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dennis100
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« on: April 30, 2017, 01:54:58 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
« Last Edit: July 08, 2017, 11:10:30 PM by dennis100 » Logged
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« Reply #1 on: April 30, 2017, 01:55:31 AM »

Model Number 102
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient's vns device slips under the patient's left underarm/ breast area and can be painful. The patient's mother requested surgery to reposition the device. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3404966
« Last Edit: July 08, 2017, 11:10:51 PM by dennis100 » Logged
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« Reply #2 on: April 30, 2017, 01:56:10 AM »

Model Number 102
Event Date 01/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient needed assistance finding out how to get a new generator because her generator had "migrated" to "the edge of her left underarm". Per the patient, she had been seen by a surgeon and he recommended a new generator. Follow up with the physician found that the generator migration was first observed two years ago. The physician believes the generator has migrated and states that it is in axilla eight inches from where implanted. No patient manipulation or trauma occurred which is believed to have caused or contributed to the migration. Surgical intervention has been planned, but not taken due to insurance issues. The physician states that it would be optimal to replace or remove the vns device. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3443526
« Last Edit: July 08, 2017, 11:11:16 PM by dennis100 » Logged
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« Reply #3 on: April 30, 2017, 01:57:00 AM »

Model Number 105
Event Date 05/01/2014
Event Type Injury
Manufacturer Narrative

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
« Last Edit: July 08, 2017, 11:11:35 PM by dennis100 » Logged
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« Reply #4 on: April 30, 2017, 01:58:15 AM »

Model Number 103
Event Date 02/01/2012
Event Type Injury
Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient had been scheduled for prophylactic battery replacement surgery that day. The patient was complaining of lead poking the skin by the generator. System diagnostics were performed prior to surgery and the impedance was within normal limit of 3757 ohms. Upon re-positioning of the generator, the surgeon touched the generator with the electrocautery in error. When system diagnostics were then performed after, the device alerted to eos when it had previously not been at eos. The generator was then replaced. A system diagnostics test after replacement showed the device to be functioning properly at 2471 ohms. The explanted generator could not be returned to the manufacturer for product analysis as the hospital does not return devices.

Event Description
On (b)(6) 2012 the patient reported that she has a "knot" in her neck. The patient also indicated that the lead is still protruding from her neck.

Event Description
Additional information was received on (b)(6) 2012, when the operative report was received from the patient's surgery on (b)(6) 2012. Preoperative diagnostics showed that device to be working well with appropriate impedance and a battery swipe appeared to be functioning according to the notes. The notes further state that once they got the patient's chest open, they removed the generator and reattached it and cleaned out the generator pocket to have a better position for it. When they re-tested the generator after this, diagnostics showed the generator was at end of life. The surgeon stated that this may have been exposed to electrocautery. They tested the device several times and it would not function. The generator was therefore replaced and diagnostics showed results within normal levels of 2500 ohms. The patient's settings were reset to the previous settings without difficulty and the device was rechecked with good results. The notes also indicate that prior to surgery the patient was having good benefit from vns but this was starting to be less functional as the generator itself appeared to may have rotated and was causing her some discomfort at the incision site. The patient was also reported to have not believed the battery was working well. The patient later indicated that sometime around (b)(6) 2012, she contacted her neurologist because she was having pain around her generator; under her arm and in her neck. The patient also indicated that her magnet was not working and her lead was protruding from the neck and catching on clothing which caused pain. She was also short of breath. The physician then ordered x-rays to rule out bronchitis or pneumonia since she was short of breath. The x-rays showed nothing so the physician assumed it was a problem with her vns device and referred her to the surgeon.

Event Description
On (b)(6) 2012, a vns implanting surgeon the vns patient's generator had migrated and the lead was pulling. On (b)(6) 2012, the neurologist reported that the vns patient was complaining of pain around the generator site close to her underarm and neck for a couple of months. The patient stated that the areas are tender and painful but is not particular to stimulation. She also says that the lead is protruding at the neck site. The physician referred the patient to a surgeon regarding the protrusion. The patient also reported that she doesn't feel stimulation when she swipes her magnet. The patient's seizures however were actually doing better. The neurologist later reported that the patient's generator has actually flipped on its side in the patient's chest so instead of lying flat and flush it is sticking out which is causing the pulling the patient feels on the lead. The patient has been referred to a surgeon for prophylactic replacement due to the migration and to alleviate the potential for infection. The patient denied any manipulation or trauma that could have caused the device to have moved to its side. The patient stated that the generator is able to be interrogated but she still does not feel any magnet stimulation when she swipes the magnet. The reason the patient was not feeling magnet stimulation was not due to becoming accustomed to the magnet settings according to the manufacturer's consultant. Attempts for further information were made but no additional information was received from the physician. Although surgery is likely, it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2574353
« Last Edit: July 08, 2017, 11:11:55 PM by dennis100 » Logged
dennis100
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« Reply #5 on: April 30, 2017, 01:59:55 AM »

Model
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« Reply #6 on: April 30, 2017, 02:00:51 AM »

Model Number 102
Event Date 07/06/2009
Event Type Injury
Event Description
It was initially reported that a vns patient experienced electrical shocking sensations in the chest area. The treating neurologist evaluated the patient's generator and found it to be working within normal limits. Further interventions were to program the patient's generator off. After the generator was programmed off, the patient continued to experience pain around the generator area along with a burning sensation that radiated to the underarm with swelling in the chest. Information received from the treating neurologist revealed the patient went to the er for intervention to be taken due to the chest pain. At the moment, it is known that the event is not related to stimulation, however, the root cause of the events is still unknown. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464539
« Last Edit: July 08, 2017, 11:12:35 PM by dennis100 » Logged
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« Reply #7 on: May 03, 2017, 12:43:55 AM »

Device Problem Migration of device or device component
Event Date 11/01/2013
Event Type Injury
Event Description
It was reported that the patient¿s left side of the neck is swollen from behind her left ear to down her neck, and that when she leans on her left side, she feels the battery sliding down underneath her axilla. It was reported that this has been going on for a year on and off and the welling would come and go. The patient reported that it started just prior to her cabg last year, but has worsened since that surgery. She said for the last week, it has remained swollen and she is coughing a bit of blood from her throat. The patient now wants the device removed. The patient saw a cardiologist and she doesn¿t have jvd, but the cardiologist stated that possible the lead was eroding the vocal cord area. The patient stated that she has had an mi and cva this past (b)(6) 2014. Per the patient¿s primary care physician, she does not need to see an ear, nose, and throat physician. However, the patient is still having neck swelling on the left side of her neck. Although surgery is likely, it has not occurred to date.

