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Model Number 1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Convulsion, Clonic (2222); Status Epilepticus (4408)
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Event Date 05/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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Clinic notes were received reporting that the patient experienced cluster of typical atonic seizures which mom estimated lasted up to 1 hour.Patient also experienced one additional more severe episode.Response was received from the physician that the cause of the cluster atonic seizures and patient's severe episode was due to low battery.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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Manufacturer Narrative
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B5.Describe event; corrected information; initial mdr inadvertently omitted information known prior to submission.B6.Relevant tests/laboratory data; corrected information; initial mdr inadvertently omitted information known prior to submission.D6b.If explanted, give date; corrected information; initial mdr inadvertently omitted information known prior to submission.F10.Health effect - impact code; initial mdr inadvertently omitted information known prior to submission.H6.Adverse event problem, type of investigation; initial mdr inadvertently omitted information known prior to submission.H6.Adverse event problem, investigation findings; initial mdr inadvertently omitted information known prior to submission.H6.Adverse event problem codes, investigation conclusions; initial mdr inadvertently omitted information known prior to submission.
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Event Description
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Implant card was received reporting the that generator was replaced due to a depleted battery.The suspect device has not been received to date.Based on the review of the programming history, diagnostics were seen to be within normal limits and battery level was ok at time of report, therefore the cause of the event is due to patient physiology.
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Search Alerts/Recalls
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