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 after implantation and having the device programmed on, the patient started feeling occasions of palpitations in which the settings were noted to be lowered and eventually disabled for a couple months.Upon re-enabling the device, it was noted that the patient was experiencing an increase in seizures due to feeling the stimulation extending to her arm/elbow.Device settings was noted to be decreased no other relevant information has been received to date.
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