Model Number 105 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Seizures (2063)
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Event Date 01/13/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced an increase in seizure frequency.The patient's physician reported that the vns magnet did not suppress one of the patient's seizures, due to the generator battery "dimming" likely referring to the generator battery being lower.The battery life was provided as having 25-50% battery life remaining.The patient was referred for generator replacement.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.
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Event Description
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The explanted generator was received by the manufacturer and product analysis was performed.The generator was monitored for 24 hours in a stimulated body temperature environment and provided the intended output current for the entirety of the monitoring period.A comprehensive electrical evaluation showed that the device performed according to functional specifications.Magnet activations performed during output monitoring demonstrated appropriate magnet output.There were no performance or any other type of adverse conditions found with the pulse generator.No further relevant information has been received to date.
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Manufacturer Narrative
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Analysis of the suspect device is underway.
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Event Description
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The patient's generator was prophylactically replaced.The generator was received by the manufacturer for product analysis; however, product analysis has not been completed to date.No further relevant information has been received to date.
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Event Description
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The neurologist reported that the cause of the patient's increase in seizure frequency was related to the low battery of the vns generator, despite the battery indictor showing 25-50% remaining.It was also reported that the increased seizure rate was not worse than pre-vns seizure rate baseline and that there were no known external factors contributing to the increased seizures.The physician indicated that the causation of the magnet not aborting the seizure was initially believed to be swipe technique but was since determined to likely be related to low battery of the generator.No further relevant information has been received to date.
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Search Alerts/Recalls
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