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Author Topic: Intraoperative bradycardia/asystole  (Read 16625 times)
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dennis100
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« on: June 18, 2010, 10:11:23 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 03/03/2008
Event Type Injury Patient Outcome Other;
Event Description
Initial reporter indicated that during surgery to replace a pt's generator, the pt experienced five episodes of asystole. The events resolved spontaneously without intervention. The events corresponded to the generator on time. The generator was programmed off and the events resolved. The pt at their postop visit had the generator programmed onto a lower setting and did not have a reoccurrence of the asystole event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1021157
« Last Edit: May 14, 2014, 02:19:09 PM by dennis100 » Logged
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« Reply #1 on: June 18, 2010, 10:12:40 PM »

Event Date 01/19/1998
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Pt was being implanted with ncp sys model 100b. Lead test was performed per the physician's manual at which time pt experienced bradycardia. Event resolved when lead test was stopped. Second lead test was performed and pt again experienced bradycardia which resolved upon cessation of lead test. A third lead test resulted in asystole. Atropine was administered through the regular fluid line and approx six chest compressions were given. Pt recovered and was discharged from hosp with no further occurrences.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=145594
« Last Edit: July 27, 2013, 09:46:00 AM by dennis100 » Logged
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« Reply #2 on: June 18, 2010, 10:14:11 PM »

Event Date 04/18/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention .
Event Description
Reporter indicated that patient experienced a 7-8 second episode of asystole during intraoperative lead test. The asystole was resolved when the programming wand was pulled away from the generator. The surgeon was reportedly uncomfortable continuing with the implant and decided to explant the entire device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=461868
« Last Edit: July 27, 2013, 09:46:29 AM by dennis100 » Logged
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« Reply #3 on: June 18, 2010, 10:15:13 PM »

Event Date 05/22/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
During initial implant of ncp system, patient experienced asystole during intraoperative lead test. Duration was approximately 15 seconds. Atropine was administered and heart rate returned to normal. Stimulation was initiated at a lower setting (0. 25 ma) and no decrease in heart rate was noted. Stimulation was increased to 0. 5ma and no decrease in heart rate was noted. Stimulation was increased to 0. 75ma and heart rate decreased from 70 to 62 beats per minute. Stimulation was increased to 1ma and heart rate decreased from 70 to 64 beats per minute. A final lead test was performed prior to closing the patient and heart rate remained in 70's. Patient suffered no post-operative complications and was discharged to home with the device left off. Patient's device was activated two weeks post-operatively with no complications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=284523


« Last Edit: July 27, 2013, 09:47:14 AM by dennis100 » Logged
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« Reply #4 on: January 17, 2011, 11:11:05 AM »

Event Date 03/16/2000
Event Type Injury Patient Outcome Life Threatening;
Event Description
The epilepsy nurse specialist reported that following the ncp implant, the pt experienced asystole during the initial lead test. The lead test was attempted three times; each time the pt become asystolic. Following surgery, the pt was placed in the critical care unit and pt complainted of "severe chest pain every hour. " pt continued to experience asystole "every hour for approx 12 seconds. " the following morning, the epilepsy nurse specialist discovered that the generator had been activated in the operating room. Nurse immediately turned the device off and the pt's symptoms subsided. It is stated in the ncp system's physician's manual, under the precautions section, not to program the ncp system to an on or periodic stimulation treatment for at least 14 days after the initial or replacement implantation. The physician plans to reactivate the generator "in two weeks. " follow-up call from physician indicated that generator was activated on 3/30/2000 without incidents.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=273571

« Last Edit: July 27, 2013, 09:49:27 AM by dennis100 » Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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« Reply #5 on: January 18, 2011, 01:27:05 AM »

Event Date 11/25/1998
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Pt was being implanted with ncp pulse generator and bipolar lead on 11/25/98. Intraoperative diagnostic tests were performed in accordance with physician's manual. Per the physician's notes, loss of ventricular function was noted upon performance of lead test. The test was performed again, at which time the same loss of ventricular function was noted. An on-demand stimulation was initiated using the ncp magnet, which again resulted in loss of ventricular function. After the testing, pt recovered to normal sinus rhythm. Atropine (0. 6 mg) was administered. After the pt was without incident for approximately 15-20 minutes, the wounds were irrigated and closed. The pulse generator and bipolar lead were left in place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=215072