Event Description
Information was received from two of the patient's physicians. The first physician indicated the last device check was on (b)(6) 2015 showing normal battery status, normal lead impedance and no vns parameters were altered. The physician indicated that the patient has not reported any of the prior symptoms to him. The second physician indicated the last device check was (b)(6) 2015 and the device battery was indicated to be at end of service, lead impedance was ok and no parameters were changed. He indicated that that patient had reported dysphagia and throat pain but none of the other prior symptoms. No specific interventions were undertaken. Clinic notes were subsequently received for the (b)(6) 2015 office visit which indicated that the device would be replaced due to end of service. The notes indicated that the vns give her trouble with breathing but no specific intervention is referenced. The patient subsequently called the manufacturer and reported that her seizures were worse than before vns. The patient underwent pulse generator replacement on (b)(6) 2015 however high lead impedance was detected when the indwelling lead was connected with the new pulse generator despite repeated removals and insertions. The surgeon elected not to replace the lead during the surgery. Post-implant lead impedance also measured high. Lead impedance with the prior pulse generator was normal. Review of prior programming and diagnostic data reveals fluctuating lead impedance suggesting an intermittent short circuit condition. A battery life calculation using the available programming history showed approximately 0. 2 remaining until neos = yes. No known additional surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
It was later reported that the patient has ¿burn marks¿ over her lead. Good faith attempts for further information from the physician have been unsuccessful.

Event Description
The patient indicated that she feels her lead has moved, is wrapped around her esophagus, is choking her and causing throat pain. She stated that she has continuous voice alteration but no longer feels device stimulation since the time of her last interrogation 2 months prior. She stated she has coughs up blood and has a tight feeling in her chest. She stated that her generator is under her armpit. She indicated her neurologist will be speaking with her other providers, including her cardiologist, for clearance to replace her generator and lead. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

Event Description
On (b)(6) 2015 the patient reported that he is having serious problems with the vns. The patient later reported that she is still having neck pain and swelling in the left side of the neck, feeling vibration and pulsing. She also stated that when she places the magnet over the device, she feels that stimulation is stronger. She also coughed up some blood.

Event Description
Operative notes containing a record of the pulse generator replacement on (b)(6) 2015, during which high impedance was observed following connection of the new generator to the indwelling lead, were received. The operative notes state that it was suspected that the high impedance measurement may possibly be due to emi from surrounding medical devices and was therefore left in place for interrogation in the postanesthesia care unit.

Event Description
Information was received indicating that the patient was scheduled for lead revision surgery. The patient subsequently reported that she was hospitalized due to multiple seizures and stated she was experiencing unusual seizures. The patient underwent surgery for the high impedance condition as reported and described in mfr. Report # 1644487-2016-00375.

Event Description
A provider reported that the patient called her to schedule an appointment to check on her vns which since (b)(6) (2015) is causing burn marks. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334258
« Last Edit: July 08, 2017, 11:12:54 PM by dennis100 » Logged
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« Reply #8 on: May 13, 2017, 03:20:32 AM »

Model Number 102
Event Date 08/01/2008
Event Type Injury
Event Description
Initial reporter indicated that the patient's vns generator has moved laterally into the axilla. The generator was repositioned surgically. Good faith attempts are being made for additional details surrounding the cause of the migration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1171349
« Last Edit: July 08, 2017, 11:13:13 PM by dennis100 » Logged
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« Reply #9 on: May 13, 2017, 03:21:21 AM »

Model Number 302-20
Event Date 08/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected.

Event Description
Reporter indicated a vns patient had developed two masses in her left breast that were adjacent to the vns generator. It was later reported that the patient was experiencing increased seizures and that a "lead disconnect" was noted on a ct scan. The reporter also stated the vns had migrated to the left axilla, but it is not known if it is the generator or the lead that has migrated. The patient's medications were changed and the vns settings were adjusted as interventions for the seizure increase. The reporter has referred the patient for revision surgery and a surgery date is planned for 2008. Attempts for additional info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1191486
« Last Edit: July 08, 2017, 11:13:42 PM by dennis100 » Logged
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« Reply #10 on: May 15, 2017, 12:39:44 AM »

Model Number 102
Event Date 07/01/2008
Event Type Injury
Event Description
It was reported that a vns pt's generator had moved medially towards the anterior axila line and was extruding through the skin. The surgeon indicated surgery is likely to reposition the device. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1131043
« Last Edit: July 08, 2017, 11:14:00 PM by dennis100 » Logged
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« Reply #11 on: May 17, 2017, 12:36:58 AM »

Model Number 102
Event Date 03/01/2008
Event Type Injury
Event Description
Reporter indicated that a vns patient's generator had migrated and is now in a position that is painful to the pt,. Because of the pain, the pt presented to the emergency department for eval and further management. Pain medications have not helped. The surgeon indicated that the generator was originally placed submuscularly. Current chest x-rays reviewed by the surgeon showed that the generator is in a submuscular location and has rotated somewhat into the region of the left axilla. Follow-up with the surgeon's office revealed that 3-0 vicryl suture material was used during the initial implant to secure the generator to the fascia. The manufacturer recommends a non-absorbable suture material be used. Generator revision surgery is planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1066657
« Last Edit: July 08, 2017, 11:14:22 PM by dennis100 » Logged
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« Reply #12 on: May 18, 2017, 12:44:34 AM »

