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dennis100
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« on: May 13, 2011, 11:36:54 AM »

Event Date 04/01/2009
Patient Outcome Other;
Event Description
Pt had cluster of 7 seizures over 2 days, resulting in emergency room visit and hospitalization on epilepsy monitoring unit. A few days prior to this, patient had a suspected seizure that was different in appearance than prior events. Medication changes were made. During the hospitalization, patient was placed on eeg telemetry where two seizures were recorded with a period of asystole lasting 18 seconds during the seizure. The patient did not have a prior history of bradycardia or cardiac difficulties. Since patient had an implanted vagus nerve stimulator, this was interrogated and tested to ensure that the device was working properly. Testing the device was not associated with change in heart rate. Epilepsy team believes that the seizure was associated with asystole and not the vagus nerve stimulator, but since asystole had been reported in a few instances of new implants with vns, the vns device was watched carefully in this patient. A cardiac pacemaker was implanted and the vns was tested during this procedure. The vns was not found to interfere or affect the cardiac pacemaker. The vns is gradually being reprogrammed to the patient's usual settings as a treatment for her seizures. Patient's medications were adjusted during the hospitalization, and she was discharged twelve days later in 2009. Pt seen in clinic today for follow-up of vns and no further problems have been noted. Diagnosis or reason for use: intractable epilepsy.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1365329
« Last Edit: July 26, 2013, 10:47:02 PM by dennis100 » Logged
dennis100
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« Reply #1 on: May 13, 2011, 11:38:10 AM »

Event Date 01/15/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was initially reported by the hospital that the pt was in the icu for bradycardia, it is unk the relationship to vns. The pt does have a history of cardiac issues and is implanted with a pacemaker. Good faith attempts to gain more info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1999403
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dennis100
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« Reply #2 on: May 13, 2011, 11:39:07 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
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dennis100
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« Reply #3 on: May 13, 2011, 11:39:58 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
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dennis100
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« Reply #4 on: May 13, 2011, 11:41:20 AM »

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
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dennis100
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« Reply #5 on: May 13, 2011, 11:43:00 AM »

Event Date 08/01/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer by the patients treating neurologist that the pulse generator, when tested at a recent follow-up visit, was showing that the device was nearing end of service as the elective replacement indicator (eri flag) was set to yes. The neurologist reported that diagnostic testing revealed normal device function, but that the device eri was set to yes. The physician further explained that the patient has been experiencing an increase in seizure frequency and it was also noted that the patient has been experiencing asystole events, which occur up to 9 seconds with seizures. The physician noted that there is always some prolongation of the asystole with every seizure, but may not always be that long. She noted also that the cardiac event did not seem to be when the vns device stimulates, but rather when the patient has seizures. The physician indicated that the patient is new to her practice, and the asystole was found 'unexpectedly'. The physician explained that it may be that because the generator is nearing end of service, so patient is having more seizures and thus having more asystole events. The patient had surgery where the generator was replaced, and the asystole events have continued per the physician. The physician explained that the patient also had a cardiac pacemaker placed and was discharged home. The plan is to admit the patient to the epilepsy monitoring unit with simultaneous holter monitoring. Good faith attempts to obtain additional information regarding the believed relationship of the cardiac event to vns are currently underway. In addition, good faith attempts to obtain the explanted pulse generator returned to manufacturer for analysis have been made, but the device has not been returned to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1839744
« Last Edit: July 26, 2013, 10:48:46 PM by dennis100 » Logged
dennis100
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« Reply #6 on: May 13, 2011, 11:44:18 AM »

Event Date 04/22/2008
Event Type Injury Patient Outcome Required Intervention; Hospitalization
Event Description
Initial reporter indicated that the vns pt was having gradual 10 sec pauses to her heart rate. Heart rate is 30-40 beats per minute. It was thought by the pt's treating neurologist's office that the event could possibly be related to pt stress and being overweight. The pt was implanted with the vns in 2005 and this is new event for the pt. The pt has had no previous cardiac interventions taken. The pt had a pacemaker inserted. All system diagnostic testing was within normal limits after the pacemaker insertion. Good faith attempts have been made for additional info surrounding the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1046053

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dennis100
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« Reply #7 on: May 13, 2011, 11:45:01 AM »

