MAUDE Adverse Event Report: SBRT; RADIATION THERAPY

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Unspecified Infection (1930); Sweating (2444)

Event Date 04/13/2015

Event Type  Injury  

Event Description

(b)(6) phase ii randomized study of 2 stereotactic body radiation therapy (sbrt) regimens for medically inoperable pts with node negative, peripheral non-small cell lung cancer.Lung infection, rml, grade 3, r/t disease, copd, unrelated to sbrt.Pt was seen by pulmonologist on (b)(6) 2015 and started on augmentin po for elevated temps/nightsweats.Pt went in to local ed on (b)(6) 2015 for continued increased temps to 104.Pt admitted, started on iv antibiotics vancomycin and zooyn.Cultures drawn negative so far.Pt received sbrt total 40 gy so far, 20 gy on (b)(6) 2015 and 20 gy on (b)(6) 2015.Pt missed his final treatment as of (b)(6) 2015 due to hospitalization.Pt will be rescheduled asap.(b)(6).

• Brand Name: SBRT
• Type of Device: RADIATION THERAPY
• MDR Report Key: 4706918
• MDR Text Key: 5669363
• Report Number: MW5042126
• 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: 04/14/2015

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: 04/17/2015
• Patient Sequence Number: 1
• Treatment: FORMOTEROL (FORADIL AEROLIZER) 12 MCG INHALATION; OXYGEN-AIR DELIVERY SYSTEMS MISC, USE 2 L/MIN IN; AMOXICILLIN-CLAVULANIC ACID B75-125 MG/TABLET,; CIPROFLOXACIN HCL 500 MG/TABLET,; TAKE ONE BY MOUTH BID; HOURS AS NEEDED FOR WHEEZING/SHORTNESS OF BREATH; ALBUTEROL HFA (VENTOLIN HFA) 90 MCG/ACTUATION; TAKE 220 MG BY MOUTH ONCE DAILY; FLUTICASONE (FLONASE) 50 MCG/ACTUATION NASAL SPRAY; 2 PUFFS AS INSTRUCTED BID; HAPROXEN SODIUM (ALEVE) 220 MG TABLET,; INHALER, INHALE 2 PUFFS AS INSTRUCTED EVERY 4; USE ONE SPRAY IN EACH NOSTRIL TWICE DAILY; CAPSULE, INHALE 1 CAPSULE ONCE DAILY; BECLOMETHASONE (QVAR) 80 MCG/ACTUATION INHALER; THE NOSE DAILY AT BEDTIME AND DURING DAY AS WELL; TAKE ONE BY MOUTH BID X7 DAYS
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 73