Model Number 102
Event Date 10/08/2008
Event Type  Injury    
Event Description  
It was reported that a vns pt experienced a mild infection at the incision site in the left arm pit. The infection was a result of vns implant surgery. Medication (keplex) was added, and the infection resolved.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1243692
« Last Edit: July 08, 2017, 11:14:48 PM by dennis100 » Logged
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« Reply #13 on: May 25, 2017, 12:46:04 AM »

Model Number 102
Event Date 02/20/2009
Event Type  Injury    
Event Description  
Reporter indicated a vns pt's generator had migrated from the chest to the left axilla. The generator was replaced prophylactically. Reporter indicated a silk suture was used to secure the generator in the original surgery and the pt had no trauma and did not manipulate the device. Attempts for return of the explanted generator for analysis have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1362600
« Last Edit: July 08, 2017, 11:15:06 PM by dennis100 » Logged
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« Reply #14 on: June 06, 2017, 06:08:19 AM »

Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported to the mfr that the vns pt has been experiencing discomfort at the device site in the neck. The pt's device has also migrated from the chest to the arm pit area due to recent weight loss. The pt's device has been disabled in 2004 due to an increase in seizure activity (refer to mfr report #1644487-2010-00408). The pt's generator was explanted with no plans for replacement due to the reported irritation and lack of efficacy. The explanted generator has been returned to the mfr for analysis. Product analysis is currently underway. Good faith attempts to obtain add'l info regarding the reported events have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1615471
« Last Edit: July 08, 2017, 11:15:22 PM by dennis100 » Logged
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« Reply #15 on: June 20, 2017, 09:46:50 AM »

Model Number 102
Event Date 04/01/2010
Event Type Injury
Event Description
It was reported that the pt's generator had migrated into her armpit which made wearing a bra painful sometimes. Pt also reported some pain under her collarbone, but it is unk whether this is occurring with stimulation or not. The pt is handicapped and cannot describe the pain very well. The migration did not occur near the time of implant at all. The pt experiences many bad falls associated with her seizures which the pt's family feels caused the generator migration. It was also reported that the pt will likely have surgery to address the migration at which time they will likely replace the generator prophylactically. Pt is "surgery shy", however, and is waiting to discuss with family whether to undergo surgery. X-rays were taken of the pt's device and sent to mfr for review. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1689573
« Last Edit: July 08, 2017, 11:15:38 PM by dennis100 » Logged
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« Reply #16 on: June 30, 2017, 07:47:25 AM »

Model Number 102
Event Date 08/01/2010
Event Type Injury
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the pt had surgery to remove the vns device due to infection and cellulitis. Pt went to er on (b)(6)2010 as her caregivers found the generator site had opened up (generator was visible) and was draining. Physician prescribed antibiotics. The device was removed (b)(6)2010 and the infection site was debrided and cleaned. The surgeon thought perhaps the pt's body had rejected the implant which caused the infection. However, per neurologist, the generator became loose and migrated slowly over 5 years to the pt's armpit, and came out. Once it was exposed to air, the infection started. It was also noted that the pt was likely manipulating the device which may have contributed to the events. Pt will be reimplanted in the future in a different location to prevent pt manipulation of the device. Explanted product was returned to the mfr and underwent analysis. Upon analysis, no anomalies were noted. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1833656
« Last Edit: July 08, 2017, 11:15:57 PM by dennis100 » Logged
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« Reply #17 on: July 04, 2017, 12:14:36 AM »

Model Number 102
Event Date 09/22/2010
Event Type Injury
Manufacturer Narrative
Conclusions - device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that high lead impedance was received at a follow-up appointment with the treating neurologist. The neurologist indicated through a clinic note that the pt's generator tends to shift position and migrate into the axilla. He states that it has made it hard to interrogate and adjust and also hard to use during seizures to try to stop seizures. The last known good system diagnostics per a clinic note were from (b)(6) 2010 and were ok/ok/2/no. The pt was referred for generator and lead replacement surgery due to both high impedance and migration of the generator. Pre-op system diagnostics showed 7/limit/high/no and the pt's settings were 1. 5/30/250/30/3. A company representative present at the time of surgery indicated that the generator was more difficult to locate due to the pt's large size and the generator's location under some breast tissue. However, once it was located, the company representative was able to interrogate it on the first attempt. The surgeon opened the chest pocket during surgery, took out the generator and a portion of the lead came out with it. Moreover, the generator was not secured down in the pocket and the lead looked to be twisted. The surgeon was of the opinion that since the generator was not sutured down, the pt was moving it around and twisting it ultimately breaking the lead. Surgeon elected to perform a full revision. The old leads were cut at the nerve. Outside of the pocket diagnostics with the new system resulted in ok impedance/1692 ohms/10yrs. Inside the pocket diagnostics resulted in ok impedance/1521 ohms/10yrs. Nonetheless, communication difficulties were still present with the new generator and were likely due to the pt's physique. Good faith attempts to obtain the explanted devices have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1867677
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« Reply #18 on: July 04, 2017, 07:34:27 AM »

Model
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« Reply #19 on: July 06, 2017, 05:01:57 AM »

Model Number 102
Event Date 11/11/2010
Event Type Injury
Event Description
Additional information was received on (b)(6) 2011 when clinic notes from the patient's physician were received. In the clinic notes dated (b)(6) 2011, the patient reported that not only had the generator become infected, but the lead also became infected and he had to have the lead explanted as well and go on more antibiotics. He reported that the infection was a (b)(6). Since the explant he reported that he has been having some dizziness and is unstable with ringing in his ears and dots in his vision and sometimes feel like he is going to black out. He also reports pain under his left axilla that goes down across his chest and stomach. Clinic notes dated (b)(6) 2011 revealed that the patient wants a vns re-implanted. Although surgery is likely, it has not yet occurred. Good faith attempts for additional information from the physician have been made but no further information has been received to date.