Event Date 01/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that a vns patient required the implantation of a defibrillator for ventricular disease and bradycardia. The vns was disabled due to the ventricular disease. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=951094

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dennis100
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« Reply #8 on: May 13, 2011, 11:45:36 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
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dennis100
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« Reply #9 on: May 13, 2011, 11:46:27 AM »

Event Date 05/05/2004
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt developed an infection at the chest incision site. It was reported that the pt's generator was implanted on the right side with the lead placed on the left side because the pt is also implanted with a cardiac pacemaker. It was reported that the pt has a scab at the chest incision site and that the site was swollen with a small amount of nighttime bleeding. Treating neurosurgeon prescribed 2 oral antibiotics and will possibly prescribe iv antibiotics depending on results of laboratory tests.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=532807
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dennis100
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« Reply #10 on: May 13, 2011, 11:47:12 AM »

Event Date 06/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt was hospitalized due to low heart rate. It was reported that the bradycardia persisted after the pt's device was programmed to off. The vns therapy system was explanted one week after stimulation was discontinued and the pt was implanted with a cardiac pacemaker. Treating physicians have reportedly been unable to determine the cause of the bradycardia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=533658
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dennis100
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« Reply #11 on: May 13, 2011, 11:47:43 AM »

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

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dennis100
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« Reply #12 on: May 14, 2011, 05:31:33 AM »

Event Date 09/01/2005
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt developed an infection at the site of the vns implant and that the site was open with packing. The pt is also implanted with a cardiac pacemaker. Further follow-up with treating physician revealed that the pt experienced local wound breakdown in the axilla approx 10-14 days post vns implant. Physician indicated that no infection was present as evidenced by normal white blood count and esr as well as absence of fever. The wound was treated prophylactically with antibiotics. It was reported that the healing of the wound was nearly complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=640593
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dennis100
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« Reply #13 on: May 14, 2011, 01:02:58 PM »

Model Number 102
Event Date 01/10/2006
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Event Description
The reporter called the manufacturer to request a representative be present during an icd implant. The reporter indicated that a vns patient had experienced a heart attack. The patient had been defibrillated "numerous" times the day of his heart attack, prior to the icd implant. The vns system was checked and found to be working appropriately. The vns generator was disabled for the icd surgery. The icd implant was performed; the icd was placed in the patient's right chest, leaving the vns system on the left side. Following the surgery, the vns generator was turned back on to the previous settings. It was tested with icd, and the systems were found to be working appropriately. There is no evidence suggesting that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=672734
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dennis100
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« Reply #14 on: May 19, 2011, 02:16:24 AM »

Event Date 12/21/2007
Event Type Malfunction
Event Description
Reporter indicated that diagnostic testing on a vns pt resulted in high lead impedance. Prior to the high impedance, the pt underwent radiation treatment for a lung tumor and had a pacemaker implanted. The physician indicated that the high impedance was "probably due to the tumor encroaching on the lead. " revision surgery is likely. Good faith attempts for additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1046609

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dennis100
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« Reply #15 on: May 20, 2011, 03:05:02 AM »

Event Date 08/25/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported to the manufacturer that the vns patient was experiencing tachycardia. The patient's heart rate was consistently around 99-108. The patient has her pacemaker implanted on the left and her vns generator on the right with more than 7-10 inches away. We were informed that every time the patient's vns device delivered stimulation, the patient's heart rate dropped and the pacemaker attempt to correct this by firing to increase heart rate. The physician suggested the patient turn the vns device off by taping the magnet over the generator. The patient was informed to visit with her neurologist and cardiologist to resolve the issue. Good faith attempts to obtain additional information regarding this event are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1175970
« Last Edit: July 26, 2013, 10:49:23 PM by dennis100 » Logged
dennis100
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« Reply #16 on: June 03, 2011, 02:23:10 PM »

