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Author Topic: Cardiac Arrest  (Read 11910 times)
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dennis100
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« Reply #120 on: October 29, 2018, 11:27:24 AM »

Model Number 103
Event Date 09/06/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a physician that the patient was experiencing bradycardia while monitored telemetry machine. The bradycardia was occurring every 1. 8minutes. The magnet was taped over the device and left for twelve hours. Upon removal of the magnet, the patient experience asystole. The heart rhythm was regained when the magnet was placed back over the device. Attempts for additional information are in progress.
 
Event Description
It was reported that the patient's output current was titrated down, and eventually reached a level where the patient was no longer experiencing bradycardia.
 
Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2772615
« Last Edit: October 30, 2018, 01:23:03 AM by dennis100 » Logged
dennis100
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« Reply #121 on: October 30, 2018, 01:23:41 AM »

Model Number 102R
Event Date 04/21/2008
Event Type  Death   
Event Description
Reporter indicated a vns patient died after cardiac arrest. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1054327
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dennis100
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« Reply #122 on: November 06, 2018, 07:55:38 AM »

Model Number 103
Event Date 07/22/2013
Event Type  Injury   
Event Description
It was reported that the patient needed a pacmaker placed.
 
Event Description
It was reported that the patient underwent a 24-hour holter monitoring due to dizziness. During the monitoring it was discovered that the patient had forty-five nine-second cardiac pauses that only occurred during the patient¿s sleep. It is unknown if the event corresponded with device stimulation. The patient was seen by neurologist and device settings were lowered. The neurologist was unsure if the cardiac pauses were related to vns therapy and referred the patient to a cardiologist. The holter monitor was repeated at the lower settings at which time the patient was noted to be asymptomatic. The cardiologist believed that since the events did not recur at the lower settings that the cardiac pauses were related to vns therapy; however, the cardiologist¿s partner, an electrophysiologist, believes that the cardiac pauses are a result of an underlying condition. It was reported that the electrophysiologist wants to run further testing to determine the relationship when the settings are adjusted. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
It was reported that the patient underwent implant of a pacemaker on (b)(6) 2013. It was reported that the patient has not been seen by the neurologist since being implanted with the pacemaker.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3301472
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dennis100
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« Reply #123 on: November 09, 2018, 03:22:49 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient is experiencing asystole when the magnet is activated for 15 seconds after the magnet swipe. The patient is reported to be diagnosed with aortic stenosis and rheumatic heart disease. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7980947
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dennis100
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« Reply #124 on: November 13, 2018, 07:27:45 AM »

Model Number 102
Event Date 08/01/2011
Event Type  Injury   
Event Description
It was initially reported that patient had been having recent arrhythmia events. She had been having some atrial fibrillation, which was being treated with medication. Then the patient began having asystole events that last about 6 seconds and well as some bradycardia. The patient had an emergency pacemaker placed and then underwent surgery to have a pacemaker implanted. The relationship of the cardiac events to vns is unknown. Good faith attempt with both the neurologist and the cardiologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2261210
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dennis100
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« Reply #125 on: November 22, 2018, 03:10:45 AM »

Event Date 01/01/2008
Event Type  Injury   
Event Description
Reporter indicated that an asystole event had occurred. No other information is available at this time. All attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1222464
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dennis100
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« Reply #126 on: December 12, 2018, 02:40:45 AM »

Model Number 103
Event Date 08/23/2013
Event Type  Injury   
Event Description
Additional information was received from the neurologist stating that the patient¿s bradycardia was possibly related to vns. The patient¿s device was programmed off. The patient did not have a medical history of bradycardia prior to vns.

Manufacturer Narrative

Event Description
It was reported that the vns patient has been in the hospital icu with bradycardia and has coded at least once. A company representative went to the hospital to perform device diagnostics which were reported to be within normal limits. It was reported that the patient underwent cardiac workup and that the cardiologist found only vns as a potential source of the bradycardia. It was reported that the arrythmia events are not occurring with stimulation and they occur infrequently; however, the patient has had to be revived once or twice. The neurologist decreased the output current from 2. 5ma to 1. 5ma and is going to evaluate the patient to see if that helps. It was reported that there were no setting changes or medication changes that preceded the onset of the bradycardia. The patient's mother reported that the patient did not have any prior history of cardiac events.