Event Description
Reporter indicated that his vns generator was explanted due to infection at the generator site in the chest, and the vns lead was left intact. The pt is currently on antibiotics for the infection. All attempts to the treating surgeon for further info have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
On (b)(6) 2011, additional information was received when the physician's assistant reported that the lead infection was first noticed on (b)(6) 2010 when the patient's family noticed a knot on the left side of neck and chest. The patient was told to go to the hospital for evaluation and the lead was removed around (b)(6) 2011. The patient was given iv antibiotics. The patient's family reported that the patient had had (b)(6). No patient manipulation or trauma had occurred that was believed to have caused or contributed to the infection. The physician's assistant did not know if it was the same infection as the infection at the generator site. He also was not aware that the patient was having any pain but said that it was probably related to the surgery and infection.

Event Description
Additional information was received on (b)(6) 2011 when the manufactures consultant reported that the patient had a neck exploration surgery that day to determine whether or not the patient would be reimplanted with vns. The surgeon decided not to implant a new vns system as he found that the vagus nerve was adhered with scar tissue to the internal jugular. The surgeon stated that he did not think it was possible to dissect the vagus from the internal jugular without damaging the internal jugular.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943766
« Last Edit: July 08, 2017, 11:16:59 PM by dennis100 » Logged
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« Reply #20 on: July 09, 2017, 09:22:54 AM »

Model Number 103
Event Date 11/01/2010
Event Type  Injury   
Event Description
Clinic notes reiceed reported that the patient had generator repositioning surgery on (b)(6) 2010. On (b)(6) 2014, system diagnostics were within normal limits with impedance value of 2826 ohms.
 
Event Description
It was reported that it is believed that a non-absorbable suture was used to secure the generator to the fascia during implant.
 
Event Description
It was reported by a company representative that a vns patient indicated her device was not working a couple of weeks after being implanted on (b)(6) 2010. The patient additionally reported her device had migrated under her armpit and reported she could no longer feel stimulation (unknown start date). The patient indicated that the device was working on (b)(6), and she would have voice alterations with stimulation. However, the patient stated that "one morning she woke up and noticed her device had moved". Over the next couple of days, she then noticed her voice no longer changed with stimulation and even tried using the magnet, but was unable to feel stimulation. Additional information was received through a company representative indicating the patient saw her treating physician and her device was working well on (b)(6) 2010. The treating nurse evaluated the patient and did not appear to be concerned with the patient's events, however, the patient was scheduled to see her treating neurologist. Further information from a company representative revealed the patient's device was fine and was scheduled to have vns repositioned.
 
Manufacturer Narrative
Date of this report, corrected data: the initial report inadvertently reported this data incorrectly. The initial aware date was (b)(6) 2010. Suspect medical device lot #, corrected data: the initial report inadvertently did not report this data. Date received by manufacturer, corrected data: the initial report inadvertently reported this data incorrectly. The initial aware date was (b)(6) 2010.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936653
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« Reply #21 on: July 13, 2017, 03:21:13 AM »

Model Number 102
Event Date 09/23/2008
Event Type  Injury   
Event Description
It was reported that a vns patient's device had migrated under her armpit due to unknown reason. No fall or injury preceding migration event was reported. Further information was received from a company representative indicating the patient was recently re-evaluated by her treating physician. Patient was concerned with her device migrating as the patient had been cleaning her fridge vigorously and the suture may have ripped at this point. Patient at this time wants to at least have her generator re-sutured down in the pocket site. However, at the time no additional information has been received indicating a schedule date for the intervention.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1924674

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« Reply #22 on: July 29, 2017, 09:17:22 AM »

Model Number 102
Event Date 04/25/2011
Event Type  Injury   
Event Description
It was reported that a patient had an episode of intermittent esophageal pain that lasted several hours. The generator's normal mode output was disabled, although the magnet output was left programmed. The patient did complain of pain when using the magnet. Diagnostic testing on (b)(6) 2009 showed the device to be properly functioning. Furthermore, the patient's generator was reported to be able to move around in her chest. Follow-up from the patient's physician at the time revealed that the site would not provide any more information on the subjects. However, at a later date it was indicated that the patient had her generator removed due to "pain" in her axilla region, though a migration event could not be confirmed. Additional information from the patient's surgeon's office stated the patient "complained of pain in the axilla and numbness in the left arm from the generator when lying on her left side". Clinic notes from the neurologist indicated that he did not believe the vns was causing left arm numbness. Analysis on the returned generator showed that the septum was not returned, but no evidence of body fluids were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098578
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« Reply #23 on: July 29, 2017, 09:18:01 AM »

Model Number MODEL 250
Event Date 04/19/2011
Event Type  Malfunction   
Event Description
It was reported that the patient was experiencing an increase in seizures with an unknown relationship to the pre-vns baseline and was experiencing painful stimulation underneath his armpit. Diagnostics taken indicated normal device function; however, the generator was at or near end of service. A rough battery life calculation was performed using dates from 10/09/2002 to 12/27/2006 that confirmed that the generator was likely at end of service. Upon interrogation of the patient's vns, it was found that a faulted diagnostics test had likely occurred, resulting in a change in the patient's settings. The physician indicated that the increase in seizures was likely a result of the decrease in settings. The patient's generator has been replaced due to end of service. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102253
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« Reply #24 on: July 29, 2017, 01:24:00 PM »

