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dennis100
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« Reply #360 on: January 20, 2019, 03:36:10 AM »

misc pain
Model Number 102
Event Date 02/23/2012
Event Type  Injury   
Event Description
Product analysis was completed on the returned vns generator. No anomalies were noted, and the generator performed per specifications.
 
Event Description
Reporter indicated a patient was to have the vns generator and possibly the lead explanted and not replaced due to patient reports of constant pain in the left upper chest and neck. The surgery was to have taken place on (b)(6) 2012, but this has not been confirmed. Attempts for further information are in progress.
 
Manufacturer Narrative
Operator of device, corrected data: the incorrect operator of the device was inadvertently reported as the health professional on the initial mdr report. The correct operator of the device is the patient.
 
Event Description
All attempts to the reporter for additional information and if explant of the vns occurred have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Reporter indicated the patient had the vns generator explanted on (b)(6) 2012, but the vns lead was left in the patient. The vns generator was explanted at the request of the patient. The generator has been returned and is pending product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2498646
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dennis100
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« Reply #361 on: January 20, 2019, 03:36:51 AM »

Model Number 103
Event Date 02/18/2013
Event Type  Injury   
Event Description
It was reported that following generator and lead replacement surgery on (b)(6) 2013 due to high impedance, the vns patient experienced throat tightness and pain that did not occur with stimulation on-times. The patient was unable to tolerate the device settings that were programmed on the previous device. The patient reported that, since replacement, his face would sometimes swell. Diagnostic results showed normal device function. Follow-up revealed that physician attributed these issues to vns. The patient was given anti-inflammatory medications and his device settings were decreased. The physician also indicated that stress may have contributed to the events and that no medication changes preceded the onset of the events additional information was received stating that the patient also began experiencing numbness in the jaw and neck. The patient¿s seizures were noted to be more frequent and longer in duration. The physician attempted to increase the device settings but was unable to due to the patient¿s pain. The physician attributed the increase in seizure frequency and duration to the inability to increase device settings to therapeutic levels. Attempts for additional relevant information have been unsuccessful to date. The high impedance event was reported in manufacturer report #1644487-2013-00524.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4789910
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dennis100
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« Reply #362 on: January 21, 2019, 12:17:50 PM »

Model Number 302-20
Event Date 06/02/2014
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative

Event Description
During review of the available programming and diagnostic history, it was observed that the vns patient¿s device was disabled on (b)(6) 2004. Follow-up revealed that the patient underwent surgery on (b)(6) 2004 to explant her generator due to neck pain and lack of efficacy. The relationship between the neck pain and vns is unknown. The patient¿s neck pain was not related to stimulation and continued despite generator explant. The patient¿s lack of efficacy was attributed to the time needed to ramp up the patient¿s device settings to therapeutic levels. No patient manipulation or trauma was reported that may have caused or contributed to the patient¿s neck pain. The explanted generator has not been returned to date.
 
Event Description
On august 21, 2014 product analysis was completed on an explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator铠output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications; there were no anomalies found with the pulse generator. Product analysis on the lead was completed on august 26, 2014. Scanning electron microscopy image of the connector pin surface with opaque appearance shows that pitting or electro-etching conditions have occurred on the pin. Since portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3946880
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dennis100
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« Reply #363 on: January 24, 2019, 05:07:46 AM »

Model Number 103
Event Date 06/05/2014
Event Type  Injury   
Event Description
On (b)(6) 2014 it was reported that the patient had pocket revision surgery to correct the pain in july 2014 but that the pain started again recently. Now the patient is experiencing a headache, chest pain, and pain on the left side of the neck. The patient was referred for x-rays. The patient saw the neurologist on (b)(6) 2014 complaining of pain and per the neurologist, the lead is protruding in the armpit area. The neurologist did not have a programmer to turn off the vns. The neurologist referred the patient for surgery as the patient wants the vns removed. Although surgery is likely, it has not occurred to date. On (b)(6) 2014 it was reported that the physician had the vns turned off due to the patient¿s complaints of pain radiating up her neck, migraines, and pain at the generator site. The settings prior to being disabled were noted to be current output: 0. 25ma/frequency: 15hz/pulse width: 250usec/time on: 30 sec/time off: 1. 1 min/magnet output: 0. 50ma/mag time on: 60 sec/mag pw: 500usec. System diagnostics test was performed which showed lead impedance: ok/impedance value: 3647ohms/ifi: no. Attempts were made for further information but were unsuccessful.
 
