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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Data was received and reviewed for the patient's generator.The battery voltage dropped to ifi (intensive follow-up indicator) remaining shortly after the removal of the 0.5 v offset due to the battery reaching the 7.5% threshold.No rebound has been observed at this time.Based on the charge consumption, it is not expected that the generator would be at ifi battery remaining.This is not indicative of a device failure but a normal design of the device.The impedance history was reviewed no issues were seen.No other anomalies were noted in the decoder review.Based on the data review, this appears to be a case of the bol battery impedance causing the generator to display battery at ifi when in reality the generator battery voltage is not low.
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