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dennis100
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« on: June 29, 2010, 10:06:48 PM »

Epilepsia. 2009 Apr;50(4):928-32. doi: 10.1111/j.1528-1167.2008.01918.x. Epub 2008 Dec 4.
Late-onset periodic asystolia during vagus nerve stimulation.
Iriarte J1, Urrestarazu E, Alegre M, Macías A, Gómez A, Amaro P, Artieda J, Viteri C.
Author information
Abstract
Cardiac changes may occasionally occur during vagus nerve stimulation (VNS) used in epileptic patients. As they can be potentially life-threatening, it is important to detect them, and this is why an intraoperative test is performed during the implantation. Few cases of asystole during this test have been described. Only one patient with late-onset bradyarrythmia caused by VNS has been reported. This patient had been implanted 2 years and 4 months before the episode. We present another case of late asystole in a patient whose VNS had been implanted 9 years before the arrhythmia onset. In our patient, each run of stimulation produced bradyarrhythmias and very often severe asystolia due to atrium-ventricular block.

http://www.ncbi.nlm.nih.gov/pubmed/19055490
_________________________________________________

Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization Life Threatening  
Event Description  
Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295
  
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« Reply #1 on: June 29, 2010, 10:07:56 PM »

Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization  
Event Description  
It was reported that a pt developed drop attacks in 2009 (approximately 7. 5 years after being implanted which lead to the pt being hospitalized. The pt also had periodic bradycardia. The device was programmed off and the bradycardia and drop attacks resolved. Additional information received from the pt's physician revealed that the pt does not have a history or a family history of cardiac events. The pt presented with syncope which suggested some sort of arrhythmia. The pt's heart rate prior to the event was 70 and decreased to 10 during the event. The blood pressure was 120/80 prior to the event; however, no blood pressure readings were provided after the event. There were no traumatic events, medication changes, or triggers such as smoking, caffeine intake, etc. That preceded the onset of the bradycardia. The pt is currently taking zonegran, lamictal, and topamax. The bradycardia did not occur during device diagnostics nor did it occur following a setting change. An ecg and polysomnography were performed to diagnosed the arrhythmia. The arrhythmia (bradycardia) is believed to be related to device stimulation and is exaggerated by the device. The pt was hospitalized for the length of testing needed to diagnose the arrhythmia. The arrhythmia has not recurred since the device has been programmed off. Good faith attempts to obtain additional information are currently being made.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558273
 

« Last Edit: December 12, 2014, 04:31:45 PM by dennis100 » Logged
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« Reply #2 on: June 29, 2010, 10:09:21 PM »

Event Date 09/04/2009
Event Type  Injury   Patient Outcome  Hospitalization;  
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.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1491034

« Last Edit: December 12, 2014, 04:31:07 PM by dennis100 » Logged
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« Reply #3 on: June 29, 2010, 10:10:36 PM »

Event Date 10/01/2006
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated that the pt experienced bradycardia during a hosp visit following a change in the device parameters. After the parameters were readjusted, the bradycardia resolved. No further cardiac problems have been reported to the physician since the event.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842017

« Last Edit: December 12, 2014, 04:30:31 PM by dennis100 » Logged
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« Reply #4 on: June 29, 2010, 10:12:38 PM »

Event Date 03/19/2009
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization Life Threatening  
Event Description  
It was reported that the pt was admitted to the hosp in 2009 for bradycardia. Per the reporter, her heart rate was in the 30-40 bpm range. When the pt's magnet was placed over pt's generator to disable it, the bradycardia resolved. Pt's generator was programmed off a few days later. All attempts for further info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1366380

 
« Last Edit: December 12, 2014, 04:30:12 PM by dennis100 » Logged
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« Reply #5 on: June 29, 2010, 10:13:58 PM »

Event Date 06/01/2003
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization Life Threatening  
Event Description  
Reporter indicated that vns pt was hospitalized due to bradycardia. It was reported that the pt uses a bipap machine at home and that they became unresponsive and was taken to the hosp. The pt was reportedly placed on a ventilator, not for the oxygen but for the pressure. The pt's heart rate was in the 40's at this time. Ekg reviewed by a cardiologist reportedly indicated that the pt had a sinusbrady rhythm and the cardiologist believed that it was due to the vns. The pt's neurologist does not believe that this condition is related to the vns therapy. There had been no increases in vns therapy settings for over a year.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=473271
« Last Edit: December 12, 2014, 04:29:53 PM by dennis100 » Logged
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« Reply #6 on: June 29, 2010, 10:15:19 PM »

