During a review of the programming history database, it was determined that the generator had two events of disablements due to error code 6 (reset code).Error code 6 involves unexpected device reboots resulting in disablement of therapy.The device was noted to be in a stimulation stopped state in 2 instances, which are not expected events; this is when the device was noted to unexpectedly reboot.Internal data from the generator was received and reviewed.The device history records of the generator was reviewed.The generator passed final functional tests prior to distribution.No other relevant information has been received to date.
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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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