Model Number 103
Event Date 03/28/2011
Event Type  Injury   
Event Description
It was reported that the pt was experiencing painful and erratic stimulation in the neck. Pt says pain is at the generator site and up the lead to the neck, and is erratic and not just with stimulation. The physician programmed the pt's device off and took x-rays of the device. X-rays were not sent to the mfr for review. The physician feels that the generator has moved because he could not feel it in the past and can now clearly palpate the generator. Later info reveals that the generator had slipped into the armpit area. No trauma or manipulation has occurred. The pt was also experiencing an increase in seizures after the device was turned off due to loss of therapy. The pt underwent surgery to revise the generator pocket and secure the generator down. Diagnostics were all normal. The lead was also revised during surgery due to fluid being seen in the tubing (addressed in medwatch # 1644487-2011-01083). Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2096033
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« Reply #25 on: July 30, 2017, 04:45:39 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported that the pt was explanted today as she never really received much benefit from vns and she claimed the generator was uncomfortable. The surgeon removed the system and said that the generator was in the axillary area and he could see where it would be uncomfortable when lying on her side. It was also noted that the coils were placed upside down on the nerve with the anchor tether proximal to head. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2083049
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« Reply #26 on: August 03, 2017, 01:03:42 AM »

Model Number 300-20
Event Date 04/21/2011
Event Type  Malfunction   
Event Description
It was reported to the manufacture from a explanting physician in (b)(6) that he had a pt with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular area. It was reported that in the last 2 yrs, the pt had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 yrs due to battery exhaustion. The pt insisted on having their vns system explanted related to their pain events. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted her as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Therefore the entire lead body was not explanted. Their explanted generator was returned for analysis. In the product analysis laboratory it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator. Addressed in medwatch report number: 1644487-2011-01362. A portion of the pt's explanted lead was returned for analysis. There was a confirmed lead discontinuity. Note that a portion of the lead assembly (body), including the electrodes was not returned for analysis; therefore a complete eval could not be performed on the entire lead product. During the visual analysis of the returned 258mm portion the end of the marked connector quadfilar coil appeared to be broken approx 154mm from the connector bifurcation. Visual analysis was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unk if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The abraded openings found on the outer and inner silicon tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to their reported pain. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, and eval and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2194878
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« Reply #27 on: August 04, 2017, 05:53:55 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/29/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient began experiencing intermittent pain at the neck site in the neck in 2014. The patient has since reported in 2017 pain in her neck and in her chest and armpit area too, and wants the battery explanted. Clinic notes for surgical referral provided that the patient is requesting vns to be removed as she is having pain at the site of vns implantation up into her neck. The device has been off since 2015 she states she is unable to move her left arm above her chin level. The notes provided they were unable to palpate chest wall to check for vns placement due to pain as the patient moves away and refuses further examination. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695815
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« Reply #28 on: August 14, 2017, 02:57:11 AM »

Model Number 102
Event Date 08/11/2011
Event Type  Injury   
Event Description
It was reported that the pt's vns generator was scheduled to be replaced because it had migrated to the axilla. Diagnostics were within normal limits as per the physician. X-rays were taken to assess the condition of the vns lead however they will likely not be sent to the manufacturer for review. The pt was also noted as experiencing an increase in seizures that coincided with the generator moving beneath the armpit. The relationship of this increased seizure frequency to the pre-vns baseline frequency is unknown. Surgery to replace the pt's generator has occurred. It is believed that the migration is related to the previous surgeon not using a suture to secure the pt's generator properly. No trauma or manipulation was reported. Attempts for further info and return of the pt's explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2256562
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« Reply #29 on: August 15, 2017, 01:01:52 AM »

Model Number 102
Event Date 08/10/2011
Event Type  Injury   
Event Description
It was reported by a physician that a vns pt experienced her implant becoming more prominent over the lateral chest wall under the arm pit for the pat months. The pt had some chest trauma that could have had contributed to the event and is wearing supportive clothing for the moment. Additional info was received from a company rep indicating that the pt underwent generator reposition. The generator was re-sited medially and superior to the previous position below the clavicle. Moreover, info from the surgeon revealed that the believed cause for the migration was due to a chronic infection / immune response. Good faith attempts to obtain additional info have been unsuccessful to date.
 
Manufacturer Narrative
Device mfg records were reviewed. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2249200
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« Reply #30 on: September 03, 2017, 01:17:06 AM »

Model Number 103
Event Date 12/13/2011
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns implanting surgeon's nurse reported that the vns patient was complaining of pain in the left axillary/pectoral area and stating that the vns moves occasionally. The patient has had physical therapy to see if it would help with the discomfort but it did not. The patient was going to have surgery to either reposition or replace the battery. The nurse stated that the patient first reported the pain on (b)(6) 2011. The patient had surgery on (b)(6) 2012 and the surgeon just repositioned the generator and did not replace it. The operation notes from the surgery reveal that the patient has been experiencing this pain at the generator site over the past several months. The pain was exacerbated by movement at her shoulder. The surgeon stated that x-rays showed no evidence of malposition or break in the wire and that diagnostics show no evidence of functional problems. Because of the pain, the patient underwent reposition of the generator. After the generator was repositioned, diagnostics were still within normal limits. Attempts for additional information from the surgeon were made but no further information has been received to date. The implanted product information has been requested from the hospital but has not been received.
 
Manufacturer Narrative
Additional information was received regarding the product information therefore updating the information reported on the initial report.
 
Event Description
On (b)(6) 2012 the patient's implanted product information was received from the medical records department of the hospital the patient was implanted in.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2468877
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« Reply #31 on: September 18, 2017, 12:13:48 AM »

Model Number 103
Event Date 04/27/2012
Event Type  Injury   
Event Description
It was initially reported that the patient had their generator explanted due to an infection. The patient was recently implanted and the infection was likely related to surgery. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Good faith attempts for more information have been unsuccessful to date.
 