Model Number 102R
Event Date 03/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Further follow-up revealed that neurologist believes the vns therapy may possibly be related to the reported events. Neurologist indicated that the pt's light-headedness seems to correspond to higher current settings. Neurologist also indicated that the pt's vital signs remain normal during the light-headedness. Neurologist reported that the pt's seizures have remained stable at lower current settings. The pt does not have any previous cardiac history and is currently undergoing cardiology review.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's requested for additional information from treating neurologist. H. 6. Vns therapy system labeling lists dizziness, facial flushing, and heart rate/rhythma changes as potential adverse events possibly associated with surgery or stimulation.

Event Description
Approximately two months after generator replacement surgery, vns pt developed light-headedness, facial flushing and episodes of bradycardia and pauses that occur only during device stimulation cycles. The pt's device is programmed to stimulate once every 20 minutes. It is not known whether the pt has any cardiac history. There had been no recent medication changes that could have contributed to the reported event. A cardiac work-up is being considered and the pt plans to follow-up with treating neurologist. Invesigation to date has been unable to determine the cause of the reported event.

Event Description
Further follow-up revealed that the pt now only experiences light-headed feelings with magnet mode stimulation and that the light-headed feelings do not occurr during normal mode stimulation. Holter monitoring is planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=593001


 
 
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« Reply #7 on: June 29, 2010, 10:16:41 PM »

Event Date 03/13/2010
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
It was initially reported that a pt was having episodes of bradycardia with a heart rate in the 30s and was also experiencing a few episodes of asystole (each about 5 seconds in duration). The cardiologist thought it may possibly be related to the pt's vns device. A company rep went to the pt's next appt and was unable to interrogate the pt's device due to believed end of service. A battery life calculation was performed using the pt's programming history available in the in-house database (current from date of implant to (b) (6) 2009) and it was found that the device may be at end of service. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1658341
 

 
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« Reply #8 on: June 29, 2010, 10:18:13 PM »

Event Date 09/09/2008
Event Type  Injury   Patient Outcome  Other;  
Event Description  
Reporter indicated that a vns pt was experiencing bradycardia and a change in qt intervals. Attempts for further info regarding the pt and bradycardia event are in progress.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1195136
 
 
« Last Edit: December 12, 2014, 04:28:42 PM by dennis100 » Logged
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« Reply #9 on: June 29, 2010, 10:20:09 PM »

Event Date 05/15/2003
Event Type  Injury   Patient Outcome  Required Intervention; Life Threatening  
Event Description  
Reporter indicated that vns pt has been experiencing severe symptomatic bradycardia believed to be related to the vns therapy. Prior to the bradycardia event, device parameters were reduced due to coughing with stimulation. The pt's generator was programmed to off with plans to perform a cardiac workup. Further follow-up revealed that revision surgery was scheduled to reposition the lead electrodes on the vagus nerve. The pt had reportedly experienced shortness of breath with the episodes of bradycardia and even had one episode that sounded like a brief cardiac arrest as described to treating neurologist by the pt's spouse. The pt indicated that the bradycardia events coincide with stimulation. The pt has reportedly had improvement in seizure control with the vns therapy.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=466314

 
 
« Last Edit: December 12, 2014, 04:28:22 PM by dennis100 » Logged
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« Reply #10 on: June 29, 2010, 10:21:37 PM »

Event Date 09/01/2005
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization Life Threatening  
Event Description  
Reporter indicated that vns pt was seen in hosp emergency room due to severe bradycardia. Device diagnostic testing was within normal limits, indicating proper device function. The pt was then admitted to the hosp due to an increase in seizure activity. The pt was implanted with a cardiac pacemaker. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=640285
« Last Edit: December 12, 2014, 04:27:47 PM by dennis100 » Logged
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« Reply #11 on: June 29, 2010, 10:23:23 PM »

