Model Number 102 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Liver Damage/Dysfunction (1954)
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Event Date 04/30/2012 |
Event Type
Death
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Event Description
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It was reported that the vns study patient passed away on (b)(6) 2012.The national death index from the cdc website listed the patient's cause of death as liver disease.The relationship of the death to vns is unknown.No further information relevant to the patient's death has been received to date.Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.
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Manufacturer Narrative
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Describe event or problem, corrected data: the initial report should not have reported this death as there was no suspected relationship between the cause of death and vns.The initial report should not have reported this death as there was no suspected relationship between the cause of death and vns.
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Event Description
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Based on the cause of death, there was no suspected relationship between the cause of death and vns.It was reported by the patient's treating neurologist that the patient's death was unrelated to vns.
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Search Alerts/Recalls
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