MAUDE Adverse Event Report: SRS RADIATION THERAPY

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Fatigue (1849); Headache (1880); Seizures (2063); Confusion/ Disorientation (2553)

Event Date 11/05/2014

Event Type  Injury  

Event Description

Add'l info received on (b)(4) 2014.Research personal was not aware of this admission until (b)(4) 2014 upon reviewing his medical record for today's oncologist visit.Pt glm (#16) is enrolled on a phase i study of ipilimumab combined with whole brain radiation therapy or radiosurgery for melanoma pts with brain metastases and started radiation therapy on (b)(6) 2014, 20 gy to left parietal lesion and 22 gy to left cerebella lesion.He has past hx of metastatic melanoma, skin melanoma to the back removed with positive lymph nodes.On (b)(6) 2014, pt seen by local onc with trouble of right leg, blood clot discovered and treated with lovenox.On (b)(6) 20114, pt presented to local ed with difficulty breathing and chest pain.Pt family called np on call to notify pt complaining of difficulty breathing and extreme chest pain.He was recently dx with dvt.Family informed to immediately proceed to local ed.Pt admitted on (b)(6) 2014 with dx of pulmonary embolism, pt treated and discharged on (b)(6) 2014.Per treating physician, this condition is possibly attributed to ipilimumab, possibly attributed to melanoma, not attributed to radiation therapy.Pt scheduled to see osu medonc for f/u visit (b)(6) 2014.On (b)(6) 2014, pt was unresponsive on arrival to clinic emergency squad was called and pt was sent to ed.Pt was hospitalized later due to grade 3 syncope.Per treating physician, at this time possible attribution to withdrawal from narcotics.This condition is not attributed to ipilimumab, not attributed to melanoma, not attributed to radiation therapy.Per treating physician - his work up is underway.Based on the findings our original attribution may change.Sae will be updated as more info becomes available.Therapy dates: 10 mg/kg, iv q3 wks x 4 - (b)(6) 2014; 20 gy and 22 gy - (b)(6) 2014.

Event Description

Pt (b)(6) enrolled in a phase i investigator initiated protocol of ipilimumab combined with whole brain radiation therapy or radiosurgery for melanoma therapy on (b)(6) 2014.He was diagnosed with melanoma originating on his back metastatic to lymph nodes, duodenum (b)(6) 2014.On (b)(6) 2014 for the left parietal lesion a total of 1 shot with the 8-16 mm collimator, a dose of 20 gy was prescribed to the 50% isodose line.For the left cerebella lesion, a total of 1 shot with the 4-8 mm collimators.A dose of 22 gy was prescribed to the 50% isodose line.Pt is a (b)(6) male with cerebral metastases secondary to a melanoma primary admit with new onset seizures.Still very fatigued but better than yesterday morning.Still has some confusion.Complaints of headache distinct from chronic headaches.Otherwise nothing new.On examination he looks very tired; however, he would answer questions correctly and was fully oriented.Was not in distress.No lateralizing weakness or sensory changes.No ataxia.Attributions not available currently, report will be updated as more info becomes available.Good visual attention when prompted.As he looked very tired did not walk him.No abnormal movements noted.Reviewed mri of brain.There is some more edema around previously noted lesion.Minor increase.Contrast was not administered as he was unable to lie still.I suspect the lesion is slightly larger.No new hemorrhage.Plan: for seizures, continue keppra.Discussed how he will need this agent long term.Reviewed side effect profile.No evidence of recurrent seizures.He is gradually improving from post-ictal state.Of note, he was very tired prior to seizure.No change in dose or schedule.For headache.Prior headache is doing better since being on gabapentin.In fact, he is not having it right now; however, since increasing dose (and starting gabapentin in general) he may have more fatigue.Despite fact it may be working may have to consider alternative agent.For now will not change.For corticosteroids, will determine home dosage.He is not on 16 mg per day which i suspect is much higher than home dosage.Changes on mri are associated with more edema.Although not big change proximity to eloquent brain may be factor.Also, changes may be treatment related.As such will continue higher dosage of dexamethasone but may reduce dose to 12 mg per day.Vitamin d and calcium.For disposition, he is gradually improving since admission.He was very fatigued prior to event.He is working with pt/ot.Will reassess his condition later this afternoon and may consider discharge if doing ok.Ipilimumab 10 mg/kg, iv q3 weeks x4.300 cgy.

• Brand Name: SRS RADIATION THERAPY
• Type of Device: RADIATION THERAPY
• MDR Report Key: 4253516
• MDR Text Key: 5214042
• Report Number: MW5039039
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

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 Received: 11/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 69