Event Date 11/10/2005
Event Type  Injury   Patient Outcome  Hospitalization; Life Threatening  
Event Description  
The reporter indicated that the pt began experiencing bradycardia and dizziness approx one month following her vns implant. The pt was hospitalized as her rate dropped in the thirties (beats per minute). The pt's baseline heart rate prior to the vns therapy was 66 bpm. The pt's seizure have decreased with the vns therapy. It was also reported that the pt's heart rate is currently 59-60 bpm without symptoms.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=652916
 
 
« Last Edit: December 12, 2014, 04:27:16 PM by dennis100 » Logged
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« Reply #12 on: June 29, 2010, 10:25:30 PM »

Event Date 08/28/2006
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization  
Event Description  
Reporter indicated patient was hospitalized after a seizure and experienced bradycardia with stimulation, during the hospital stay. The device was disabled and the bradycardia stopped. Diagnostics were performed on the device after hospital release and yielded normal results. The bradycardia event did not recur with diagnostic testing. In addition, the patient was monitored for a 12-hour period with device stimulation and no bradycardia occurred. The device remains activated and patient has not had any more bradycardic episodes. The physician has stated "the bradycardia was an incidental, but significant finding as the heart rate was 25" and that the vns caused the bradycardic events while the patient was hospitalized for seizure. No serious injury was reported.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=767390
 
« Last Edit: December 12, 2014, 04:26:56 PM by dennis100 » Logged
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« Reply #13 on: July 01, 2010, 04:54:19 AM »

Event Date 10/22/2007
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated that a patient's vns generator and lead were replaced due to bradycardia.  
  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=955129
 
« Last Edit: December 12, 2014, 04:26:02 PM by dennis100 » Logged
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« Reply #14 on: July 01, 2010, 04:55:19 AM »

Event Date 06/15/2008
Event Type  Injury   Patient Outcome  Hospitalization;  
Event Description  
Reporter indicated that a vns pt's home nurse stated that the pt's pulse rate was 35 bpm and that the pt was admitted to the hospital. The physician had not yet seen or evaluated the pt, but he reported that he does not believe the vns was the cause of the bradycardia, and the physician also stated that he is doubtful that the pt actually experienced bradycardia. Attempts for add'l info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1078138
 
 
« Last Edit: December 12, 2014, 04:25:41 PM by dennis100 » Logged
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« Reply #15 on: July 01, 2010, 04:56:09 AM »

Event Date 01/01/2003
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
It was reported in a scientific article that a pt experienced event of bradycardia along with vns stimulation. Ekg recording and monitoring of the pt showed that the heart rate was decreased and ranged from 10 to 20 beats per min. This decrease in heart rate correlated with the vns stimulation on time. The event took place at vns stimulation parameters ranging from 1. 75 to 2. 5 ma. No additional info was provided.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1643728

 
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« Reply #16 on: July 01, 2010, 04:57:13 AM »

Event Date 07/01/2008
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated a vns has been implanted for 8 years and is now being monitored for episodes of bradycardia. The physician does not think the vns is causing the bradycardia however they are monitoring pt as he is not sure. It was also reported the pt has seizures that causes episodes of bradycardia. The pt's vns settings were increased, but later the vns was disabled. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1147180
 
« Last Edit: December 12, 2014, 04:24:50 PM by dennis100 » Logged
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« Reply #17 on: July 01, 2010, 04:58:26 AM »

Event Date 09/01/2003
Event Type  Injury   Patient Outcome  Hospitalization; Life Threatening  
Event Description  
Reporter indicated that vns patient was hospitalized in the icu for a couple of days due to bradycardia. It was reported that when device settings were increased, the patient coughed more than they did at lower settings. There has reportedly been some improvement in the patient's seizures.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=493158
« Last Edit: December 12, 2014, 04:24:31 PM by dennis100 » Logged
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« Reply #18 on: July 01, 2010, 04:59:50 AM »

Event Date 11/01/2008
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Reporter indicated that a vns pt was hospitalized due to kidney problems. During this hospitalization, the hosp physician noted that the pt was experiencing bradycardia. Further follow up revealed that the pt was to undergo surgery for a pacemaker. Good faith attempts to obtain additional info have been unsuccessful. The relationship between the bradycardia event and the vns therapy is unk at this time.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1248023
 
