This report was due on (b)(6) 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on (b)(6) 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
|
It was reported that bradycardia was observed in a patient who was admitted with psychiatric symptoms coexisting with epilepsy.It was noted that during a 24 hour ecg, a ~40bpm was observed mainly at night.It was noted that the nature of the patient's neck, and effects of the medication for his mental symptoms may have been a factor.The physician was concerned that the lead wrapped around the vagus nerve might be in close contact and interfering with the cardia branches as the patient's neck is bent.The bent neck is noted to be drug-induced dyskinesia for psychiatric reasons.No other relevant information has been received to date.
|