Model Number 1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Seizures (2063); Vomiting (2144)
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Event Date 09/26/2018 |
Event Type
Injury
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Event Description
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It was reported that a patient experienced a moderate increase in seizure frequency related to the implant procedure of the vns device.It was also reported that the day before the increased seizures, the patient experienced severe nausea and vomiting related to the implant procedure.No additional relevant information has been received to date.
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Manufacturer Narrative
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Adverse event or product problem, corrected data: adverse event was inadvertently not checked on the initial mdr.Outcomes attributed to adverse event, corrected data: intervention taken was inadvertently not checked on the initial mdr.Describe event or problem, corrected data: it was inadvertently not reported on the initial mdr that action was taken to correct the nausea and vomiting.
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Event Description
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It was reported that action was taken with regards to the nausea and vomiting.Ondansetron was prescribed/administered to relieve the patient's nausea and vomiting.The nausea and vomiting resolved.No further relevant information has been received to date.
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Manufacturer Narrative
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Type of reportable event, corrected data: the initial mdr should have marked this as a serious injury.
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Manufacturer Narrative
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Describe event or problem, corrected data (initial mdr ) : the increased seizures were not a serious injury per the physician.
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Event Description
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It was reported on the front end by the physician that the increased seizures was not a serious adverse event.
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Search Alerts/Recalls
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