Event Description
It was reported that the vns patient¿s generator had migrated toward the anterior axillary line. The patient had been experiencing some pain at her generator site. The patient did not have any fever, abrasions, or discoloration; however, the patient felt her generator was protruding into her armpit. The generator incision had healed well and the device was still functioning as expected. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3906342
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dennis100
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« Reply #364 on: January 24, 2019, 05:08:37 AM »

Model Number 102
Event Date 07/17/2014
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient decided to not explant his device.
 
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for vns explant due to intolerance of the implant with swelling and pain. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4038429
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dennis100
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« Reply #365 on: January 25, 2019, 09:35:01 AM »

Model Number 300-20
Event Date 07/24/2014
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Corrected data: the initial mfr. Report inadvertently reported the event as both serious injury and malfunction; however, this should only have been reported as a serious injury.
 
Event Description
Additional information was received which stated the patient experienced neck pain prior to the revision surgery, even though the diagnostics were within limits. It was noted that when the lead was explanted fluid was found inside. After the revision surgery, the patient's neck pain didn't go away for the first few days after the surgery, but then it did resolve.
 
Event Description
It was reported that the vns patient was experiencing intense pain in her neck. The patient¿s device was subsequently disabled; however, the patient continued to experience stabbing pains but less frequently than before disablement. X-rays were taken and the lead reportedly appeared to be ¿unwrapped from the nerve. ¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted lead; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027949&pc=LYJ
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dennis100
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« Reply #366 on: January 28, 2019, 06:06:30 AM »

Model Number 303-20
Event Date 08/13/2014
Event Type  Injury   
Event Description
It was identified that a duplicate report of this patient's infection was submitted in mfg report #: 1644487-2014-02448. This report will house any future information related to the infection. It was reported that the infection may have been related to the sutures from surgery, although surgery was over a year prior.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing pain and possibly developed an infection at lead incision site. No further information has been received to date.
 
Manufacturer Narrative
Suspect medical device, corrected data: the initial report inadvertently reported the incorrect suspect device. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect suspect device. Evaluation codes, corrected data: the initial report inadvertently did not report the device history records being reviewed and report the results and conclusion codes incorrectly. Manufacturer device history records were reviewed. A review of device history records showed that the lead met specifications for sterilization testing prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4113036
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dennis100
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« Reply #367 on: January 28, 2019, 06:07:18 AM »

Model Number 304-20
Event Date 08/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the lead being placed on the nerve upside down was confirmed during lead replacement surgery. Further follow-up revealed that the patient requested that the vns be explanted due to ear pain. The patient's device was programmed off, but the patient requested explant. It was reported that despite the lead replacement. The patient claims to still have a buzzing noise along with severe constant ear pain. It was reported that device diagnostics have been within normal limits and there is no belief of device malfunction. There is no relationship of the vns to the patient't buzzing noise and ear pain. The patient underwent vns explant on 12/12/2014.
 
Event Description
Additional information was received stating that the vns patient was referred for surgery to explant her generator. The patient reportedly was hearing a buzzing noise from her device. The patient¿s generator has not been explanted to date.
 
Event Description
It was reported that the vns patient¿s lead was implanted upside-down on the patient¿s nerve. It is unclear how the physician made this determination. An implant card was received stating that patient underwent lead replacement surgery on (b)(6) 2014 due to lead failure. The explanted lead has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4110421
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dennis100
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« Reply #368 on: January 29, 2019, 08:09:40 AM »

