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.Health effect - clinical code :e2302.
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The patient reported that after having her settings increased to 2.75ma she experienced neurological issues.She reported that she felt like she was going to have a stroke, her short term memory was affected, her speech slowed, she would fall down, and she struggled to stand on one foot at a time.She said that her physician lowered her to 2.25ma and those issues resolved.The patient believes that her device is not working properly as she only feels good a few days out of the month and the other days she has increased depression and anxiety.She also reported that sometimes when she turns her neck from left to right she feels a flutter like she can feel her blood moving.No other relevant information has been received to date.
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