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.
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It was reported that patient has been having trouble with her device for the past six months.Patient has had muscle spasms from her head to the bottom of her abdomen, and shocking down the left side of her chest.Patient notes that ever since she has had the device, it has been painful yet tolerable once her settings were managed.Over the past 6 months the muscle spasms and shocking are constant, but the stimulation makes them symptoms worse.The pain is so bad it makes her grunt.Patient is also experiencing fatigue.Psychiatrist lowered settings but that has not helped with any symptoms.Patient further reports she had a chest x-ray and and ct due to the pain.Additional information was received that patient improved on discontinuation of vns stimulation but still experiences abdominal and some chest muscle spasms.Patient also reports spasm or shocks and responses also happen with increased anxiety.The physician may adjust anxiety medicine and or taper off her risperidore.They were able to discontinue output current successfully and patient reacted well.No other relevant information has been received to date.
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