« Last Edit: December 12, 2014, 04:24:12 PM by dennis100 » Logged
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« Reply #19 on: July 01, 2010, 05:01:18 AM »

Event Date 10/01/2008
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
It was reported to the mfr that the vns patient has been experiencing bradycardia. It was indicated that the patient's cardiologist decided to implant a pacemaker in the patient and program the vns generator to 0ma temporarily. The relationship between bradycardia and vns therapy is unk at this time. Good faith attempts to obtain additional info regarding the reported event have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1242942
 
« Last Edit: December 12, 2014, 04:23:52 PM by dennis100 » Logged
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« Reply #20 on: July 01, 2010, 05:02:25 AM »

Event Date 10/14/2008
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated a vns patient was experiencing bradycardia during vns therapy stimulation. The physician has "looked very closely at the" chest x-ray, and "cannot see a lead break or disconnection. " additionally, the physician suspects "there is nothing wrong with the vns. " additionally, the manufacturer reviewed the x-rays and the visualized portion of the lead body appears to be void of any gross discontinuities or acute angles and electrode placement appears to be in the correct orientation. No anomalies were identified in the visualized portion of the patient's vns device which could have contributed to the reported events. Good faith attempts have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1235208
 
 
« Last Edit: December 12, 2014, 04:23:33 PM by dennis100 » Logged
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« Reply #21 on: July 01, 2010, 05:03:41 AM »

Event Date 01/01/2004
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Treating cardiologist reported that a vns patient was experiencing black out spells. The patient had her generator replaced for an unknown reason and is still experiencing the blackout spells. The physician reportedly believes the patient is having bradycardia due to vns therapy which is causing the patient to have the black out spells and then subsequently a seizure. Physician states that he plans on having the device programmed off to assess vns therapy relationship. Attempts for further information have been used to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1269757
« Last Edit: December 12, 2014, 04:23:13 PM by dennis100 » Logged
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« Reply #22 on: July 01, 2010, 07:48:22 AM »

Event Date 03/25/2009
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
It was reported that the vns patient experienced a bradycardic episode. The patient's heart rate returned to normal level within 24 hours. No interventions were taken for the reported event. Follow-up revealed that the patient did not have a medical history of bradycardia pre-vns. The relationship between the reported event and vns therapy is unknown at this time. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.  
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1368752
 
« Last Edit: December 12, 2014, 04:22:45 PM by dennis100 » Logged
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« Reply #23 on: July 01, 2010, 07:49:20 AM »

Event Date 12/27/2002
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization Life Threatening  
Event Description  
Reporter indicated that vns patient was admitted to the hospital in 2002 and is currently in the icu due to recurring seizures which caused the patient to lose consciousness. The physician plans to program the patient's device to off because he feels that the stimulation is causing the patient bradycardia. Further follow-up revealed that the patient was admitted to the hospital in december to a medicine floor and approximately 7-10 days later was moved to the icu because of blood pressure decrease and bradycardia. The vns was programmed to off in an effort to rule out possible causes. After programming the device to off and administering medication (type not known), the patient's bradycardia resolved. It was also noted that the patient's cortisol level was low. The vns was programmed back to on the next day and the bradycardia did not recur. Physicians reportedly do not believe that the patient's problems are related to the vns.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=441938

  
« Last Edit: December 12, 2014, 04:22:22 PM by dennis100 » Logged
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« Reply #24 on: July 02, 2010, 12:14:45 AM »

Event Date 05/27/2009
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
A vns pt's cardiologist indicated that he noticed that the pt was having intermittent heart block (p wave, but no qrs wave) for duration of three to four seconds recently. The cardiologist indicated that he did not know if the issue was related to vns therapy and added that pacemaker implantation would likely occur. Good faith attempts for additional info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1408615
 
« Last Edit: December 12, 2014, 04:21:59 PM by dennis100 » Logged
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« Reply #25 on: July 02, 2010, 12:17:57 AM »