« Last Edit: July 27, 2013, 09:50:29 AM by dennis100 » Logged
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« Reply #6 on: January 18, 2011, 02:04:21 AM »

Event Date 07/18/1998
Event Type Injury Patient Outcome Life Threatening;
Event Description
On sept 18, 1998 an incident occurred in the operating room, which rptr feels should be brought to fda's attention. Pt is a 38-year-old male with a long-standing history of medically intractable seizures. Based on previous investigations and consensus agreement at a conference, the pt was deemed be a good candidate for implantation of vagal nerve stimulator. This is an fda approved device mfg by cyberonics, which has been demonstrated effective in the treatment of medically intractable partial seizures. The pt had been explained the risks and benefits of the procedure and had consented to surgery. The procedure was performed on friday, september 18, 1998 in the afternoon under general anesthetic. A left vagal nerve lead was placed over the vagus nerve, which had been clearly identified. Before connecting the generator to the lead, the vagal nerve generator had passed a routine diagnostic test. It was then attached to the vagal nerve lead, which was wrapped around the left vagus nerve. The lead test was then performed. This involves the generator stimulation of the vagus nerve. As soon as the lead test was commenced, the pt became asystolic. This test was aborted and the pt reverted to sinus rhythm. The duration of asystole was approximately 10 seconds. This was recorded by the anesthetist. Interrogation of the device was performed by the neurophysiologist of the dept of neurology. A nurse who was a rep of cyberonics was present at the time of the procedure. A backup generator was then connected to the vagal nerve lead. It's diagnostics as well were normal and when the lead test was performed, the pt's pulse did not change. The initial generator then underwent a repeat diagnostic test, which again revealed the generator to be normal. A lead test with the original generator was then repeated. The pt again became briefly asystolic. This test was immediately aborted. At this point, a decision was made not to implant a stimulator in this pt given the unk etiology of this arrhythmia. The vagal nerve lead was then removed from the vagus nerve. The device was then put under the care of a dr, the dept of neurology and the nurse rep from the cyberonic's co. The operative field was irrigated and closed. General endotracheal anesthesia was reversed and the pt was examined and found to be neurologically normal. His vital signs were stable. He was maintained in a monitored setting overnight and was seen in consultation by an attending cardiologist, who concluded that his heart was normal. A full or incident report was filed and submitted to the operating room. Rptr has filed an oral report with the food and drug administration. As well, rptr has contacted cyberonics concerning this incident and questioning implantation of the vagal nerve stimulator device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=188325


« Last Edit: July 27, 2013, 09:53:00 AM by dennis100 » Logged
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« Reply #7 on: January 18, 2011, 02:44:59 AM »

Event Date 09/18/1998
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Pt was being implanted with ncp system pulse generator model 100b. Lead test, performed physician's manual, resulted in an asystole event that lasted approximately 10 seconds. Upon completion of the lead test, the pt's heart rate returned to normal without medical intervention. Physician believed that the event may have been related to a device malfuntion; therefore, a backup pulse generator was opened and interrogated without incident. The backup pulse generator was then connected to the lead and another lead test was performed; no asystole occurred. Original generator was then reconnected, lead test performed, asystole reoccurred. Decision was made that no device implantation should occur.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=191850


« Last Edit: July 27, 2013, 09:54:05 AM by dennis100 » Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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« Reply #8 on: January 18, 2011, 03:15:16 AM »

Event Date 09/09/1998
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Pt was being implanted with ncp system pulse generator model 100b. Lead test was performed per the physician's manual. Pt experienced asystole which lasted approximately 6 seconds. No medical intervention was taken and the pt's heart rate returned to normal. A second lead test was performed which again resulted in asystole. This event lasted approximately 15 seconds. The resident anesthesiologist administered epinephrine at the same time the pt was recovering. The device was not implanted. Physician noted that the pt's vagus nerve was unusually deep and the nerve anatomy was abnormal. Pt was discharged without injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=191453

« Last Edit: July 27, 2013, 09:55:03 AM by dennis100 » Logged
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« Reply #9 on: January 18, 2011, 09:24:17 AM »

