Pages: 1 ... 10 11 [12]   Go Down
Print
Author Topic: Bradycardia/Hypotension  (Read 162448 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #330 on: March 09, 2019, 03:58:51 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2005
Event Type  Injury   
Event Description
Clinic notes indicated that the patient experienced bradycardia with high vns stimulation on their current m105 generator (captured in mfr. Report # 1644487-2014-02030). It was also implied that it may have occurred with their initial generator (as captured in the current report). No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8341579
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #331 on: April 06, 2019, 02:56:47 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2019
Event Type  Injury   
Event Description
It was reported that a patient had bradycardia when their device was titrated from 1. 0ma to 1. 25ma output current. The bradycardia stopped when the vns was disabled. No additional information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8383941
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #332 on: April 07, 2019, 04:17:35 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced very low heart rates (reportedly in the 20s) to very high heart rates (reportedly in the 200s). The patient reportedly taped the magnet over the generator to inhibit stimulation which resolved the event until the magnet fell off. After this, the patient experienced a low heart rate and felt as if he would pass out. The neurologist reported system diagnostics results were within normal limits and the patient was at moderate settings. The physician was concerned that the lead was ¿tethered incorrectly¿ and requested x-rays be performed. The patient was referred for surgery to inspect the leaf. Ap neck and lateral chest x-rays of the patient were reviewed. The scope of the images did not include the generator and therefore the placement of the generator, the intactness of the feedthru wires, and complete lead pin insertion could not be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. A strain relief bend is present per labeling but no strain relief loop is present. Two tie downs are present with the initial tie down securing the first relief bend, and the second tie down securing a second relief bend. It could not be assessed if the lead was routed behind the generator due to the scope of the image. No sharp angles were identified in the visible portions of the lead. No gross discontinuities were identified in the visible portions of the lead. Additionally, the electrodes appeared to be placed normally on the patient¿s nerve. No obvious cause of the patient¿s heart fluctuations could be identified from the available images. A review of the available images did not reveal any anomalies that indicated device malfunction. Follow up with the patient's neurosurgeon determined that the patient had also passed out multiple times due to the low heart rate. Additionally, the patient's vns was disabled due to the arrhythmia after which the heart issues resolved. The physician also reported that there was no known changes in the patient's vns therapy prior to the heart issues which would have contributed. The patient has been referred to a local electro physiologist for additional evaluation. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8443672
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #333 on: April 07, 2019, 04:18:22 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
The physician reported that the patient's heart rate intermittently dropped to the "30s" (assumed to mean 30 beats per second) during a video eeg. It was reported that the patient's heart rate resolved after the vns generator was turned off. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8410092
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #334 on: May 01, 2019, 01:32:59 AM »

Model Number 102R
Event Date 11/16/2012
Event Type  Injury   
Event Description
Additional information was received from the patient's treating physician. The patient event was classified as bradycardia with asystole. Patient experienced bradycardia and asystole; heart rate prior to event: 72/min,heart rate during event: 35/min. Event not occur intra-operative. Arrhythmia event date (b)(6) 2012 and repeatedly during a period of approx. 1 month before symptoms suggesting arrhythmia: vertigo(presyncopal). No traumatic events prior to arrhythmia, and no triggers the patient is taking medication:valproate 6000 - 150 - 900mg, levetiracetam 2000 - 1000 - 1000mg, lacosamide 200 - 0 - 150mg. Event did not follow a change in medication. Arrhythmia does not correlate with on time. Event did not occur during device diagnostics (not performed), or change in settings. Diagnostic studies to diagnose arrhythmia: ecg. The patient's treating physician believes the event is related to vns. The event does not occur without the stimulation being present. Their device was disabled. The patient wast hospitalized and in intensive care and cardiology department when this event occurred. Since their device has been disabled their arrhythmia has not re-occurred. Four x-ray images (2 chest ap, 1 neck ap, 1 neck lateral) were received for review. The generator was visualized in the left upper chest, the front of the generator is facing forward. The filter feed-through wires appear to be intact and the lead connector pins are fully inserted into the generator connector block. Only a limited section of the lead is visible and could be assessed, as some is located behind the generator. The electrodes, strain relief bend and loop are outside the view, therefore it cannot be ascertained if these are present or if the electrodes are correctly aligned on the vagus nerve. No anomalies were noted.
 
Event Description
It is unknown if the device will be programmed on again.
 
