It was reported via clinic notes that the patient's "seizures were under good control until (b)(6) 2011 when she started noticing spells involving confustion and staring.
" the patient's amplitude setting was increased and the patient will be referred for prophylactic generator replacement.
Attempts for further information have been unsuccessful to date.
Event Description
Additional information was received indicating that the patient's generator was replaced.
Product has been requested, but has not been returned to the manufacturer to date.