Event Date 03/30/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt experienced bradycardia during first lead test (rate of 74) and a first degree block (a pause between the atria and the ventricle conduction). The dc/dc code was 1. On the second lead test there was a second degree block (atria contracted but the ventricle didn't) for 10 seconds. This spontaneously resolved and the rate was back to approx 60. No intervention was taken. The dc/dc code of the second lead test was 1.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=329263

« Last Edit: July 27, 2013, 09:56:22 AM by dennis100 » Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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« Reply #10 on: January 18, 2011, 09:59:52 AM »

Event Date 03/14/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the physician left the generator and lead implanted, but did not attach the lead to the nerve and did not initiate stimulation. The physician planned to re-position the same devices on the right side 3 weeks later. At the time that the device re-positioning was attempted, the pt had developed an infection at the generator site. Both the generator and the lead were explanted. The lead was discarded and will not be returned for analysis. It was reported that the pt has completely recovered. No re-implant is scheduled at this time. Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies or abnormalities that would have an adverse efect on device performance. Sterlilization was confirmed for both devices.

Event Description
Reporter indicated that pt experienced asystole during lead test.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=327059

« Last Edit: July 13, 2011, 11:06:27 PM by dennis100 » Logged

VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

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« Reply #11 on: January 18, 2011, 06:55:48 PM »

Event Date 01/16/2001
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
Physician reported that pt experienced 4 - 5 seconds of total asystole. No intervention was performed. The device was interrogated after the event and the output current was 0. 0 ma. The physician ramped the pt up from 0. 25 to 1. 0 ma in 0. 25 ma steps with a 7 second on time and 250 usec pulse width at 20 hz and no further asystole event occurred. The output current for the device was set to 0. 0 ma and the pt will be ramped up in 2 weeks. A cardiac assessment will be made at that time.

Event Description
Asystole observed during lead test at surgical implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=316364
 
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« Reply #12 on: January 18, 2011, 11:50:45 PM »

Event Date 07/11/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Physician had to abandon a vagus nerve stimulator implant because of marked bradycardia amounting to asystole on lead testing. This occurred consistently at the same point in the lead test sequence on two occasions. The device was removed. Pt has made a good recovery with no further evidence of any cardiac irregularity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=312874

« Last Edit: July 27, 2013, 09:59:17 AM by dennis100 » Logged

VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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« Reply #13 on: January 22, 2011, 12:14:10 AM »

Event Date 12/12/2000
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
During intraoperative lead test, a very short episode of asystole/bradycardia was reported. After a massage of the thorax by the nurse, the rhythm of the heart became normal again. No use of cardiotonic. Device was turned off and implantation surgery completed with no more lead tests performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=312285

« Last Edit: July 27, 2013, 10:00:08 AM by dennis100 » Logged
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« Reply #14 on: January 22, 2011, 07:49:37 AM »

Event Date 11/30/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that the patient had asystole for 2-3 seconds during the first lead test at implant surgery. Pt's heart rate was back up to 58 before the lead test finished. The dc-dc code was 2, indicating proper device function. During the second lead test, the patient's heart rate dropped to 28 and back to 60 before the lead test was finished. The dc-dc code was 1 on the second lead test, again indicating proper device function. The patient's resting heart rate was 68. The implant procedure was completed without further incident. Patient was seen for follow up visit in 12/01. The device has not yet been programmed to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=368376

« Last Edit: July 27, 2013, 10:01:09 AM by dennis100 » Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
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« Reply #15 on: January 22, 2011, 08:17:11 AM »

Event Date 09/12/2001
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that during vns implant procedure, first lead test resulted in asystole. Approximately 12 seconds later, wand was removed from device and 0. 4 mg atropine iv was administered. Approximately 5 seconds after administration of atropine, heart rhythm returned to sb, then sr, then st to heart rate of 128. Heart rate then decreased to 88 (baseline of 50). Device was interrogated and output current found to be at 1. 0 ma. Device was programmed to off. Ten minutes later, 2nd lead test was conducted with no bradycardia or asystole. 3rd lead test was conducted at closing with no bradycardia or asystole. Device was later programmed to on without incident in 2001.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=356366