Event Description
A vns treating physician in (b)(6) reported to our country manager that they had a patient who was approximately (b)(6), female with epilepsy. It was reported that the patient had fallen recently and landed on back/head. The patient was now having cardiac rhythm disturbances, connected to vns stimulation on time period. Their cardiologist has done check and sees connection. The issue started two months ago. X-rays will be planned/ordered, possibly electrographic analysis to see if lead ok. Generator turned off. Device has been disabled for fear that a further cardiac risks could develop. The patient's heartbeat of patient now slower, with vns on period. Checks done by cardiologist: no cardiac disease. Output current 2 ma, frequency 30 hz, pulse width 500 s, duration 30 s, interval 5 min. Investigation is underway. At this time no further information has been attained.
 
Event Description
Reporter indicated the patient had the vns generator and lead explanted on (b)(6) 2013 and no new devices were implanted. The explanted devices were returned to the manufacturer on (b)(6) 2013, with paperwork indicating the devices were explanted due to "cardiac arrhythmia". Product analysis of the generator and lead is pending.
 
Event Description
Product analysis of the vns generator and lead was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. The abraded openings and slice and incision marks found on the lead outer silicone tubing most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the inner silicone tubes. Abraded openings were observed on the outer and inner silicone tubes. With the exception of abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, only abraded openings were observed. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Additional follow up with the physician revealed that additional vns programming history for the patient was not available, and that the patient did have trauma in the past, but the trauma was not specified.
 
Manufacturer Narrative
Product serial number: corrected data updated to correct serial number. Manufacturer reviewed x-rays of implanted device. X-rays reviewed of implanted device and no anomalies noted.
 
Manufacturer Narrative
Device failure is possible in the lead portion not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870936
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #335 on: May 10, 2019, 02:39:23 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
Article titled "a rasmussen encephalitis, autoimmune encephalitis, and mitochondrial disease mimicker: expanding the dnm1l-associated intractable epilepsy and encephalopathy phenotype" was reviewed. Within this article, it was reported that the vagus nerve stimulator (vns) was placed with a decrease in seizure frequency but was complicated by sinus bradycardia and first-degree atrioventricular block requiring device removal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8530085
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #336 on: May 10, 2019, 02:40:21 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2019
Event Type  Injury   
Event Description
It was reported that this patient experienced a bradycardia event. The doctor requested that the patient¿s device¿s output current be disabled so that the surgeon could perform an oral cavity surgery on the patient (which was approved by the patient¿s neurosurgeon). The patient¿s output current was successfully disabled prior to surgery. After surgery the settings were returned to their original settings. At this time the patient¿s heart rate decreased from 70 bpm to 35 bpm, which was suspected to be due to stimulation. At the discretion of the surgeon who performed the oral cavity the output current was decreased (not disabled) to 1. 5ma, at which point there was no change in heart rate during stimulation. No system diagnostics had been performed prior to surgery. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8497210
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #337 on: May 11, 2019, 04:07:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/03/2019
Event Type  Injury   
Event Description
It was reported that the patient's heart was out of rhythm at a follow-up appointment and when the vns generator was turned off, the patient's heartbeat was back in rhythm. When the patient's generator was programmed back on the patient's heart rate dropped into the 30s (bpm). It was reported that the patient's generator was disabled. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8553158
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #338 on: June 07, 2019, 05:57:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the icu and that assistance was requested by the icu physician to confirm the vns was working correctly. Information was later received that the patient had aspirated, had pneumonia, had septic shock, and a bradycardia episode. The physician was unfamiliar with the vns device, he could not provide an assessment on the relationship of the events to the device. Follow up with the icu physician determined that the physician decided to have the output currents set to 0ma during the hospitalization to monitor the patient. System diagnostics were also performed with all results reported to be within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8575447
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #339 on: June 07, 2019, 08:57:27 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/22/2019
Event Type  Injury   
Event Description
Initial report was that a primary care physician told a patient that his vns could be causing the patient¿s bradycardia. Further information was received that there was a discrepancy between the primary care physician and vns treating physician about whether or not the patient was experiencing bradycardia. Further information was received that bradycardia was observed in the patient's vns trends data by the vns treating physician. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8620791
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #340 on: June 08, 2019, 07:26:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/17/2019
Event Type  Injury   
Event Description
It was reported that the patient when the device was turned on, the patient began to have bradycardia. Additional information was received stating that the patient had not had bradycardia during the system diagnostics run, but when the device was turned up to the 2. 0 ma output current setting the patient had previously been set to, there was a period of 30 seconds in which she only registered two pulses. The output current was lowered to 1. 0 ma and then the patient was fine again. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8604907
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #341 on: June 09, 2019, 02:16:23 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Initial report was that a patient was admitted into a hospital due to tachycardia. The patient recently started to experience bradycardia that occurred with low blood pressure. The physician did not know if the events were occurring with device stimulation. Further information was received that the patient had been admitted to the hospital due to the infection. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8649294
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #342 on: June 14, 2019, 06:31:14 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
Initial report was that a patient experienced multiple vagal syncopes, fainting, and bradycardia that the patient¿s cardiologist believed were related to vns. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8656770
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #343 on: July 06, 2019, 12:19:40 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported via another medical device manufacturer representative that the patient was becoming severely bradycardic and it was wondered if this was related to the vns. The patient was not found in the vns manufacturer's database. It was stated that the patient was unconscious and could not be asked for additional information. It was reported that the patient was experiencing periods of bradycardia and asystole. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8684960
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #344 on: July 06, 2019, 12:20:18 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a facility was enquiring whether the patient's bradycardia was related to vns. The patient was implanted approximately five years prior to the onset of the reported bradycardia. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8679889
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #345 on: July 16, 2019, 11:54:36 PM »