Event Date 04/27/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
A patient reported that during implant surgery, the surgeon implanted the vns generator on the right side of the patient's chest as the patient was implanted with a pacemaker on the left side. During implant, the patient experienced asystole and had to be resuscitated. During surgery, the patient also experienced a large seizure when the vns was programmed on and now the patient is having more seizures than she did prior to being implanted with the device. The patient also stated that the device is pushing up against her skin which causes pain while dressing. Per the patient, the surgeon stated that the generator battery may have been used up during surgery, and he was unsure if the device was still functioning. Follow up with the neurologist revealed that the patient has a history of arrhythmia. The generator is registering magnet swipes. He does not know if the increase in seizures is above baseline levels. The protrusion response was that the device looks no different from any other patient other than it being on the right side. He will do a symptomatic therapy for the pain and possible consultation with a surgeon for a revision of the implant if desired by the patient. He does not know of any trauma or manipulation. Good faith attempts to obtain additional information from the surgeon have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1851128
« Last Edit: July 26, 2013, 10:50:09 PM by dennis100 » Logged
dennis100
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« Reply #17 on: June 06, 2011, 02:21:36 AM »

Event Date 05/01/2002
Event Type Malfunction Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient has not felt stimulation for "a couple of months" and has experienced an increase in seizures. Device diagnostic testing resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The eri (elective replacement indicator) flag was no, indicating that the patient's generator was not at the end of service. The patient's lead is implanted on the left vagus nerve, but the generator is implanted on the right side of the chest since the patient has another implanted device on the left. Further follow-up revealed that surgery is scheduled for 2002 to replace both the generator and lead.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=412138

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dennis100
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« Reply #18 on: June 08, 2011, 12:26:37 AM »

Event Date 02/29/2004
Event Type Death Patient Outcome Death;
Event Description
During a six-month post-implant follow-up call, it was discovered that the pt had expired. The reporter indicated that the pt died due to heart problems. The pt also had an implantable defibrillator. The vns system was not explanted. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=519000
« Last Edit: July 26, 2013, 10:50:55 PM by dennis100 » Logged
dennis100
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« Reply #19 on: June 08, 2011, 12:15:52 PM »

Event Date 07/26/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt was hospitalized due to syncope and that monitoring revealed some episodes of intermittent bradycardia. The pt's family member reported that the pt had a slow heart rate before vns implant and that after implant, the pt's heart rate has been slower with some pauses. The pt's cardiologist reportedly believes that the vns has exacerbated the pt's pre-existing condition and that the pt should now be implanted with a cardiac pacemaker.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=540603
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dennis100
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« Reply #20 on: June 09, 2011, 01:14:16 AM »

Event Date 04/13/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported to our country manager in (b)(6) that they had a vns pt implanted with a model 101 which has been implanted for 9 yrs, and is an extremely good vns responder. Over the past 6 months, the pt had reported to his general practitioner that they were having "odd" turns, which their physician initially attributed to focal seizures. However the pt had a cardiological review also, and the ecg showed that he was having 12 second pauses at the time of stimulation. On =30secs, off = 3 mins, so every 3 mins, there was a 12 second pause. The cardiologist contacted our country rep to ask her to switch the device off but unfortunately, the pt had recently left (b)(6) for a six week holiday in (b)(6). The nurse is attempting to make contact through family members to contact the pt and find a vns treating physician in (b)(6). There is also a query as to whether the pt could have a cardiac pacemaker implanted alongside their vns, because they do not want him to lose his therapy. The pt does not have a medical history of this prevns implantation. Once the pt returns from their vacation they will be admitted to hospital for some cardiac monitoring to plan the next course of action. If further info is attained another report will be sent.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2096034

« Last Edit: July 26, 2013, 10:52:01 PM by dennis100 » Logged
dennis100
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« Reply #21 on: June 09, 2011, 01:14:51 AM »

Event Date 03/28/2011
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
It was reported that the vns pt has been experiencing 3rd degree av heart block and bradycardia. The physician has stated that the pt has been hospitalized and will likely need a pacemaker. The physician has stated that the arrhythmia occurs even when vns stimulation has been disabled. The physician still feels however, that there may be a partial relationship of the vns stimulation to the arrhythmias. Attempts for further info have been unsuccessful to date.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082984
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dennis100
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« Reply #22 on: June 12, 2011, 12:35:32 AM »

