IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATOR

Description of Event or Problem

HEALTHCARE PROFESSIONAL REPORTED PATIENT HAVING EXPERIENCED ABDOMINAL DISCOMFORT AND PAIN. PATIENT DESCRIBED THE DISCOMFORT AS A FEELING LIKE THEIR STIMULATION IS ON. PATIENT HAD BEEN IMPLANTED IN 2008 AND THE DEVICE HAS NOT BEEN IN USE FOR SOME TIME. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).