Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Depression (2361)
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Event Date 06/13/2022 |
Event Type
Injury
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Event Description
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It was reported that patient's vns has worked for both epilepsy and depression but has noticed a little increase in depressive symptoms but nothing severe or awful.Physician reported it may be related to the vns or it could be altogether separate.They will see after her generator is replaced.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.
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Event Description
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Provider later reported that the cause of increase in seizures is external factors, not vns.The increased depression is also above pre-vns baseline levels.
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Event Description
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It was later reported that patient had a prophylactic generator replacement.Product return is not necessary as it is already known the increased depression is not related to vns therapy, therefore analysis will not add any value to the investigation.
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Manufacturer Narrative
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H3.Code 81 - device evaluation is not necessary because the reported event has been determined as not related to vns therapy.H3 other text: 81.
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Search Alerts/Recalls
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