Event Date 08/03/2009
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
It was initially reported by the treating neurologist that during a routine physical by another physician, the patient was reported to have bradycardia. The patient's hr was recorded at 39bpm. The patient has not been showing signs of shortness of breath or lightheadedness, nor does he has a history of the bradycardia. The neurologist is unsure of onset of event as she has not closely monitored him for this before. The patient was given a holter-monitor and she was still waiting for the results. The patient's output current is 1. 5ma, 30sec on, and 3. 0min off. The physician is concerned about disabling the device, as the patient has been seizure-free for 4 months. There has been no change in the patient's medications, but it was noted that he is on cholesterol medication. The patient is said to be a runner and has never experienced any problems before leaving the device on while exercising. The patient has been referred to a cardiologist for evaluation. Attempts to obtain additional information were not provided by the site.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1458546
 
« Last Edit: December 12, 2014, 04:21:32 PM by dennis100 » Logged
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« Reply #26 on: July 02, 2010, 12:19:06 AM »

Event Date 04/18/2000
Event Type  Injury   Patient Outcome  Required Intervention; Life Threatening  
Event Description  
Patient experiences bradycardia when stimulation is programmed to 2. 5ma or higher output current. Patient is asymptomatic at current setting of 1. 5ma output current.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=284389


 
« Last Edit: December 12, 2014, 04:20:56 PM by dennis100 » Logged
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« Reply #27 on: July 02, 2010, 12:20:13 AM »

Event Date 06/05/2001
Event Type  Injury   Patient Outcome  Required Intervention; Life Threatening  
Event Description  
Reporter indicated that patient experienced bradycardia post-implant. Upon being admitted to the hospital, the patient's heart rate was 69 beats per minute. In the recovery room the rate had decreased to 37-38 bpm. Recovery room staff placed magnet over the device to turn it off and the heart rate increased to 45 bpm. Physician reproduced the bradycardia by removing the magnet from over the device. Device was programmed to off.  
  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=340647



 
« Last Edit: December 12, 2014, 04:20:36 PM by dennis100 » Logged
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« Reply #28 on: July 02, 2010, 12:21:17 AM »

Event Date 10/07/2009
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization  
Event Description  
Reporter indicated a vns pt was experiencing bradycardia, central apnea, and obtundation with vns stimulation. The vns is beneficial for the pt's seizure control, but the pt has a significant history of bradycardia with vns since 2001. The previous bradycardia event is reported via mdr #1644487-2006-00432. The apnea and obtundation, and continuing bradycardia, are noted since the pt was reimplanted with new vns products in 2009. If the vns is disabled for several hours, the pt has frequent, uncontrolled seizures. If the vns output current is reduced to 1. 0ma, the seizures increase. The pt has progressive bradycardia and obtundation, mostly responsive to arousal, within days to weeks after the vns output current is increased to 1. 25ma. The pt has central apnea, awake and asleep, when the vns duty cycle is increased. The apnea is intermittent and timed to periodicity of the stimulator. On the one occasion that a higher duty cycle was tried at 1. 0ma, the respiratory depression was progressive and lead to respiratory failure. The respiratory failure was treated in the intensive care unit at the hospital and managed by changing the vns settings. The pt is currently stable with infrequent partial seizures only as of two months later at his last clinic visit. The current vns settings are 1. 2ma/25 hz/250 pulsewidth/21 sec on/5 min off.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1571192
 
« Last Edit: December 12, 2014, 04:20:09 PM by dennis100 » Logged
dennis100
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« Reply #29 on: July 02, 2010, 12:22:31 AM »

Event Date 07/15/2003
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization Life Threatening  
Event Description  
Reporter indicated that vns patient has been experiencing bradycardia with hypotension. On the day that stimulation was initiated, the patient's blood pressure dropped and their heart rate decreased from baseline 70's to 55-60. Symptoms subsided when stimulation was temporarily discontinued using the magnet. No charges in heart rate or blood pressure were noted during implant surgery. There were no changes in heart rate or blood pressure during device diagnostic testing approximately 6 days after the event. Treating surgeon plans to admit patient hospital for ekg evaluation.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=478589

 
 
« Last Edit: December 12, 2014, 04:19:46 PM by dennis100 » Logged
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