inforMED
InjuryIWB

GAMMA KNIFE RADIOSURGERY

Received Jul 29, 2019 · Event occurred Jun 27, 2019

Report MW5088510 · MDR key 8842898

Device

Generic name

System, Radiation Therapy, Radionuclide

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

58 YR

  • Seizures
  • Seizures

Narrative

Description of Event or Problem

PATIENT FOUND TO HAVE SEIZURE LIKE ACTIVITY SUCH AS FOAMING AT THE MOUTH AND SHAKING BY FAMILY ON 06/27/2019 AND WAS BROUGHT TO LOCAL EMERGENCY DEPARTMENT. EEG COMPLETED DURING HOSPITALIZATION AND WAS NEGATIVE FOR SEIZURE ACTIVITY. NO FURTHER SEIZURE LIKE ACTIVITY SINCE THAT EVENT. NCT # (B)(4). CTCAE V4 GRADE Z SEIZURE UNLIKELY RELATED. DATES OF USE: (B)(6) 2019. DIAGNOSIS OF REASON FOR USE: BRAIN METASTASIS.