Event Description
Additional information was received that the infection was at the armpit and not where the generator was placed. There was no patient manipulation or trauma that contributed to the infection. Cultures were taken and results showed that they were pseudomonas species. They are planning to re-implant the patient but have not to date. Product analysis was completed on the generator. The device was returned due no malfunction suspected/identified and infection. Results of diagnostic testing indicated the device was operating properly and communicated properly. 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.
 
Event Description
Additional information was received indicating the patient's culture results indicated gram negative bacteria. The bacteria originated from the armpit area. The patient had been put on cipro as intervention. The patient was indicated is now doing "fine" per the surgeon. Surgery to reimplant the patient with vns has occurred.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2613729
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« Reply #32 on: September 20, 2017, 01:15:16 AM »

Model Number 103
Event Date 06/22/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's generator had migrated, and she was being referred for surgery. The patient was implanted with vns on (b)(6) 2012. Clinic notes dated (b)(6) 2012 indicated that generator had moved under the axillary region causing pain, pressure in the arm, and discomfort. The pain was indicated to be with movement. It was written that the patient would be referred to the surgeon to evaluate vns placement and make changes as needed. Additional information was received from the neurosurgeon after surgery consult revealing that the patient is experiencing numbness to the left arm due to the generator; moving around; the patient had generator replacement surgery on (b)(6) 2012 due to the generator migration. Attempts for product return have been unsuccessful to date. Attempts for additional information from the treating neurologist and implanting physician have been unsuccessful thus far. Additional information was however received on (b)(6) 2012 from the surgeon that performed the generator replacement which revealed that the migration caused the left arm pain and numbness. It was not believed the numbness was related to stimulation. It was not noted in the operative notes if the explanted generator appeared sutured down during generator replacement. However, it was confirmed that the replacement generator was secured to the pectoral muscle. The migration became symptomatic and quite painful before surgery for the patient which is why the patient had surgery. There was no indication of patient manipulation or trauma. No additional information was provided.
 
Event Description
It was reported that the explanted generator will not be returned for analysis, as the explanting facility requires patient signed release and they will not ask the patient at time of surgery, so therefore, this site will not return to manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662284
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« Reply #33 on: September 21, 2017, 12:34:03 AM »

Model Number 102
Event Date 06/13/2012
Event Type  Injury   
Manufacturer Narrative
Initial reporter, corrected data: the initial mdr report inadvertently listed the incorrect initial reporter. The correct reporter and occupation are provided.
 
Event Description
Reporter indicated a patient was experiencing migration of the vns generator into the left axilla, along with painful vns stimulation in the chest. The migration occurred approximately (b)(6) 2012. The patient has also reported the vns lead was migrating, but the reporter confirmed only the generator was migrating. It was also reported the generator was at end of service. However, a battery estimate performed yielded 4 years remaining, indicating end of service is unlikely. The patient had no trauma and did not manipulate the vns. The vns generator was secured with a non-absorbable suture at the initial implant surgery on (b)(6) 2007. Surgery to replace the vns generator is tentatively planned for (b)(6) 2012. Attempts for further information are in progress.
 
Event Description
A manufacturer's implant card was received from the reporter indicating that vns device diagnostics were within normal limits with the resident lead and new vns generator at the (b)(6) 2012 surgery. The implant card indicated the generator was replaced for prophylactic reasons.
 
Event Description
Reporter indicated the patient was having some left pectoral pain, but this was not considered a serious injury. It was felt the generator had migrated over the previous 3-4 weeks. The patient had generator replacement surgery performed on (b)(6) 2012. Attempts for return of the explanted generator have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional manufacturer follow up with the hospital revealed the explanted vns generator was discarded after the surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2648409
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« Reply #34 on: October 11, 2017, 02:12:14 AM »

Model Number 102
Event Date 03/06/2013
Event Type Injury
Event Description
It was reported that the patient was hospitalized on (b)(6) 2012 to receive iv antibiotics due to an infection at the generator site. The patient had undergone generator replacement surgery on (b)(6) 2013. The generator was explanted on (b)(6) 2013 due to the infection. It was noted that wound cultures showed rare staphylococcus aureus and that blood cultures showed no growth for five days. The patient was discharged home on (b)(6) 2013 in stable condition on antibiotics. The patient was referred to an infectious disease physician. The surgeon plans to reimplant a new generator when the infection is cleared. It is unknown if there was any patient manipulation or trauma that occurred that could have caused or contributed to the infection. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Further follow-up revealed that the patient was swollen in the axilla and neck area and as a precaution the patient was admitted to the hospital on (b)(6) 2013 for iv antibiotics. The physician indicated that at this time there was no obvious signs of infection at the site. The patient was then readmitted to the hospital on (b)(6) 2013 with signs of infection and both generator and lead were then explanted. The physician indicated that the patient scratched at the site which could have caused or contributed to the infection.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3038987
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« Reply #35 on: October 11, 2017, 02:13:44 AM »

Model Number 103
Event Date 03/12/2013
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that this vns patient required a lead revision for an unknown reason. Follow-up showed that the surgery was for repositioning of the lead. During surgery on (b)(6) 2013, the patient's generator was in the axillary position and moved to chest area. It is unknown where in the chest the device was initially implanted. Attempts for additional information have been unsuccessful.

Manufacturer Narrative
Corrected data: previously submitted mdr indicated the patient was the operator of the device. Additional information was received indicating that the physician may have contributed to the error. This report is being submitted to correct this data.