Manufacturer Narrative
Date of event, corrected data: the initial manufacturer report incorrectly reported the date of the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3363303
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dennis100
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« Reply #127 on: January 05, 2019, 04:19:18 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/15/2018
Event Type  Injury   
Event Description
It was reported that after a patient's device settings were programmed on after a prophylactic replacement surgery, the patient experienced bradycardia and asystole with stimulation. The event occurred twice during normal mode therapy stimulation. Settings were lowered to output current of 0. 5ma and these events resolved. Diagnostics indicated that the device was functioning within normal limits. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8142970
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dennis100
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« Reply #128 on: January 05, 2019, 04:20:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/10/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient passed out. Upon following up with the doctor on the event the same day, the patient's heart rate was monitored, and when the patient swiped their vns magnet an asystole event occurred. During normal mode stimulations of the generator the patient experienced a rapid drop in heart rate, from resting 111bpm to 40bpm during stimulation. It was additionally reported, a few days after the asystole event, that the physician tried to program the generator back to previous settings, but the patient could not tolerate any output current due to coughing fits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8135645
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dennis100
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« Reply #129 on: February 08, 2019, 07:49:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/14/2018
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient underwent vns implantation surgery a few months previously. Three weeks prior to the initial report, the generator was programmed on. The patient passed away and the cause of death was unknown at the time of the initial report. The physicians did not believe it was related to vns, but the patient's supervisor believed the vns caused the death and the event was being investigated by the police as a result. Follow up with the company representative area revealed that the patient¿s mother found the patient with asystole four days prior to the patient's death. Brain death was diagnosed. The physician believed that the cause of death was sudep. This was provided to the company representative by the police officer investigating the death. An epileptology expert, the police officer, and the company representative were to interrogate the explanted generator. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8241047
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dennis100
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« Reply #130 on: March 08, 2019, 02:26:53 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that a patient had experienced vns magnet-induced asystole. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8371729
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dennis100
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« Reply #131 on: April 06, 2019, 02:58:21 AM »

Model Number 106
Device Problem Insufficient Information
Event Date 03/12/2019
Event Type  Malfunction   
Event Description
It was reported that a patient went into cardiac arrest and was admitted to the hospital. No details were provided on what occurred except that the patient was intubated. The physician was concerned that the patient's vns may have been damaged during the code process. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8458803
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dennis100
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« Reply #132 on: April 08, 2019, 03:31:06 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the hospital due to an unspecified cardiac issue. Information was later received from the patient¿s mother that the patient¿s settings were changed earlier that week and clarified that the patient was hospitalized due to bad seizures which resulted in the patient¿s heart stopping. The patient¿s mother also reported that the physicians could not determine the cause of the heart issues during the hospitalization. Follow up with the patient¿s mother determined that the physician checked the patient¿s vns after the hospitalization and stated battery life and impedance were ok. Additionally, follow up with the physician¿s nurse practitioner was performed determined that the patient¿s device was slightly ¿turned down¿ after the hospitalization. The event was discussed with the neurologist, and the neurologist expressed that he could not determine the cause of the heart issues. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8390226
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dennis100
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« Reply #133 on: May 10, 2019, 02:42:36 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Event Description
It was reported that the patient was implanted with vns to treat depression, and that the patient experienced a cardiac arrest at the end of a surgery in november 2018. Per the reporter, the patient¿s battery has been dead for some amount of years. There was no indication the surgery was associated with vns; however, a concern was expressed that the cardiac arrest may be associated with the lead remaining attached to the vagus nerve. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8556175
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dennis100
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« Reply #134 on: June 28, 2019, 11:37:38 PM »

Model Number 101
Event Date 05/01/2006
Event Type  Injury   
Manufacturer Narrative
Results - (b) (4) system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Conclusions - treating physician indicates that the reported events appear to be related to device stimulation; however, the physician does not know why the pt began to experience these events after more than six years of successful vns therapy.
 
Event Description
Reporter indicated that pt began to experience episodes of syncope and asystole approximately six years post vns implant. The pt reported feeling the need to cough, after which he reportedly lost consciousness. Approximately two months after, the onset of symptoms, the pt was hospitalized for eval of the syncope episodes, at which time and ekg revealed episodes of asystole that coincided with device stimulation cycles; however, not every stimulation cycle would produce this event. The vns therapy system was then programmed to off, after which a repeat ekg was normal. The pt did not experience any further episodes of syncope or asystole in the absence of the vns therapy. Eval by cardiologist did not reveal any abnormalities with the pt's heart. The device remains programmed to off. Both the cardiologist and the neurologist believe that the reported events were caused by the stimulation of the vagus nerve. There had been no recent changes to programmed device settings; however, inderal had recently been added to the pt's medication regimen for treatment of mild hypertension.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1629932
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dennis100
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« Reply #135 on: July 02, 2019, 01:38:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/21/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient had a prophylactic full revision surgery and experienced post-operative bradycardia that appeared to be a result of stimulation on times. The surgeon programmed the device off. There were no issues observed during the surgery or intraoperative bradycardia. The impedance during the surgery was within normal limits. No further relevant information has been received to date.
 
