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Author Topic: Tachycardia/Hypertension  (Read 94318 times)
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dennis100
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« Reply #240 on: July 06, 2019, 12:18:19 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Possible tachycardia was noted in the patient's chart. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8730515
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dennis100
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« Reply #241 on: August 10, 2019, 03:43:29 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/15/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced changes in hear rate related to the vns. It was reported that the patient experienced tachycardia, their heart rate prior to the event was reportedly 70 bpm and the heart rate during the event was approximately 200 bpm. It was reported that the patient experienced palpitations and that there were no traumatic events or triggers prior to the arrhythmia. The event did not follow a medication change, device diagnostics test, a settings change or with the on time of the vns. The neurologist assessed that the tachycardia was not related to vns therapy stimulation; however, it was indicated that the vns exacerbated or co-currently contributed to the arrhythmia. The patient's generator was disabled due to the tachycardia experienced but the neurologist reported this was not performed to preclude a serious injury. The patient's neurologist reported that the patient had a prior history of cardiac events including cardiac dysrhythmia and bradycardia. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8780203
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dennis100
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« Reply #242 on: August 10, 2019, 03:44:17 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/10/2019
Event Type  Injury   
Event Description
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8763005
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