Pages: [1] 2 3 ... 10
 1 
 on: July 17, 2019, 12:01:03 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the physician that the patient was seen with daily increased events. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7876471

 2 
 on: July 16, 2019, 11:59:35 PM 
Started by dennis100 - Last post by dennis100
Model Number 103
Event Date 02/11/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a physician that a vns patient experienced bradycardia/ av block and was sent to the hospital. The patient did not experience pain and reacted abnormally along with having low blood pressure. The patient was later dismissed with normal vital functions, but severe swallowing problems. Treating physician does not believe the event is related to vns. An increase in seizures was also reported, but this was below pre-vns levels. At the moment, good faith attempts to obtain further information have been unsuccessful to date.
 
Event Description
Reporter indicated the patient had no history of cardiac events. The patient's father did have a myocardial infarction at age (b)(6). The patient does have pre-existing hypertension. The patient experienced bradycardia during the event. The heart rate prior to the bradycardia was regular, and during the event was irregular. The blood pressure prior to the event was 133/110; during the event it was 90/40. The date of the bradycardia event was (b)(6) 2012. The patient did not have any symptoms, but "did not feel well in general". The patient did not experience any traumatic events prior to the bradycardia, and had no trigger events. The bradycardia did not occur after a medication change. The bradycardia did not correspond with the vns stimulation on time, did not occur during vns diagnostics testing, and did not occur following a setting change. Electrocardiography information was not provided as it was not available. The bradycardia event is not felt to be related to the vns, and it is not felt to have exacerbated or co-currently contributed to the bradycardia. The patient was hospitalized as an intervention, and experienced a myocardial infarction which required the placement of two cardiac stents. The vns generator is currently programmed on, with settings of 2ma output current, 30hz, 250 pulsewidth, 30 sec on, 5 min off. The arrhythmia event has not recurred.
 
Manufacturer Narrative
Type of report, corrected data: the initial mdr report inadvertently omitted the 30-day report designation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2603911

 3 
 on: July 16, 2019, 11:54:36 PM 
Started by dennis100 - Last post by dennis100
Model Number 101
Event Date 09/04/2009
Event Type  Injury   
Event Description
Reports indicated a vns therapy patient was admitted to the hospital for bradycardia and was in the ccu. The cardiologist feels that the patient's bradycardia may be related to his vns. Additional information received indicated the physician originally believed the vns may have had something to do with the bradycardia and wanted to turn it off but later decided the patient still needs a pacemaker. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1491034

 4 
 on: July 16, 2019, 11:37:15 PM 
Started by dennis100 - Last post by dennis100
Model Number 10X
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/20/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient went had bradycardia as well as a dip in blood pressure prior to implantation. The surgery was aborted. The surgeon did not attribute any of the issues to vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7876347

 5 
 on: July 16, 2019, 11:35:32 PM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/31/2018
Event Type  Malfunction   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient's experienced an increase in seizures hours after surgery. The vns was not programmed on at the time as it was a new implant. Follow up with the surgeon revealed that he was unsure as to the cause of the increase in seizures, but it may have been the result of an infection experienced by the patient following surgery. It was stated that the patient developed a colon infection (clostridium difficile colitis). The surgeon stated that it was unrelated to vns, but that it did occur right after the surgery. It was stated that the patient had a fever and diarrhea the night after surgery. It was reported that antibiotics can cause the infection, but it was strange for it to happen immediately. The surgery was reported as routine with no excessive manipulation of the vagus nerve. The patient was fine post-op and went home. The patient later experienced the symptoms. The increase in seizures was above the pre-vns baseline. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7907010

 6 
 on: July 16, 2019, 11:34:48 PM 
Started by dennis100 - Last post by dennis100
Model Number 303-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 05/01/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported that this patient had high impedance which the doctor believed the high impedance suggested a break in the wiring. Additional information was received from the patient¿s mother who stated that the patient is having uncomfortable stimulation and the device is pulsating in the patient¿s neck. The patient¿s device was turned down to 0. 75ma. The patient¿s mother also stated that the patient has migraines, nausea, and vomiting, and feels that his heart speeds up since receiving the m106. Clinic notes were received which stated that the patient feels that his vns is not working and he is still having seizures, mostly under stress due to living conditions. The neighborhood they live in is quite violent. It was stated the patient¿s spells began 3 months ago, and the patient feels they are worsening. The doctor stated that the patient had an increase in seizures, although this was felt to be due to vns malfunctioning. Additional information was received from the patient¿s mother stating that the patient's left neck began to swell and the patient went to the er. They had no way to program the device off. Steroids were administered and the swelling as since subsided. The patient's device was disabled shortly after this and the patient is doing slightly better. This patient received a lead and generator replacement. The explanted products have not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842002

 7 
 on: July 16, 2019, 11:33:08 PM 
Started by dennis100 - Last post by dennis100
Model Number 303-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 05/01/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported that this patient had high impedance which the doctor believed the high impedance suggested a break in the wiring. Additional information was received from the patient¿s mother who stated that the patient is having uncomfortable stimulation and the device is pulsating in the patient¿s neck. The patient¿s device was turned down to 0. 75ma. The patient¿s mother also stated that the patient has migraines, nausea, and vomiting, and feels that his heart speeds up since receiving the m106. Clinic notes were received which stated that the patient feels that his vns is not working and he is still having seizures, mostly under stress due to living conditions. The neighborhood they live in is quite violent. It was stated the patient¿s spells began 3 months ago, and the patient feels they are worsening. The doctor stated that the patient had an increase in seizures, although this was felt to be due to vns malfunctioning. Additional information was received from the patient¿s mother stating that the patient's left neck began to swell and the patient went to the er. They had no way to program the device off. Steroids were administered and the swelling as since subsided. The patient's device was disabled shortly after this and the patient is doing slightly better. This patient received a lead and generator replacement. The explanted products have not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842002

 8 
 on: July 16, 2019, 11:31:38 PM 
Started by dennis100 - Last post by dennis100
Model Number 304-30
Device Problem Fracture
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient had an emergency surgery to explant a lead that was stated per the stepdad to be internally burning him. It was unknown if there was trauma to the site, if devices were explanted, diagnostics, or who the surgeon was. A call was received confirming that both the generator and lead were explanted due to painful stimulation, exposed lead wires and "drainage" from the exposed wires. The devices were to be shipped back for analysis. Surgical operation notes were received indicating pus, an infection at the electrode site and "exposed, infected" devices, however it was stated per the patient's physician that nothing had happened to the lead or generator and that the patient had also been sent to "infectious disease" who had clarified that there was no infection seen. Impedance measurements from march 2018 showed ok impedance, within normal limits. The physician stated the patient had been doing well with vns and was looking to have the patient re-implanted with vns. The devices were returned for analysis, however analysis has not been completed to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7883963

 9 
 on: July 16, 2019, 11:30:05 PM 
Started by dennis100 - Last post by dennis100
Model Number 303-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 05/01/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported that this patient had high impedance which the doctor believed the high impedance suggested a break in the wiring. Additional information was received from the patient¿s mother who stated that the patient is having uncomfortable stimulation and the device is pulsating in the patient¿s neck. The patient¿s device was turned down to 0. 75ma. The patient¿s mother also stated that the patient has migraines, nausea, and vomiting, and feels that his heart speeds up since receiving the m106. Clinic notes were received which stated that the patient feels that his vns is not working and he is still having seizures, mostly under stress due to living conditions. The neighborhood they live in is quite violent. It was stated the patient¿s spells began 3 months ago, and the patient feels they are worsening. The doctor stated that the patient had an increase in seizures, although this was felt to be due to vns malfunctioning. Additional information was received from the patient¿s mother stating that the patient's left neck began to swell and the patient went to the er. They had no way to program the device off. Steroids were administered and the swelling as since subsided. The patient's device was disabled shortly after this and the patient is doing slightly better. This patient received a lead and generator replacement. The explanted products have not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842002

 10 
 on: July 16, 2019, 11:28:23 PM 
Started by dennis100 - Last post by dennis100
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a large dog had jumped on the patient and the patient believed the vns had migrated. It was reported that the vns started firing and not stopping, which made the patient's throat feel tight. It was stated that the patient's o2 stats were ok. The patient's grandmother taped the magnet over the vns to magnet disable the device. The patient was admitted to the hospital and seen by neurology. The vns was disabled and the patient was sent home. It was stated that the patient was scheduled for surgery to fix or replace the vns. It was later reported that the patient also felt vibration and experienced hoarseness. Diagnostics were within normal limits. It was stated that the vns was disabled as the patient felt better when the vns was off. 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=7911408

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