Event Description
Additional information was received indicting that the patient was referred for surgery due to pain/pinching in her axillary area. It is unknown exactly when this began. The surgery was for patient comfort. No patient manipulation or trauma occurred that is believed to have caused/contributed to the event. A non-absorbable suture was not used to secure the generator to fascia during implantation of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3043572
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« Reply #36 on: October 16, 2017, 12:20:55 AM »

Model Number 103
Event Date 01/31/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the vns patient¿s vns generator migrated down into her armpit. It was later reported that the migration was noticed shortly after the patient¿s implant, approximately nine months ago. Surgery is planned but has not occurred to date to fix the migration issue. Diagnostics were performed on (b)(6) 2013 and the physician reported that the device seemed to be functioning properly. No patient manipulation or trauma was reported. At this point it is unknown if non-absorbable sutures were used to secure the generator to fascia during implantation. Good faith attempts were performed and it was later reported that the migration of the vns generator was first observed on (b)(6) 2013. No patient manipulation or trauma is believed to have caused the migration. However, it is still unknown at this point if non-absorbable sutures were used to secure the generator to fascia during implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3241521
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« Reply #37 on: October 18, 2017, 12:31:44 AM »

Model
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« Reply #38 on: October 23, 2017, 12:50:42 AM »

Model Number 102
Event Date 10/15/2013
Event Type Injury
Event Description
Generator analysis was approved on (b)(6) 2013. The pulse generator was explanted/returned due to ¿prophylactic replacement¿. The reported ¿failure to program¿ allegation was duplicated (not due to eos) in the pa laboratory at two orientations. Repositioning the wand resolved, and this it is not considered a device malfunction. In the pa 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2013, this vns patient underwent prophylactic generator revision. The patient reported an increase in seizures, and the patient¿s neurologist was not able to interrogate the device. The device was believed to be at end of service, and the patient was referred for surgery. The patient had gained weight. The device could be programmed and interrogated successfully on the date of explant. Follow-up showed that the device was changed because it had migrated into the axilla. The device couldn't be interrogated due to the patient's habitus, and she could not tolerate prolonged searching secondary to her psychiatric problems. The most recent settings as of (b)(6) 2013 were provided. The physician stated that the failure to program occurred on (b)(6) "2031", and the physician was unable to do a normal mode test. This would not process. The vns was also very slow to interrogate. This was possibly caused by physical location of the vns. The generator was returned on (b)(6) 2013 and is pending analysis. An in-house battery life calculation showed 5. 63 years remaining.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3488430
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« Reply #39 on: October 23, 2017, 12:51:20 AM »

Model Number 103
Event Date 08/07/2013
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that the patient's vns device was removed because the patient began having more frequent seizures after the vns was turned on. The patient did a trial with the vns device turned off and only had one seizures. The vns also caused discomfort in the left axilla. The patient and family wanted the device removed. The patient did very well post-op. Follow up with the physician found that they are reluctant to provide any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462536
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« Reply #40 on: October 26, 2017, 12:40:39 AM »

Model Number 105
Device Problem Migration of device or device component
Event Date 01/19/2014
Event Type Injury
Event Description
It was reported that the patient experienced fever and redness over the generator. The patient was seen and admitted for iv antibiotics. It was reported that the generator had migrated across the chest wall to the anterior axillary fold and that the skin was inflamed. It was reported that the patient had undergone generator replacement in (b)(6) 2013. It was reported that the patient would likely undergo surgical exploration. Further follow-up revealed that swabs taken have come back negative to infection. It was reported that the generator was removed and the wound was washed out and debrided. It was reported that the lead was buried in the wound and sutured in place. A non-absorbable suture was reportedly utilized to secure the generator during initial implant surgery. It was reported that the micro analysis is underway, but that it is highly likely infection.

Event Description
Additional information was received that no infection was found following first removal of device removed (b)(6) 2014.

Event Description
The generator was received for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
An implant card was received indicating that the patient underwent generator implant on (b)(6) 2014.

Event Description
It was reported that there are no signs of infection and that reimplant is being planned.

Manufacturer Narrative
Review of device manufacturing records. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3632721
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« Reply #41 on: November 03, 2017, 02:49:54 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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« Reply #42 on: November 11, 2017, 02:49:16 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2017
Event Type Injury
Event Description
Clinic notes were received for generator replacement referral. Per notes, the patient reported that she feels her vns has been more painful lately, and wonders if it is not working any longer. At the previous clinic visit, she mentioned that her vns was not firing off for a couple hours (normally, she can feel it firing). It was reported to be working ok since then up until past two weeks, when she has been feeling pain in her left chest area, under her armpit, especially when the device fires. Patient also feels a wire present near the attachment to the device which was not noticeable to her previously. Patient has not had any injuries or falls which may have damaged the device. Patient compares this to a similar feeling she had before the batter was replaced previously. Patient's device was interrogated but no adjustments were made. The patient consulted with a surgeon who indicated that a generator replacement is recommended. The lead impedance was normal and so lead replacement is not needed. Impedance - 2424 ohms. The surgeon noted granulation tissue or lead wire close to the skin in the chest area. The incision was however well healed. No other relevant information was received. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6949677
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« Reply #43 on: November 14, 2017, 02:25:47 AM »

Model Number 103
Event Date 01/20/2015
Event Type Injury
Event Description
On (b)(6) 2015 the physician reported that the pain was first observed in (b)(6) 2014. No trauma or manipulation that preceded the onset of the pain. The intervention taken was that the generator was repositioned to the axilla.

Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a repositioning of the generator as the current position is painful. Good faith attempts for further information from the physician were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4513177
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« Reply #44 on: November 17, 2017, 03:44:19 AM »

Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Clinic notes dated (b)(6) 2013, indicate the patient was seen back that day "poset" chess abscess at the vns pocket. The patient is doing well and shows no signs of infection. Sutures were removed. Clinic notes dated (b)(6) 2013 indicate that there were complications with the vns implant surgery which led to the infection. The infection required vns removal. An analysis was performed on the returned lead portions. The slice mark found on the outer silicone most likely provided the leakage path for the remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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, with no discontinuities 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. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. The battery voltage was 2. 924 volts (not at ifi), as measured during completion of test parameter (b)(4) of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 1. 412% of the battery had been consumed. 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.