Model Number 101
Event Date 09/04/2009
Event Type  Injury   
Event Description
Reports indicated a vns therapy patient was admitted to the hospital for bradycardia and was in the ccu. The cardiologist feels that the patient's bradycardia may be related to his vns. Additional information received indicated the physician originally believed the vns may have had something to do with the bradycardia and wanted to turn it off but later decided the patient still needs a pacemaker. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1491034
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #346 on: July 30, 2019, 11:02:22 AM »

Model Number 105
Event Date 10/01/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient began developing bradycardia and syncope 5 months prior. The syncope occurred several times per hour. The physician stated the bradycardia and syncope are most likely related to one another, but the relationship to vns was not confirmed. The events began when the patient's device settings were increased to normal mode: 1. 0ma/30hz/250usec/30sec/1. 1min magnet mode: 1. 25ma/250usec/60sec. No recent diagnostic tests have been performed. It was reported that using the magnet to turn off stimulation caused the events to cease. The physician changed the programmed the device off (0ma) on (b)(6) 2016 to verify if vns caused the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5600029
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #347 on: August 10, 2019, 03:46:03 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2019
Event Type  Injury   
Event Description
After implant surgery, the patient experienced four episodes of bradycardia and was non-responsive while in surgery recovery. It was noted that the patient was roused with a sternal rub and would then vomit. The device was programmed off after being programmed to 0. 25 ma at time of surgery and there were no further episodes. The nurse present with the patient did not believe that the episodes were occurring with stimulation. The patient was taken to the intensive care unit and no further episodes occurred. The patient was then programmed back to 0. 25 ma and has had no further side effects since then. The practitioners at the clinic noted that the events were believed to be related to anesthesia. Lead impedance was noted to be ok after implant. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8748532
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #348 on: August 10, 2019, 03:47:02 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/21/2019
Event Type  Injury   
Event Description
It was reported that a patient was having bradycardia after two years of vns treatment, with their first episode detected in (b)(6) 2019, with ventricular asystole of 15s and subsequent episodes of bradycardia. The output current was deceased and no episodes were then detected. It was stated that recently, the patient had episodes of bradycardia again and the neurologist decreased the output current and frequency. Further information was received that the patient was experiencing syncope-like episodes and appeared to be hospitalized due to this. The patient did not experience any traumatic events prior to the arrhythmia, and the patient did not have any triggers prior to the arrhythmia. It was stated that heart rate was provided prior to the event and during the event to be 84/min and 43/min respectively. It was stated that the arrhythmia does not correlate with the on time of the programmed device settings and the arrhythmia did not occur while performing system diagnostics. The arrhythmia did occur following a setting change. Following the findings from the ecg, the physician decided to decrease the device output parameters. The patient's seizures were well controlled with vns and aeds, but was admitted to the institution again due to syncope-like episodes and bradycardia in (b)(6) 2019. The physician did not find correlation between duty cycles of vns and bradycardia. It is stated that the arrhythmia is believed to be related to the vns therapy stimulation and that the vns stimulation exacerbated or co-currently contributed to the arrhythmia. It was also stated that the believed relationship between the vns and the bradycardia is due to high settings. In consultation with cardiologist, the vns was disabled. After the vns was disabled, the patient is neurologically stable, without seizures, and his repeated ecg reveals normal sinus rhythm. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8842887
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #349 on: August 10, 2019, 03:47:59 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the er for bradycardia, syncope, and a possible heart blockage. The physician was questioning whether this was related to the vns. It was stated that the patient had been bradycardic ever since implant. A review of device history records revealed that the generator and lead passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764641
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64233


« Reply #350 on: September 07, 2019, 03:01:31 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2019
Event Type  Injury   
Event Description
It was reported that a patient is experiencing bradycardia and the patient's physician requested further data or literature on bradycardia and vns therapy. The physician does not know at this time whether the bradycardia is related to the vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8885003
Logged
Pages: 1 ... 10 11 [12]   Go Up
Print
Jump to: