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's device was unable to be interrogated despite troubleshooting by physician.(wand and resetting the programming system, other patient able to be interrogated in same environment, wand batteries changes, multiple interrogation events).The same generator was later unable to be interrogated by a nurse at a later date at a different location than physician.No other relevant information has been received to date.
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