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 the patient would be undergoing a colonoscopy due to a prolapse.Per the physician, they do not believe the prolapse is related to the vns, though were questioning if vns could be a possible cause.Clinic notes were later received reporting the patient has a prolapse from their ostomy and was also experiencing coughing.Per the patient's family, the coughing had been around for years, but did worsen after the last vns replacement; family also believed the coughing was related to allergies.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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