A report was received that during a trial lead implant procedure, the patient experienced a dural tear or nerve graze.Nine days after the procedure, the patient experienced a right inferior cerebellar stroke.The trial leads were removed during the normal scheduled time.The patient underwent rehabilitation from (b)(6) 2017.He is showing improvement with his speech, closing his right eye, and walking.However, his balance is still affected as he is unsteady on his feet.Since the implant, the patient cannot feel temperature differences in his left arm and still feels pins and needles.The physician stated the event may be related to the procedure and not the device.
|