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 livanovas 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.
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Additional information was received by the physician that the device was disabled due to the patient unable to tolerate their previous settings in (b)(6) 2023.The patient was then experiencing an increase in seizures above pre-vns baseline levels and was noted to be due to the lack of vns stimulation in (b)(6) 2023, as device had been intentionally programmed off.It was also noted that the expressed suicidal ideation with intentions of taking other with him was due to him feeling miserable.Specifically, he was experiencing an increase in seizures from a lack of vns stimulation.Therefore, the cause of the suicidal and homicidal ideations can be concluded to be lack of vns stimulation.The device was noted to be re-enabled in (b)(6) 2023 and that the patient is tolerating these programmed settings.Along with this, the battery status was found at end of service and patient was referred for generator replacement.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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