MAUDE Adverse Event Report: UNKNOWN STEREOTACTIC BODY RADIATION THERAPY; SBRT

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Hypoglycemia (1912); Test Result (2695)

Event Date 02/05/2015

Event Type  Injury  

Event Description

Patient was registered to (b)(6) study on (b)(6) 2014.Sbrt occurred on (b)(6) /2014.Patient received a total of 2800 cgy.On (b)(6) 2015 patient presented via ems to treating hospital's ed with "acute onset, mild constant chest pain radiating to her left arm that woke her from sleep tonight." patient was noted to be hypoglycemic when ems arrived and was treated with oral glucose, on arrival to emergency department blood sugar was 47 and patient was given orange juice resulting in resolution of hypoglycemia.Chest pain also resolved in the emergency department, troponin i and ekg were negative for ischemia at that time but patient admitted to rule out acs and insulin adjustment.Patient was treated with aspirin for chest pain.Patient was discharged later the same day (b)(6) 2015 after remaining asymptomatic and negative second troponin i and ekg.These events were not related to sbrt but are related to patient's underlying medical history.Hypoglycemia - grade 2 at admission (resolved).Chest pain - grade 3 at admission (resolved).History: (b)(6) 2015 - cxr negative for any respiratory or cardiac issues.During the hospital stay patient also experienced hyperglycemia maximal grade 3.Dose, frequency and route used: 1400 cgy x 2 doses.Diagnosis for use: nsclc.

• Brand Name: STEREOTACTIC BODY RADIATION THERAPY
• Type of Device: SBRT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 4516747
• MDR Text Key: 5443811
• Report Number: MW5040732
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/06/2015

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2015
• Patient Sequence Number: 1
• Treatment: NOVOLOG REG INSULIN
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR