Model Number 1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Arrhythmia (1721)
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Event Date 06/10/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient was experiencing tachycardia and the physician was not sure if it was related to vns stimulation.The vns was disabled in order to assess the event.Follow up with the physician's office revealed that the patient has a history of cardiac issues.However, the relation between the vns and the reported tachycardia is still unknown to date as the patient had no events since the vns was programmed off.It was stated that the output current was only around 1.00 ma and the diagnostics were within normal limits.The vns was programmed back on after the disablement period.No additional relevant information has been received to date.
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Event Description
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It was reported that the patient was experiencing bradycardia after the vns was programmed back on.Tablet data was received and review revealed that the device was programmed off with the exception of the magnet mode initially and then, two weeks later, the autostim mode was programmed on to low settings.Review of the data revealed that all results of diagnostic testing were within normal limits.The last autostim mode diagnostics was a few months prior and was within normal limits.
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Event Description
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The patients device is only programmed on for autostim, and is receiving about 50 autostims per day.The autostim sensitivity is 5 and threshold is at 70%.No other relevant information has been received to date.
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Search Alerts/Recalls
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