Model Number 102
Event Date 11/23/2009
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was experiencing pain at his electrode site. The patient¿s device was disabled and the patient was admitted to the hospital for x-rays and further evaluation. The patient¿s physician stated that the patient¿s pain was related to vns. Follow-up revealed that the patient¿s device was disabled because it showed high impedance (dc dc ¿ 7). The patient reported that his pain had improved and was intermittent. The patient was referred for surgery but no known surgical interventions have occurred to date. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin does not appear to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, high lead impedance may be due to incomplete lead pin insertion. Review of the available programming and diagnostic history showed normal diagnostic results on the date of implant.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The replacement generator was tested with the existing lead and diagnostics showed lead impedance within normal limits (impedance value ¿ 3784 ohms). As result, no lead issue was suspected and the reported high impedance was believed to be due to incomplete lead pin insertion. The explanted generator has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4095469
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dennis100
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« Reply #369 on: January 30, 2019, 09:14:23 AM »

Model Number 105
Event Date 05/01/2014
Event Type  Injury   
Event Description
It was reported that the patient started having shoulder pain 1 year after surgery. She saw a physician who turned her device off but this has not subsided the pain. It was later reported that the patient saw the physician again and he turned the device back on and everything is now fine.
 
Event Description
It was reported that the physician was unsure if the pain and migration at the chest were attributed to the patient's fall in (b)(6) 2014. It was reported that the pain is constant and does not occur only with device stimulation. No system diagnostics have been run. The patient has moved to another state and is trying to establish care with a new physician. It is unknown if a non-absorbable suture was used to secure the generator to the facia during implant of the device. No additional relevant information has been received to date.
 
Event Description
It was reported that the vns patient was experiencing intolerable painful stimulation when a diagnostic test was performed during an office visit on (b)(6) 2014. The patient was having sharp pain in the auxiliary region. The patient¿s magnet mode output current was increased, but the patient refused any other changes in device settings. The neurologist stated that the pain was due to the positioning of the device and felt the patient¿s device should be repositioned. It was noted that the patient fell off her bicycle in (b)(6) 2014. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the patient's generator is turned off and she is doing alright. The patient is still searching for a new physician. She does not have a consistent following neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4063923
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dennis100
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« Reply #370 on: February 02, 2019, 08:47:06 AM »

Model Number 302-20
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was complaining of a constant ear ache and feels that the lead wire is sticking out at the generator site. The patient was referred to the surgeon. It was reported that the ear pain started with device stimulation and is now constant. Device diagnostics were reported to be within normal limits. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166466
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dennis100
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« Reply #371 on: February 02, 2019, 08:47:52 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. There were no observed product-related anomalies with the single returned lead portion. Radiographic examination of the connector pin (negative coil) and ring (positive coil) shows the ends of the coils at the crimp locations. Although not conclusive, it is believed that the coils were torn at crimp locations most likely at explant.
 
Event Description
It was reported that the vns patient was referred for surgery due to a depleted battery and lead break. It is unclear how the lead break was determined, but it was attributed to the patient¿s recent mammogram that damaged her device. The date of the mammogram is unknown. The patient presented with pain in her left chest and neck on (b)(6) 2014 following the issue with the mammogram. The patient did not experience any pain related to vns prior to the mammogram. The patient¿s device was disabled and the patient did not have symptoms since the device disablement. The patient stated that the generator had migrated further down towards the axilla aggravating the incision scars. The physician noted that the incision sites appeared normal. The patient¿s device did not show any issues with the device. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due damage from the mammogram. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative

Event Description
Information received on 05/17/2016 for file (b)(4) regarding the patient's post-op nerve damage, states that the patient did have a broken lead after mammogram and underwent a full replacement because of it which was previously reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4168428
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dennis100
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« Reply #372 on: February 02, 2019, 08:48:56 AM »

Model Number 101
Event Date 09/22/2014
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient had severe psychological issues.
 
Manufacturer Narrative

Event Description
Initially, it was reported that the patient complained of pain at the neck area. It was later reported that the patient was at the hospital. It was reported that the patient had gone to the hospital for complaints of chest pain at the generator site. The device was programmed off. It was reported that the generator was at end of service. The patient is currently in the psychiatric hospital and no further action is being taken at this time. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4175290
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dennis100
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« Reply #373 on: February 03, 2019, 04:09:39 PM »

Model Number 103
Event Date 09/04/2014
Event Type  Injury   
Event Description
It was reported that during sinus surgery on (b)(6) 2014 unrelated to vns, the patient had atrial fibrillation. The patient received a cardiogram at that time and was stabilized. Follow-up revealed that no issues were seen with the patient¿s device and normal mode device settings. It is unknown if the patient¿s device was disabled for the procedure. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes were received indicating that the vns patient underwent gallbladder removal surgery and not sinus surgery as initially reported. Three hours following surgery, the patient reported experiencing shooting pain up on the left side of her neck and coughing. Additionally, a lump was located in her left breast below the generator.
 
Event Description
Clinic notes were received stating that the vns patient had been hospitalized the week prior to her office visit on (b)(6) 2014 due to atrial fibrillation and underwent cardioversion in the or. Three hours following surgery, the patient experienced coughing due to shooting pain up the left side of her neck. The magnet was used to temporarily disable the device. The patient¿s device settings were increased following the cardiac events. There was concern that the cardioversion may have somehow altered the patient¿s device settings. The patient subsequently experienced throat irritation at the higher device settings which resolved when the settings were reduced.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4156771
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dennis100
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« Reply #374 on: February 04, 2019, 03:14:25 AM »

Event Date 10/13/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the patient underwent lead replacement surgery due to lead discontinuity. The new lead was placed on the patient's right vagus nerve. An implant card was received indicating that both the generator and lead were replaced. The explanted devices have not been received for analysis to date.
 
Event Description
It was reported that the vns patient responded well to vns which reduced her seizure frequency to one per month. The patient recently began experiencing an increase in seizures and pain in her neck. During an office visit on (b)(6) 2014, the patient¿s device showed high impedance. The patient¿s medications were subsequently increased. X-rays were taken and reported by the radiologist to show lead discontinuity. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245782
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dennis100
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« Reply #375 on: February 04, 2019, 03:15:05 AM »

Model Number 302-20
Event Date 10/16/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient¿s pain was not related to vns and not occurring with stimulation.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance. The patient¿s device was subsequently disabled. It was noted that the patient has had pain at her left-sided underarm for approximately two years. It is unknown if the pain was related to vns as the patient had several surgeries for other medical conditions. An implant card was received indicating that the patient underwent generator and lead replacement surgery (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Attempts for additional relevant information will be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4251812
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dennis100
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« Reply #376 on: February 04, 2019, 03:15:54 AM »

Model Number 104
Event Date 10/20/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the patient¿s vns is protruding out of her skin and about 40% of it is exposed. There were clear signs of infection; swelling with yellow pus and is sensitive at the incision line but not surrounding areas. The patient¿s mother reported that it has been like this for 2-3 weeks and initially they covered it with a band-aid but it is now too painful to cover. The patient was referred to the surgeon. The surgeon stated that the patient scratched out her vns, which is why it is coming out through the chest and not at the original incision site. He admitted her to remove the unit and the lead wires due to infection. The surgeon removed the device on (b)(6) 2014 and noted there were no plans to re-implant as the patient had scratched the device out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4285570
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« Reply #377 on: February 04, 2019, 03:16:36 AM »

Model Number 302-20
Event Date 10/02/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received on (b)(6) 2014. Clinic notes dated (b)(6) 2014 indicate that the patient was having starring spell seizures almost daily and that swiping the magnet stopped his seizures. The patient¿s vns showed high impedance. It was noted that the patient would be referred for x-rays and surgery. Clinic notes dated (b)(6) 2014 indicate that the patient had several small seizures and that he was doing well with seizure control until his trigeminal neuralgia started. The neurologist stated that once his trigeminal neuralgia pain is resolved he thinks his seizure frequency will return to baseline levels.
 
Event Description
On (b)(6) 2014, it was reported that high impedance was observed that day for the patient during a system diagnostics test. The patient was sent for a chest and neck x-ray and the device was disabled. The patient was referred for a full revision. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(4) 2014 it was reported that the patient was scheduled for a full revision surgery. Surgery took place on (b)(6) 2014. The explanted generator and lead were returned for product analysis on (b)(4) 2014. Product analysis is still underway and has not yet been completed.
 
