Pages: [1] 2 3 ... 10
 1 
 on: November 09, 2019, 04:14:54 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/12/2019
Event Type  Injury   
Event Description
It was reported from the physician that patient is experiencing intermittent asystole episodes with cardiac pauses for 3-9 seconds. Physician who called is not the neurologist but is thinking the auto stimulation of vns is related to the cardiac events. The physician was told to contact the patient¿s neurologist to consult as to what is causing this event. It was reported that the patient is hospitalized due to having irregular heart patterns (bradycardia) events. The neurologist currently seeing him inpatient turned off the device as he wondered if bradycardia events would stop. Device was turned off for 6-8 hours and within that time there were 0 bradycardia events. When the device was turned back on the neurologist turned autostim off and lowered output current on normal and magnet. Within the following 6 hours of device being turned on there were one 2 bradycardia events. Patient does not have any underlying heart conditions. Provider does not know yet if he feels the vns stimulation is causing the bradycardia events. More testing will be completed. No additional information has been receive to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9162743

 2 
 on: November 09, 2019, 04:14:00 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2019
Event Type  Injury   
Event Description
Patient reported experiencing asystole and flatlining during knee surgery. The patient questioned if the device caused the event. Further information was received that the patient¿s cardiologist placed the patient on a 30-day heart monitor and discussed pacemaker placement. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9215702

 3 
 on: November 09, 2019, 04:11:55 AM 
Started by dennis100 - Last post by dennis100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/17/2019
Event Type  Injury   
Event Description
A hospital resident reported that a vns patient had presented with hypotension and bradycardia. It was noted that the physicians were hypothesizing if the vns was the source of the problem. The resident wanted to have the vns programmed off to see if the device is affecting the patient's condition. No further details were provided. Due to the hospitals policies, no further information could be obtained on this report. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9177777

 4 
 on: November 09, 2019, 04:10:59 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/12/2019
Event Type  Injury   
Event Description
It was reported from the physician that patient is experiencing intermittent asystole episodes with cardiac pauses for 3-9 seconds. Physician who called is not the neurologist but is thinking the auto stimulation of vns is related to the cardiac events. The physician was told to contact the patient¿s neurologist to consult as to what is causing this event. It was reported that the patient is hospitalized due to having irregular heart patterns (bradycardia) events. The neurologist currently seeing him inpatient turned off the device as he wondered if bradycardia events would stop. Device was turned off for 6-8 hours and within that time there were 0 bradycardia events. When the device was turned back on the neurologist turned autostim off and lowered output current on normal and magnet. Within the following 6 hours of device being turned on there were one 2 bradycardia events. Patient does not have any underlying heart conditions. Provider does not know yet if he feels the vns stimulation is causing the bradycardia events. More testing will be completed. No additional information has been receive to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9162743

 5 
 on: November 09, 2019, 04:10:07 AM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/06/2019
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was found prone and unresponsive, and was then taken to the er. A physician asked that a company representative come interrogate the patient's device to determine if any seizures had taken place, and they had found data showing that the patient had seizures all day long and had a period of bradycardia followed by more seizures and then another bradycardic period. At the point the patient was found and taken to the er. During the investigation for this patient it was determined through online obituary search the patient had passed away the day after the above events occurred. No additional information as to the cause of death or cause of the bradycardia/seizures has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9147314

 6 
 on: November 09, 2019, 04:09:07 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2019
Event Type  Injury   
Event Description
Patient reported to have been admitted to the emergency room with bradycardia. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9209826

 7 
 on: November 09, 2019, 04:08:20 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/16/2019
Event Type  Injury   
Event Description
It was reported by the hospitalist physician that the patient was in the hospital and was experiencing bradycardia. The cardiologist wanted vns to be turned off as a precautionary measure even though they did not necessarily think his vns was causing the bradycardia. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9166645

 8 
 on: November 09, 2019, 04:06:05 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/09/2019
Event Type  Injury   
Event Description
During the implant surgery for the patient, the generator was programmed on. Three diagnostic testes indicated that the device was functioning properly. The patient became bradycardic, as the neck and chest incisions were being closed. The patient's device was programmed off. The patient then went into asystole. Chest compressions were performed and the patient became stable. Soon after, diagnostics were performed again and indicated the device was functioning properly. The patients device was then programmed on and the patients was monitored for 24 hours with no further observed bradycardia and asystole. The physician indicated that they did not think vns was related to the bradycardia and asystole, but the cause of the event was unknown. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9157386

 9 
 on: November 09, 2019, 04:04:34 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2019
Event Type  Injury   
Event Description
Patient reported experiencing asystole and flatlining during knee surgery. The patient questioned if the device caused the event. Further information was received that the patient¿s cardiologist placed the patient on a 30-day heart monitor and discussed pacemaker placement. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9215702

 10 
 on: November 09, 2019, 04:00:12 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Device Problem High impedance
Event Date 09/13/2019
Event Type  Malfunction   
Manufacturer Narrative
Patient problem :3191; patient problem :1994; patient problem :3191; patient problem :2352; patient problem :2607; patient problem :1880; patient problem :1980.
 
Event Description
It was reported that a patient feels erratic stimulation and has a dcdc code indicating high impedance. The patient's pulse width was decreased in response. It was then reported that the patient was being referred for replacement due to low battery and "all the other stuff going on with the device". This is referring to the patient's reported adverse events of erratic stimulation and trouble breathing and talking when the device goes off. The physician reported that the dcdc code had been fluctuating. Additional adverse events were reported to be fluctuating and noted to be numbness in neck, ear pain, sinus pain, jaw pain, headaches, tingling, voice hoarseness, weight loss and heart issues. It was stated that when the patient disabled her device with the magnet, she reported having tingling, voice hoarseness, and a bit of headaches, but that all other symptoms mostly subside when the device is disabled. The patient stated that the breathing issues now are different than the ones from the past and that the patient has trouble catching her breath now and not just difficulty breathing. Further information was received that on a subsequent system diagnostic test with the patient's head facing forward and turned to the right, the patient has impedance within normal limits. Information was received that the patient's generator was replaced due to battery depletion and their lead was also replaced. The patient's lead has not been received by livanova to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9173459

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