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Author Topic: Palpitations  (Read 3563 times)
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dennis100
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« Reply #30 on: May 11, 2019, 04:02:04 AM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a neurologist reported that he visibly could see and feel stimulation on a patient¿s neck. The neck was seen to be vibrating. Diagnostics were ok. The neck would vibrate a couple times during the day, and did not occur with every stimulation. The patient had noted it to be annoying and uncomfortable. The physician was not sure if it was muscle spasms. Additional information was received that the patient had an allergic reaction to a medication in december and was intubated for four days. Since that time she has had painful stimulation that is palpable through the skin of her neck. She also reports shortness of breath. She indicated that the settings were re-adjusted 8 weeks ago, but she is continuing to experience uncomfortable stimulations, stimulations that are palpable through the skin, shortness of breath, and palpitations. Clinic notes were received that the is referred for lead replacement. Notes state patient is still having 30 or more painful stimulations a day and they have discussed replacing leads. Notes state that they need to check the lead as it hasn¿t been the same since she was intubated. Regarding shortness of breath notes state doing well currently. Regarding dysphagia notes indicated stable related to vns and post intubation, discussed with her local ent and will refer for lead replacement. Complains of hoarseness due to vns. Cardiology notes state the patient denies chest pain, shortness of breath and palpitations. Notes again mention the palpable muscle spasm over the left anterior neck during stimulation. Surgery referral for the lead revision is to diagnose and or rule out vns as the cause. While surgery is likely it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8552815
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dennis100
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« Reply #31 on: May 11, 2019, 04:02:54 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2017
Event Type  Injury   
Event Description
It was reported that the patient experiences pain at the generator site when lying on left side, migration of the device and intermittent arrhythmia with stimulation. Patient mentioned that she hasn't ever been able to sleep on her left side because it causes some discomfort where the generator is located. It was described that it felt like her heart was "beating against the generator" even though she knew they weren't physically touching. She also mentioned that for about two weeks, she has felt like her heart was racing and pounding, which was intermittent and not with every stimulation. Then one day patient felt that her heart racing was more consistent with what felt like every stimulation on-time. Patient was told to go to er and the er physician instructed her to tape the magnet over her device to stop the stimulation, which appeared to resolve the issue. While in the er, it was confirmed that her heart rate (hr) was rising to about 105-110 beats per minute (bpm), but when the magnet was taped over, her hr dropped and remained about 80bpm. The patient then saw her neurologist and had the device turned off. The patient confirmed that diagnostics were performed as the physician told her it was functioning properly. It was then mentioned that she can move the generator around with her hand from her armpit to chest, which has been like this for some time. Per a nurse at the neurologist office, the first time patient reported about the heart beating against the device was on (b)(6) 2017. No known interventions were taken for the chest pain or migration and no known trauma or manipulation were involved. The patient underwent generator replacement and the explanted generator was discarded.
 
Manufacturer Narrative
If explanted, give date (mo/day/yr), corrected data: (b)(6) 2017. Initial mdr inadvertently listed the explant date as (b)(6) 2017 instead of (b)(6) 2017.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6499756
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dennis100
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« Reply #32 on: May 11, 2019, 04:03:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/28/2019
Event Type  Injury   
Event Description
Patient¿s mother reported that the patient was experiencing heart palpitations and that the patient's cardiologist and neurologist agreed to proceed with device removal. It was noted that the patient did not experience heart issues prior to vns implant. It was noted that device settings were being titrated down in preparation for device explant. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8549301
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