Event Description
On 12/08/2014 product analysis was completed on the lead. A portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the generator on 12/11/2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4154445
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« Reply #378 on: February 05, 2019, 03:26:07 AM »

Model Number 102
Event Date 11/13/2014
Event Type  Malfunction   
Event Description
The patient is a (b6) male with intractable epilepsy. One month ago the patient underwent removal of his vagal nerve simulator due to "pain," "burning," and discomfort. The device did not prevent/reduce seizure activity as intended. This particular generator and lead were implanted approximately three and a half years ago. Of note, the patient underwent vagal nerve stimulator implantation originally eight years ago. Of note, the patient initially underwent implantation of vagal nerve simulator which was removed and replaced three times due over the course of five years due to various reasons including pain, discomfort, infection and migration of device due to weight loss.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4371813
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« Reply #379 on: February 05, 2019, 03:27:15 AM »

Model Number 102
Event Date 01/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient had their generator and lead explanted due to neck pain. The explanted generator and lead were returned to the manufacturer for evaluation. Product analysis is planed but has not been completed. There was no replacement of the explanted products on the date of explant.
 
Event Description
It was clarified that the surgeon explanted the patient because the patient wanted to have a mri performed. The surgeon explained to the patient about having the vns removed, but the patient insisted on having the vns explanted. The patient was being treated for back and neck pain, and another physician told the patient that she needed a mri. The explant was done for the mri and not due to the pain. Analysis of the explanted devices was completed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4220713
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« Reply #380 on: February 06, 2019, 03:05:04 AM »

Model Number 302-30
Event Date 11/19/2014
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include that the explanted devices were discarded. Evaluation codes, conclusions; corrected data: the previously submitted mdr inadvertently did not include that the explanted devices were discarded.
 
Event Description
It was reported that the vns patient underwent surgery to reposition the device due to infection, pain, and migration. When the patient was opened, a lead fracture was observed. The patient¿s generator and lead were replaced during the procedure. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received stating that the vns patient did not develop an infection but presented with infection-like symptoms (redness and pain). The patient was referred for surgical consult due to migration. It is unknown what may have caused or contributed to the device migration. The patient was reported to be doing well following replacement surgery.
 
Event Description
The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4348044
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dennis100
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« Reply #381 on: February 07, 2019, 09:17:25 PM »

Model Number 103
Event Date 12/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a repositioning surgery due to migration of the generator. The generator had moved to the shoulder and clavicle and was causing pain. Over the past several weeks the patient has complained of left shoulder and clavicle pain. It is almost constant and is particularly brought on by weight lifting and other movements. The patient participates in very strenuous activities and the surgeon believes that these activities caused the generator to break through the encapsulation and migrate upward. System diagnostics were performed which showed the device to be functioning properly, with an impedance value of 2339ohms. The surgeon brought the patient in on (b)(6) 2014 to reposition it lower to help with discomfort.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4401903
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dennis100
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« Reply #382 on: February 09, 2019, 03:15:01 AM »

Model Number 302-20
Device Problem Fracture
Event Date 10/14/2013
Event Type  Malfunction   
Event Description
It was reported that a patient had been experiencing pain around her generator site since her last generator replacement. The pain was noted to have increased in frequency and severity over the course of the 5 years, and it was stated that she recently began having severe sharp pain at the site that worsens when trying to lift heavier items. The physician had instructed her to not pick things up. The patient now feels pain all the time and also experiences tingling in her hands and feet and pain in her ears. She was unsure if the newer events are related to vns. The patient stated not having any sort of trauma to the site. The pain is constant and seemed to be related to the placement of the device. The physician was recommending the newer device with the tachycardia detection as he believed it would benefit her seizure control. The patient further reported that she was experiencing sharp pains with vns stimulation. It was stated that she had issues with pain in the past and had settings adjusted at her last appointment, however the pain had now returned. At the patient's follow up appointment, it was noted that the patient's device was showing high impedance as observed from two different programming systems. The patient did not report any trauma that may have led to damage of the lead. It was further stated that after the device was disabled for the high impedance, the patient's painful stimulation resolved. Clinic notes were received also indicating that the patient was having more seizures with vns. Battery status was noted to be ok. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8223185
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dennis100
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« Reply #383 on: February 09, 2019, 03:15:41 AM »

