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Model Number 8103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Mental, Emotional or Behavioural Problem (4430)
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Event Date 11/07/2021 |
Event Type
Injury
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Event Description
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It was reported for a clinical study patient that they are experiencing increased cognitive impairment.It was noted that this is a serve adverse event (sae) and is possibly related to vns stimulation and the vns device.The outcome is unknown.Information was received regarding the patients reported increased cognitive impairment.This event was noted to meet the sae criteria, the patient experienced hospitalization.It was stated that the event is possibly related to vns stimulation, possibly related to device, possibly related to concomitant medication, possibly related to other medical condition, and possibly related to primary condition.It was noted that action was taken.No additional relevant information has been received to date.
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Event Description
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It was reported for a clinical study patient that they are experiencing increased cognitive impairment.It was noted that this is a serve adverse event (sae) and is possibly related to vns stimulation and the vns device.The outcome is unknown.Information was received regarding the patients reported increased cognitive impairment.This event was noted to meet the sae criteria, the patient experienced hospitalization.It was stated that the event is possibly related to vns stimulation, possibly related to device, possibly related to concomitant medication, possibly related to other medical condition, and possibly related to primary condition.It was noted that action was taken.No additional relevant information has been received to date.
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Event Description
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Additional information was received that event began on (b)(6) 2021 and resolved on (b)(6) 2021.No additional relevant information has been received to date.
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Event Description
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Modified information was received reporting that adverse event was assessed as no longer related to the vns stimulation, device or procedure.
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Search Alerts/Recalls
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