiosurgery for melanoma patients with brain metastases on and started radiation therapy on (b)(6) 2014.He has past oncologic history of a left paraspinal skin lesion.On (b)(6) 2014, pt.Presented with weakness, increased falls, and confusion since (b)(6) he was at an (b)(6) and was discharged, but the wife did not feel he was 100% ok, so she brought him to (b)(6).He recently finished wbxrt at the (b)(6) and is currently on temodar for treatment.Cth revealed new hemorrhagic mets with some mild compression of the frontal horn of the right lateral ventricle.He complained of headache, leg weakness, nausea, vomiting, neck and back pain.Denied sensory changes or blurry vision or seizure like symptoms.Per treating physician, these conditions are attributable to progressive disease.Research personnel was not aware of this admission until (b)(6) 2014 when patient did not show up for his follow up visit with medical oncologist, therefore, delay in reporting.
 
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Brand Name
RADIATION THEARPY
Type of Device
RADIATION THERAPY
MDR Report Key4277047
MDR Text Key5034410
Report NumberMW5039218
Device Sequence Number1
Product Code IYE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2014
Patient Sequence Number1
Treatment
IPILIMUMAB, DOSE, FREQUENCY & ROUTE USED 10MG/KG,; IV Q3 WEEKS X 4, 2400 CGY
Patient Age39 YR
Patient Weight93
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