Pages: [1] 2 3 ... 10
 1 
 on: September 07, 2019, 03:01:31 AM 
Started by dennis100 - Last post by dennis100
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2019
Event Type  Injury   
Event Description
It was reported that a patient is experiencing bradycardia and the patient's physician requested further data or literature on bradycardia and vns therapy. The physician does not know at this time whether the bradycardia is related to the vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8885003

 2 
 on: September 07, 2019, 02:59:59 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Device Problem Appropriate Term/Code Not Available
Event Date 07/11/2019
Event Type  Malfunction   
Event Description
Patient underwent defibrillation and reported experiencing a chocking sensation and painful stimulation/shocking following the event. Per the patient's neurology office, the lead wire was fried. The device was disabled. It was noted that the cardioversion had burned the vns wire and that the patient was referred for device replacement. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8885889

 3 
 on: September 07, 2019, 02:59:18 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a cardiologist that a vns patient was experiencing syncope and her blood pressure was stated be "bottoming out". The physician stated that when the patient stands up or lies down, they have a spell intermittently which drops their blood pressure from 180/100 to 100/80. The physician desired the vns to be disabled to see if the adverse events were related to stimulation. Further information was received that the patient is having severe side effects, specifically uncomfortable twitching at the generator site, slowing heart rate, and dropping blood pressure. It was stated that when the generator was disabled with the magnet, the adverse events ceased. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes stated that the patient is having issues with her vns misfiring, and states that she has been experiencing low blood pressure, syncope episodes. The cardiologist advised to have the vns turned off. The patient has experienced several seizures since having the vns disabled by the magnet but the disablement has lessened the patient's syncope episodes. The cardiologist does not believe that her symptoms are coming from her heart but the vns unit. It was stated that the vns has been disabled at this time. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8884891

 4 
 on: September 07, 2019, 02:51:34 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a cardiologist that a vns patient was experiencing syncope and her blood pressure was stated be "bottoming out". The physician stated that when the patient stands up or lies down, they have a spell intermittently which drops their blood pressure from 180/100 to 100/80. The physician desired the vns to be disabled to see if the adverse events were related to stimulation. Further information was received that the patient is having severe side effects, specifically uncomfortable twitching at the generator site, slowing heart rate, and dropping blood pressure. It was stated that when the generator was disabled with the magnet, the adverse events ceased. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes stated that the patient is having issues with her vns misfiring, and states that she has been experiencing low blood pressure, syncope episodes. The cardiologist advised to have the vns turned off. The patient has experienced several seizures since having the vns disabled by the magnet but the disablement has lessened the patient's syncope episodes. The cardiologist does not believe that her symptoms are coming from her heart but the vns unit. It was stated that the vns has been disabled at this time. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8884891

 5 
 on: September 07, 2019, 02:50:54 AM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced dizziness ever since the vns was programmed on and that the dizziness increased when the output current was increased. The patient reported that dizziness was present when standing and subsides when she lays/sits down. It was stated that the dizziness is constant when she stands. The physician reported that the patient has had dizziness in the past due to previously prescribed aeds prior to implant. However, no medications have been changed since vns implantation. The physician lowered the output current from 1. 25 ma to 0. 75 ma and the adverse event did not resolve. The physician disabled the vns in order to determine if the issue resolved. Follow up with the physician's office revealed that they had disabled the "scheduled doses" and that the patient could only manually stimulate, which was confirmed to mean that only magnet mode was programmed on. The physician stated that it was believed that the main component of the dizziness was due to anxiety. Diagnostics were within normal limits. It was later reported by the patient¿s daughter that the patient was referred for vns explant surgery in (b)(6) 2019. It was stated that the vns was ¿triggering epilepsy for the patient¿ and they wanted to move up the surgery date. The daughter later reported that the patient was experiencing dizziness, ambulation difficulties (disbalance), headaches, and a lack of energy. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8927290

 6 
 on: September 07, 2019, 02:50:11 AM 
Started by dennis100 - Last post by dennis100
Model Number 7103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/21/2019
Event Type  Injury   
Event Description
It was reported from a clinical study that a patient is experiencing an event of syncope that is possibly related to stimulation. The event is possibly related to underlying disease. Subject had this happen before when he was started on entresto. Had a syncopal episode. The physician had discontinued and this had not happened again until now. Considered not related to study procedure. The outcome is recovered/resolved. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8922527

 7 
 on: September 07, 2019, 02:48:07 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing swallowing difficulties, dyspnea, and pain during stimulation. The swallowing difficulties started on the day after implant and were reported as mild and probably related to the implant/procedure. Medication was provided to the patient as a result. The dyspnea started on the same day and was reported as mild and as having a casual relationship to both the implant/procedure and stimulation/device. No intervention was noted other than sending the patient to neurosurgery and an ent for evaluation. The painful stimulation was reported as beginning several months later and being mild with a casual relationship to both the implant/procedure and stimulation/device. The patient's therapy was modified as a result. Follow up with the company representatives revealed that during a logopedic examination, examination with endoscopy revealed that the patient has a slight vagus nerve paresis, which is attributed to the implant surgery. It was stated that the painful stimulation had spread to the larynx and it was questioned if the paresis was responsible for the pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8949175

 8 
 on: September 07, 2019, 02:47:23 AM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/20/2019
Event Type  Injury   
Event Description
It was reported by the patient's sister that they recently received a generator replacement and since then the patient has lost their voice completely, has not been able to communicate, and has difficulty breathing. The patient's settings were turned down to relieve the symptoms but there has been no success and the device has now been turned off a week. The patient has still not been able to speak and easily becomes short of breath. Additional information was received during follow-up with the physician's office by the nurse indicating they are still in the process of trying to determine if the patient has vocal cord paralysis. No surgical intervention regarding the reported event has known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8896961

 9 
 on: September 07, 2019, 02:45:20 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/08/2019
Event Type  Injury   
Event Description
The physician reported that a patient was having therapy related pain. There was no high lead impedance, and per the physician the patient's x-ray looked normal; however, the physician still believed that there may be something wrong with the generator. The sales representative visited the patient in the hospital to check the device. The sales representative reported that the system diagnostics were within normal limits. Clinic notes were later received confirming that the patient had been referred for generator/lead revision to upgrade to a m1000 sentiva generator. The clinic notes were reviewed and mentioned that the patient continues to have intermittent chest pains. The physician noted that the plan for the reported pain was to refer the patient to the surgeon for replacement. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8855009

 10 
 on: September 07, 2019, 02:44:03 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2019
Event Type  Malfunction   
Event Description
It was reported by the case manager that the patient reported having chest pain, seizures and magnet was not working. Attempts were made to obtain further information from the patient and who the following neurologist, however no response has been received to date. Since current neurologist is unknown, no further attempts for information can be made. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8854951

Pages: [1] 2 3 ... 10