Pages: 1 2 [3] 4 5 ... 10
 21 
 on: August 10, 2019, 03:11:42 AM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient experienced an increase in drop seizures since vns implant surgery. It was reported that the patient was having up to 500 per day and that the drop seizures were well controlled prior to surgery. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8762936

 22 
 on: August 10, 2019, 03:11:06 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2019
Event Type  Malfunction   
Event Description
It was reported that the patient experienced an increase in seizure activity. The physician believed the patient would benefit from a dosing change as he felt the vns "wasn't working as well as it should, since the patient was now having additional seizures. " multiple attempts were made to obtain the physician's assessment regarding the reported increase in seizure activity; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8753199

 23 
 on: August 10, 2019, 03:10:27 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/06/2019
Event Type  Injury   
Event Description
The patient reported that they experienced stronger seizures than normal. The patient also believed that their seizure frequency had increased; and a representative reported that the patient had three seizures while in the patient room. Multiple attempts for additional information were made to the patient's following neurologist; however, no further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8751322

 24 
 on: August 10, 2019, 03:09:51 AM 
Started by dennis100 - Last post by dennis100
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/12/2019
Event Type  Malfunction   
Event Description
Patient reported experiencing an increase in seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764200

 25 
 on: August 10, 2019, 03:09:14 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported by the patient's father that when the patient's autostimulation was raised to 2. 5 ma, the patient started having more seizures. As a result, the patient's autostimulation output current was programmed back down to 2. 25 ma. The physician's office reported that the patient had reported to them that when the autostimulation was turned higher, they had more seizures. The patient also reported that the seizures returned t normal after the autostimulation was turned back down to 2. 25 ma. The physician reported that diagnostics were okay and that the family didn't report any external contributing factors. The office was unsure whether the increased seizure rate at the higher autostimulation output current was better than pre-vns levels. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8833242

 26 
 on: August 10, 2019, 03:08:39 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2019
Event Type  Malfunction   
Event Description
It was reported that a patient is having an increase in seizures in the last month. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8798610

 27 
 on: August 10, 2019, 03:08:04 AM 
Started by dennis100 - Last post by dennis100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2019
Event Type  Injury   
Event Description
It was reported by a nurse practitioner that the patient experienced more seizures with the vns settings adjustments that were made at the patient's previous visit. The nurse practitioner attempted a separate day-night based dosing for the patient and that the patient's generator was not yet at therapeutic levels to date. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8824651

 28 
 on: August 10, 2019, 03:07:30 AM 
Started by dennis100 - Last post by dennis100
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Injury   
Event Description
It was reported by patient during request for information on how vns works and the different options for settings that they were recently hospitalized due to increase in seizures. The patient wanted to have settings increased. The patient stated they are still having seizures despite meds and vns. The manufacturer¿s battery life calculator estimated that the patient¿s generator was not expected to be at near end of service at the time of the report based on the patient¿s available programming history. No relevant 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=8768632

 29 
 on: August 10, 2019, 03:06:46 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/08/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was in a car accident in (b)(6) 2019. Since then the patient has been titrated up twice and was having an increase in seizures. The patient was also reportedly feeling vibration in their chest. X-rays were reportedly "okay" no further relevant infomraiton has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8761383

 30 
 on: August 10, 2019, 03:06:05 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/17/2019
Event Type  Malfunction   
Event Description
It was reported the patient was being referred for prophylactic replacement. It was later stated that per the patient's mother, the patient has recently had an increase in seizures. At this time, it is not clear if the patient's increase in seizures is a contributing reason for the patient's replacement. 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=8784974

Pages: 1 2 [3] 4 5 ... 10