F10 health effect, clinical code: code e2402 utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.) f10 health effect, clinical code: code e2402 utilized; appropriate term ¿muscle spasm¿ is not available.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 :e2402.
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It was reported that patient is experienced painful stimulation in the neck and chest, muscle spasm in the chest, migration of generator that was reported to be due to weight loss, and has been referred for surgery where the generator will be replaced if needed and/or repositioned and the lead will be checked as well.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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