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

Event Description
It was reported that the patient had been hospitalized for psychosis and had throat pain. It was stated that the patient¿s pain was caused by an increase in settings. Programming history was reviewed for the patient. No programming anomalies were seen. Further attempts for information were made but have been unsuccessful to date. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8235506
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dennis100
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« Reply #384 on: February 09, 2019, 03:16:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient believed she experienced issues with her vagus nerve that caused stomach pain, pain in her neck that radiates down to the chest, migraines, and black out spells. The company representative indicated that the patient's generator system diagnostics were within normal limits. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8224067
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dennis100
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« Reply #385 on: February 09, 2019, 03:16:42 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/09/2019
Event Type  Injury   
Event Description
It was reported that the patient was being referred for pocket revision surgery due to migration. Information was then received that the patient wanted the device to be explanted and did not want a replacement. The patient wanted the generator removed as he works for (b)(6) and the device caused pain when lifting boxes. The patient¿s generator and lead were explanted. The devices have not been returned to livanova as the devices are discarded after surgery. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8288427
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dennis100
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« Reply #386 on: February 09, 2019, 03:17:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2018
Event Type  Injury   
Event Description
It was reported that a patient was referred for generator replacement due to the patient experiencing pain, migraines, and memory loss. It was further noted that the device was "bothering" the patient. The patient was doing well with her medication and felt she did not need vns anymore. It was mentioned that the device was on "low dosing". The generator was explanted with no replacement. The device was not expected to be returned for analysis as the facility was a "no return" facility. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8241560
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dennis100
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« Reply #387 on: February 09, 2019, 03:18:09 AM »

Model Number 302-20
Device Problem Fracture
Event Date 09/01/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported via clinic notes received by the manufacturer that following the generator replacement several years prior, the patient experienced significant side effects and significant pain in his neck. A fractured wire was found and ¿after repair,¿ the patient had experienced improvement in his discomfort. The implant card from the surgery indicated that the impedance at the time of the surgery completion was "ok. " no impedance value was provided. The reason for the vns generator replacement was battery depletion. It was unclear if the lead was repaired using non-manufacturer products or if the lead was replaced. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8245610
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dennis100
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« Reply #388 on: February 09, 2019, 03:18:43 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/31/2018
Event Type  Injury   
Event Description
The patient reported that they are having inflammation and are unable to turn their neck. The patient¿s neurologist was looking for a surgeon in order to have their device explanted. Clinic notes were received for the patient¿s explant surgery. Per the clinic notes, the patient has neck pain that she believes is due to the lead pulling on their nerve. The pain occurs intermittently and mild head turns can set off severe pain in her neck and in the muscles, and she limits her neck motion and arm motion to avoid pain. The patient¿s device was disabled for about two years. Programming history was reviewed for the generator. The generator normal mode was disabled on (b)(6) 2013, however magnet mode was left on. The patient¿s generator was completely disabled on (b)(6) 2015. No programming anomalies were seen. Information was received from the physician's assistant. It was unknown when the patient¿s pain began, and the patient had x-rays taken that appeared normal. The physician¿s assessment on the pain was unknown. The patient¿s device was disabled prior to her coming to their clinic, and the reason for disablement was unknown. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8272345
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dennis100
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« Reply #389 on: February 09, 2019, 03:19:27 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 12/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the patient that she had severe pain on the right side of her brain that radiated down through her body into her legs. The patient reported everything twitched and that it was not a seizure. The patient continuously felt like her head was pounding and pain would not go away. The patient did not take medication and saw physician later in the day who stated battery had dropped. The patient stated her and the physician could not understand why her battery had dropped drastically and caused that pain. The patient stated that she stays away from any electronics that may cause accidental magnet stimulation and did not believe this to be the cause of the pain. The tablet data for the generator was received and reviewed by the manufacturer. No battery status indicator was flagged in the data available, which was from approximately half a year prior to the allegation. As no recent data is available, it was unable to be assessed whether the alleged premature depletion was present. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The device was found to have been manufactured using the laser routing process. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8268943
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