Event Description
Further details were received regarding the arrhythmia after vns surgery. The patient did not have a history of cardiac events or any other comorbidities listed. The medications provided to the patient during surgery were not available. The patient did request that she not have general anesthesia, but it was unknown if the patient had a previous reaction to general anesthesia in the past. The surgeon was not comfortable doing the surgery with only local anesthesia, so a full general was performed. The surgeon identified extensive scarring at the electrode site, which was attributed to the implant procedure, and the old electrodes were not removed from the nerve. The new electrodes were implanted above the old electrodes on the vagus nerve. The new device was set to the same settings as the previous generator, per the surgeon's instruction. The surgery was 1. 5 hrs long, which was not considered to be a long surgery due to the full revision. The patient was fine during surgery when system diagnostics were performed. After surgery, the patient experienced asystole during stimulation along with significant coughing. Once the device was programmed off, the asystole and coughing did not occur again. The patient's device was programmed on by the neurologist. The patient did not experience any side effects at these settings, and titration was planned as normal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7445894
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dennis100
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« Reply #136 on: July 06, 2019, 12:21:33 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8684960
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« Reply #137 on: July 06, 2019, 12:22:23 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/16/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient went to the er with a syncopal episode/ possible asystole episode two days post prophylactic battery change. The new generator had been programmed to the same settings as the old generator. The physician didn't believe this event was related to vns but planned to turn output down. It was later noted that asystole occurred when the magnet was removed from the generator. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8685317
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dennis100
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« Reply #138 on: July 23, 2019, 01:32:07 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/03/2018
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing breakthrough seizures for which the patient was hospitalized for further care. The level of medication compliance was stated to be unknown at that time. The patient subsequently suffered a severe cardiac arrest not long after which was secondary to a generalized convulsion. The patient was admitted to a local hospital and were then reportedly placed on burst suppression, intubated and sedated. A short time after this the family decided to withdraw care and allow the patient to pass. Per a company representative, the neurologist did not believe the death was caused by vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8332309
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« Reply #139 on: July 23, 2019, 01:33:09 AM »

Model Number 1000
Event Date 10/18/2018
Event Type  Death   
Event Description
Reporter states her son had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours as his rhythm was stop and go. He was pronounced dead at 11am. A few weeks prior to this event, the pt had an mri done, in which his vns was turned off and the on again by a different neurologist. After the exam, the vns would constantly turn on and off on its own and started to affect his vocal cords. Her son mention he believed the neurologist may have turned the vns up too high and he wanted to have it explanted. She reports the device wasn't helping him and his seizures were getting worse, increasing to 6 violent episodes a month. She also notes her son was agitated and had horrible heartburn the day before he died which literally "knocked him forward. " the autopsy came back negative for any abnormal tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8155362
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dennis100
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« Reply #140 on: July 30, 2019, 11:05:38 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/27/2019
Event Type  Death   
Event Description
It was reported that the patient had a seizure and vomited. It was reported that the patient's second vns magnet swipe brought the patient out of the seizure but then the patient had another seizure, vomited, arrested and the ems attempted to administer epi but the patient passed away. The patient had a history of vomiting with seizures prior to their vns implant. The patient's neurologist indicated that the cause of death was unknown and that they did not believe the vns to be the cause of death. Clinic notes indicated that there were registered auto-stimulations. The return of the suspect product is not expected to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8466837
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« Reply #141 on: July 30, 2019, 11:06:09 AM »

Model Number 104
Event Date 05/20/2011
Event Type  Injury   
Event Description
It was reported by a nurse at the hosp epilepsy monitoring unit that the pt "has asystole, and not seizures" and want to remove the pt's vns and implant a pacemaker. It is unk if there is any relationship between the asystole and the vns. The vns was reportedly disabled and it is unk if the vns generator and/or lead have been explanted at this time. Attempts for further info have been unsuccessful to date. Attempts to the pt's previous neurologist found that he has not been seen in some time and no longer sees that physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2139241
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dennis100
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« Reply #142 on: August 10, 2019, 03:51:11 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8842887
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