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« Reply #16 on: January 23, 2011, 09:34:23 AM »

Event Date 06/06/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
Rptr indicated that following the implant, the pt experienced a 5 second episode of asystole that spontaneously resolved. The pt recovered with no further complications. The device was activated two days post-implant with no adverse events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=342957

« Last Edit: July 27, 2013, 10:03:01 AM by dennis100 » Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
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« Reply #17 on: January 24, 2011, 10:55:15 AM »

Event Date 08/08/2001
Event Type Injury Patient Outcome Life Threatening; .
Event Description
Initial reporter indicated that the patient experienced severe bradycardia during first intraoperative lead test. The lead test was repeated and resulted again with bradycardia, but only for 20 seconds. Further investigation revealed that the device was programmed on only for 15 minutes without any problems and during the first led test, the heart rate was 40 and asystole was seen for 10 seconds. Late report due to administrative error.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=352059
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« Reply #18 on: March 08, 2011, 09:29:35 PM »

Event Date 04/02/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Rptr indicated that pt experienced bradycardia during lead test at implant surgery. Medication was administered and the procedure was completed without further incident. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=394937

« Last Edit: July 27, 2013, 10:04:45 AM by dennis100 » Logged
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« Reply #19 on: March 08, 2011, 11:07:27 PM »

Event Date 09/26/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt experienced an episode of bradycardia during lead test at vns implant surgery. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=392924


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« Reply #20 on: April 08, 2011, 07:56:57 AM »

Event Date 03/14/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt experienced an episode of bradycardia when lead test was run during implant surgery (ca 25/min for several seconds). Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=388419

« Last Edit: July 27, 2013, 10:05:32 AM by dennis100 » Logged
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« Reply #21 on: May 05, 2011, 03:44:06 AM »

Event Date 02/08/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that the patient experienced a 3-6 second episode of asystole during the first lead test at implant. It was reported that the surgeon had difficulties dissecting out the vagus and placing the lead on the nerve. This took over two hours and it was reported that the surgeon normally completes this in about 45 minutes. Near the end of the lead test the patient's heart rate dropped to the 50's then patient had a 3-6 second episode of asystole. It was reported that the programming wand was removed during the lead test, but the device was re-interrogated to ensure that it was not programmed to on, which it was not. Atropine was given by the anesthesiologist eventhough the patient's heart rate was returning rapidly to the baseline. The surgeon elected to continue with the replacement, but not run another lead test. The surgery proceeded with no further problems. Further follow-up revealed that the patient returned to work 3 days after the implant surgery with only minimal hoarseness present and is doing wonderfully. Physician plans to program the device to on. Attempts to obtain additional information have been unsuccessful to date. The physician will not release medical records due to patient confidentiality.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=381876

« Last Edit: July 27, 2013, 10:07:07 AM by dennis100 » Logged
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« Reply #22 on: May 05, 2011, 03:44:52 AM »

Event Date 10/21/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt experienced an episode of asystole during intra-operative lead test that lasted for 10 seconds. The pt does not have any pre-existing cardiac conditions. The implant procedure was completed without further incident and the device has not yet been programmed to on. It was reported that the pt is in stable condition. It is not known at this time whether the lead electrodes are placed on either the superior or the inferior cervical cardiac branches, which could cause or contribute to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=429431

« Last Edit: July 27, 2013, 10:07:57 AM by dennis100 » Logged
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« Reply #23 on: May 28, 2011, 02:40:57 AM »

Event Date 10/15/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that patient experienced an episode of asystole when lead test was performed during inplant surgery. Twenty seconds into the lead test, the patient went from a heart rate of 60-65 bpm to flate line asystole. The programming wand was removed from the patient's generator approximately 5 seconds after the confirmation of the ekg leads. After removal of the wand, the patient regained normal rhythm. The implant surgery was completed without further cardiac incident. The patient's ncp system has not yet been programmed to on. The implanting surgeon confirmed that the lead coils were placed on the vagus trunk, but could not recall the proximity to the inferior vagus nerve branch.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=428032


« Last Edit: July 27, 2013, 10:08:52 AM by dennis100 » Logged
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« Reply #24 on: June 09, 2011, 01:12:13 AM »

Event Date 09/09/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt experienced an 8-second episode of asystole during lead diagnostic testing at vns implant surgery. The test was run twice and the pt had asystole both times. The first period asystole was shorter than the second period of asystole. The ncp system was not implanted in the pt. The pt was reported to be doing fine and has not had any cardiac events post-surgery. It is not known whether the pt has previous cardiac history or whether the lead electrodes may have been placed on either the superior or the inferior cervical cardiac branches, which could contribute to the episode of asystole.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=422011

« Last Edit: July 27, 2013, 10:09:46 AM by dennis100 » Logged
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« Reply #25 on: July 13, 2011, 11:23:29 PM »

Event Date 08/08/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention .
Event Description
Reporter indicated that patient experienced two episodes of bradycardia (heart rate 20 bpm) during lead test at implant surgery. The surgeon re-evaluated the lead placement to ensure that the electrodes were below the superior and inferior cardiac branches of the vagus nerve. The lead was moved down on the vagus nerve and another lead test was performed with no cardiac episode. The patient has been seen for post-operative visit and is reportedly doing well. Physician plans follow-up with patient on an "as needed" basis only. Attempts to obtain additional information have been unsuccessful to date. A letter requesting additional information was sent to both the neurologist and the surgeon via u. S. Mail and via fax with no response to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=415253

« Last Edit: July 27, 2013, 10:10:55 AM by dennis100 » Logged
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« Reply #26 on: July 13, 2011, 11:24:02 PM »

Event Date 06/14/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient experienced two episodes of asystole during implant surgery. During the first lead test, the patient experienced an episode of asystole lasting a few seconds. The lead test results showed high impedance. The surgeon checked the generator/lead connection and ran another lead test. The patient again experienced a brief episode of asystole. This time the lead test results were fault/fault. The surgeon re-booted the computer and ran a third lead test. This time the results were ok and no asystole was experienced. Two additional lead tests were run, both with ok results and no asystole. The surgeon felt comfortable with the device implanted. The patient's device would be programmed to on at a later date by pt's neurologist. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=404894

« Last Edit: July 27, 2013, 10:12:20 AM by dennis100 » Logged
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« Reply #27 on: July 13, 2011, 11:25:21 PM »

Event Date 06/03/2002
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt experienced an episode of asystole when normal mode diagnostic test was performed during implant surgery. Lead test performed prior to asystolic episode without incident. As a normal practice, the surgeon programs the device to 2. 0ma, 30hz, 500pw, 30 seconds on, and 5 mins off and runs a normal mode diagnostic test. It was during this normal mode test that the episode of asystole occurred. The surgeon then decreased the output current to 0. 25ma and ran another normal mode test. Afterward, the device was programmed to 0ma output current. The pt is reportedly doing fine post-operatively. The pt's device has not yet been programmed to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=403648


« Last Edit: July 27, 2013, 10:13:43 AM by dennis100 » Logged
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« Reply #28 on: July 13, 2011, 11:26:15 PM »

Event Date 05/31/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
The reporter indicated that the pt experienced bradycardia and asystole in the or during the initial lead test. The device was not implanted. The pulse generator and bipolar lead were discarded by the materials clerk at the hosp. Two attempts (one in writing and one via phone) to obtain more info regarding this event have been made; however, no info has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=402640

« Last Edit: July 27, 2013, 10:14:06 AM by dennis100 » Logged
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« Reply #29 on: July 13, 2011, 11:26:53 PM »

Event Date 04/30/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention .
Event Description
Reporter indicated that initial implant surgery was aborted due to two episodes of complete av block that occurred during the lead tests. The first episode was approximately 4-6 seconds in duration and resolved without intervention. The second episode lasted approximately 6-8 seconds and did not resolve after atropine was administered. It was reported that the patient's baseline heart rate was 50-60. Both episodes of the av block had p-waves present with no qrs complex per ekg. The patient was kept in the hospital overnight for observation and did not have any other ectopy or heart blocks. The patient has not been seen by neurosurgeon since the event as patient lives in a different city. Investigation to date has been unable to determine whether the patient had previous cardiac history.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=462953

« Last Edit: July 27, 2013, 10:14:52 AM by dennis100 » Logged
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