Event Date 07/06/2006
Event Type Injury Patient Outcome Life Threatening;
Event Description
A vns patient indicated that he was experiencing dizzy spells which prompted him to visit the emergency room. In the emergency room, an ekg was performed and the results indicated a normal sinus rhythm without stimulation and sinus arrhythmia with occasional premature ventricular complexes during stimulation. It was also indicated that the patient may have possible left atrial enlargement. The patient's device was subsequently disabled with his magnet reportedly causing him to slip "back into depression again. " the patient did indicate that he has a pre-existing history of bradycardia and that he wears a pulse oximeter monitor to alert him when "it hits 39."follow-up with the patient's cardiac surgeon, who had performed a cardiac exam a month after the patient's initial report, revealed that the patient showed no evidence of arrhythmia or heart enlargement. The patient indicated that he received surgical consult from another cardiac surgeon who reportedly did not diagnose him with any "major" heart condition. Later the patient indicated that he had failed a stress test and that his condition has "gotten to be severe bradycardia". The patient is now seeking surgical consult for the implant of a pacemaker. Good faith attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1393198

« Last Edit: July 26, 2013, 10:54:03 PM by dennis100 » Logged
dennis100
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« Reply #23 on: June 12, 2011, 12:37:09 AM »

Event Date 04/05/2005
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt became non-responsive when treating neurologist performed device diagnostic testing. The pt was taken to the hospital emergency room, at which time they were diagnosed with third degree heart block and bradycardia (heart rate 30 bpm). The pt's device was programmed to off. It was reported that implantation of a transveneous pacemaker was being considered. The pt was discharged home with the vns programmed to off and has reportedly not experienced any further episodes of third degree heart block in the absence of stimulation. To date, the pt has refused to have the vns device programmed back to on. The pt has reportedly experienced intermittent cardiac issues in the past. The pt reported chest and left arm pain three days befroe the reported event occurred, at which time they went to the hospital, but was discharge to home that same day. Device diagnostic testing at prior office visit approximately 7 months earlier was performed without incident but was uncomfortable for the pt. The test was within normal limits, indicating proper device function at that time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=599249

« Last Edit: July 26, 2013, 10:55:11 PM by dennis100 » Logged
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« Reply #24 on: June 12, 2011, 12:39:11 AM »

Event Date 04/01/2009
Event Type Injury Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
It was reported that the pt was experiencing an increase in seizures above pre-vns baseline. During these seizures, the pt was having episodes of asystole. Pt was hospitalized and implanted with a pacemaker as a result. Per the treating medical professional, it is unk if the increase in seizures and asystole are related to vns or stimulation. Device diagnostics are all within normal limits. A battery life calculation was run and shows there to be approximately 1. 61 years remaining until end of service. The pt's medication levels were measured and were at zero which indicates the pt has not been compliant with her medication. It is unk at this time if this had an effect on the seizures and/or asystole. Pt will be monitored and no further interventions are planned at this time. All attempts for additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1373576
« Last Edit: July 26, 2013, 10:56:37 PM by dennis100 » Logged
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« Reply #25 on: June 12, 2011, 12:43:00 AM »

Event Date 05/21/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt had a 1st degree heart block following chronic vns (pr interval approximately. 35 with periods of asystole of 2-3 seconds). A 24-hour ecg was performed. After programming the vns to off, the ecg immediately improved. Further follow-up revealed that the pt was diagnosed by a cardiologist with 3rd degree heart block and was hospitalized for pacing. It is suspected that the lead coils may be placed too near to the carotid branch. It was later reported that the pt still has a long pr interval and some asystole, but much less. The physician's opinion, the vns device was exacerbating an underlying cardiac problem that was not previously detected. Physician plans to admit pt for overnight monitoring to determine if the pt has epilepsy at all.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=401064
« Last Edit: July 26, 2013, 10:57:03 PM by dennis100 » Logged
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« Reply #26 on: June 12, 2011, 03:12:03 AM »

Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Further follow-up (discharge summay dated 2004) revealed that the pt originally received the vns system so that he coul reduce the medications he was taking. The vns did not appear to help, and the pt reportedly began to have recurring and more-frequent events. The pt reported that 80% of the seizures are without warming and 20% are preceded by the sensation of jejavu. The pt feels "generally not right" and has difficulty breathing. He will suddenly stop what he is doing and become pale. His lips will turn blue and he will fall from standing. He denies any convusions. The episodes last 20-30 seconds, sometimes accompanied by brief myoclonus and followed by postictal confusion of 1-20 minutes. There is frequent urinay incontinence but rarely bowel incontinence. The pt was admitted to the impatient monitoring svc to better identify and classify his events for the initial evaluatio of possible surgical intervention. The pt was placed on continuous video-eeg monitoring. He had normal waking background alpha frequency of 11 hz with normal drowsiness and sleep stages identified. The pt had normal, if any, identifable interictal epileptiform discharges. He had several clinical events recorded. The pt had an event where he went from his prior sinus heart rate to a progressive bradycardia,culminating in a 15-second pause that was followed by generalized flattering of the eeg background, followed by some generalized delta events. After this event a cardiology consult was obtained. This was the event that prompted the initial medwatch report. There was concern that the vns system may have contributed to the event, therefore, the vns device was deactivated. Because the pt had the vns device for quite sometime before the asystole event, it was felt by the epilepsy svc to be exceedingly unlikely that the vns device contributed to the episode of asystole. Following the initial event, the pt had several more events, though none were accompanied by significant asystole. It was reported that the episode of asystole may have been triggered by a subtle seizure activity involving the frontal lobe, and there was no way to guarantee that this would not recur. The vns device was not turned back on at this point and it is unk if the vns device is presently activated.

Event Description
Reporter indicated that vns patient was experiencing episodes of asystole. The cause of the episodes is unknown. The patient was subsequently implanted with a pacemaker. The patient's vns therapy system was programmed to off prior to the pacemaker implant surgery and was programmed to on at certain points during the pacemaker implant surgery to assess whether the vns therapy affected the pacemaker sensing capabilities. When the pacemaker leads were implanted and connected to monitoring equipment, the vns therapy system was programmed to on at 1. 0ma output current. There were no changes to the monitoring equipment while the device was programmed to on at 1. 0ma output current. Normal mode output current was then increased from 1. 0ma to 2. 0ma with no changes to the monitoring equipment. Due to patient discomfort, the vns therapy system was programmed back to 0ma after approximately 10 seconds. The pacemaker battery was then implanted and connected to the pacemaker leads. The vns therapy system was then programmed to on at 3. 5ma normal mode output current in order to test the vns generator with the pacemaker and the pacemaker's monitoring equipment. After approximately 10 seconds, the vns therapy system was programmed back to off. Upon completion of the pacemaker implant surgery, the vns therapy system was interrogated to confirm that the device was programmed to off (0ma output current). Investigation to date has been unable to determine whether a relationship exists between the episodes of asystole and the vns therapy system. The patient's neurologist indicated that he was not aware of the patient having cardiac problems prior to the vns implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=566648
« Last Edit: July 26, 2013, 11:00:09 PM by dennis100 » Logged
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« Reply #27 on: June 13, 2011, 02:55:43 AM »

Event Date 04/01/2005
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Further follow-up revealed that the pt began to experience sinus bradycardia up to 40-50 beats per minute during sleep and was asymptomatic after stimulation was reinitiated. It was also reported that the pt had a pacemaker implanted due to the reported events. Neurologist indicated that the ncp system is possibly related to the reported events. It is likely that the ncp system contributed to the event. The reported accident/injury may have caused migration of the lead, resulting in affected the cardiac branch.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=601873


« Last Edit: July 26, 2013, 11:00:56 PM by dennis100 » Logged
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« Reply #28 on: June 16, 2011, 12:54:20 PM »

Event Date 03/18/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported by an unknown medtronic's representative that a patient's vagus never stimulator (vns) device was being explanted due to implantation of a pacemaker. Good faith attempts with patient's cardiologist regarding patient's cardiac issues have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2063785

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« Reply #29 on: June 16, 2011, 12:56:19 PM »

Event Date 03/21/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
On (b)(6) 2011, the manufacturer was called by a pacemaker company's representative requesting pacemaker precautions for a vns patient. The representative did not know what type of arrhythmia the patient is experiencing. The representative was informed of the pacemaker and electrocautery precautions for vns patients. Good faith attempts have been made to the patient's neurologist and cardiologist; however, no further information has been received. If additional information is gained, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2044885

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