Event Description
It was reported that the patient was going to undergo explant of the vns system on (b)(6) 2013 due to infection. It was reported that the patient has been on antibiotics. Further follow-up revealed that the patient was admitted to the hospital for iv antibiotic therapy and did not respond as well as the surgeon preferred. Clinic notes dated (b)(6) 2013 indicated that the patient had a right chest abscess with cellulitis. It was noted that the patient was doing well until 3 days prior when he noticed that his chest area became red and swollen and tender to touch. The patient was seen in the emergency room on (b)(6) 2013 and was found to have pus draining from the chest site. The patient was given antibiotics and sent home. The patient was seen by the physician on (b)(6) 2013 and a culture and sensitivity and gram stain were obtained. The gram strain was negative and the patient was admitted to the hospital for further antibiotic therapy. It was noted that the patient had bloody material draining from the wound at the anterior axilla region. The generator and lead were returned for analysis on 11/05/2013. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479210
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« Reply #45 on: November 22, 2017, 03:24:30 AM »

Model Number 102
Device Problems High impedance; Migration of device or device component
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient's generator had migrated from its original position to the patient's armpit whenever she moved in a certain way. The patient was seen by the physician and referred for surgery to correct the migration of the device. The physician noted that the generator does shift significantly under the skin in the left pectoral region. Manipulation of the pulse generator causes significant discomfort to patient in the chest and also some hoarseness of the voice. Additional information was received that no trauma or manipulation is suspected. Diagnostics were reported to be within normal limits with no high impedance. Patient underwent full revision surgery on (b)(6) 2015. Diagnostics were attempted but patient experienced left neck pain and coughing with stimulation. Upon opening generator pocket the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead as well (reported in manufacturer report # 1644487-2015-04810). Upon opening the neck incision, surgeon noted that there was not adequate strain relief from the implant surgery and this caused "pulling and twisting" of the nerve. Both the generator and lead were replaced and post replacement diagnostics were within normal limits. The explanted generator is expected to be returned but has not yet been received by the manufacturer.

Manufacturer Narrative

Event Description
It was reported the hospital was able to find the explanted generator. The explanted generator was received by the manufacturer on 08/14/2015. Analysis is underway, but has not been completed to date. The explanted lead is captured in mfr. Report # 1644487-2015-04810.

Event Description
Additional information was received from the explant facility that the explanted products will not be returned.

Event Description
A user facility medwatch report (uf/importer report # (b)(4)) was received stating that the device was "shocking" the patient.

Event Description
Additional information was received that the patient continues to experience pain in the chest due to the presence of scar tissue. The physician noted a small area of prominence that follows in the path where the previously explanted lead was present. The physician felt the presence of possible scar tissue, and attributed this to patient's sensitivity and pain. The physician further attributed the presence of scar tissue to the corrosion of the explanted lead and the previous revision surgery. Physical therapy was recommended by the physician for the breakdown of scar tissue and for pain. The report of corrosion on the lead was previously reported in manufacturer report # 1644487-2015-04810.

Manufacturer Narrative
Describe event or problem; corrected data: the information regarding the return of the lead was originally and inadvertently reported in mfr. Report # 1644487-2015-04809, supplemental report #03.

Event Description
It was reported the hospital was able to find the explanted lead. The explanted lead was received by the manufacturer on 08/14/2015. Analysis is underway but has not been completed to date. New information was also received stating the voice hoarseness the patient experienced was sometimes caused by stimulation.

Manufacturer Narrative
The supplemental 04 mfr report was stated to be 09/13/2014. This was mistakenly reported and the actual date was 09/13/2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808411
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« Reply #46 on: November 25, 2017, 08:13:12 AM »

Model Number 105
Device Problem Size incorrect for patient
Event Date 07/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the explanted device was discarded and will not be returned for analysis.

Manufacturer Narrative
(b)(4).

Event Description
On (b)(6) 2015 it was reported that the patient was re-implanted with a model 103 due to patient discomfort. Attempts have been made for the explanted generator but the device has not been received to date.

Event Description
It was reported on (b)(6) 2015 that the patient had a replacement with a model 105 generator in (b)(6) and is now complaining that the generator is too big. The patient states that she is uncomfortable and that it presses into her armpit. The patient wants the device replaced with a smaller model. It was noted that her md does not agree with this because she is receiving good seizure control, but did refer her to a surgeon for consult. No surgical intervention has been taken or planned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5016030
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« Reply #47 on: December 01, 2017, 02:42:09 AM »

Model Number 102R
Device Problem Migration of device or device component
Event Date 10/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received stating that the patient underwent repositioning surgery on (b)(6) 2015. It was noted that surgery was not to preclude a serious injury to the patient but for patient comfort. The physician indicated that trauma most like had occurred which contributed to the reported event and confirmed that a non-absorbable suture was used for the initial implant procedure; however, the generator had rotated 180 degrees around the suture.

Event Description
It was reported that the vns patient's device had migrated under the armpit. The patient was scheduled for repositioning 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=5179328
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« Reply #48 on: December 05, 2017, 01:48:51 AM »

Model Number 103
Event Date 10/22/2015
Event Type Injury
Event Description
New information was received stating that the patient underwent a generator explant and replacement. Follow up with the treating neurologist indicated that he believed the inability to communicate with the device was due to the migration of the generator. The neurologist stated that he does not believe the lead was replaced and indicated that the new generator is functioning properly. Requests for additional relevant information from the surgeon have been unsuccessful to date. Requests to obtain the explanted generator for product analysis have been unsuccessful to date.

Event Description
It was confirmed that only the patient's generator was replaced during the surgery due to migration. Product return attempts have been unsuccessful to date.

Event Description
It was reported that the vns patient was referred for surgery as the patient's device was unable to be interrogated due to end of service. A battery life calculation using the available programming history showed - 10 years remaining. Follow-up revealed that the patient's device had migrated deep into the armpit of the patient and that the device was unable to be interrogated. It was noted that the patient's device was always difficult to locate. The physician's office stated that it was unknown if the device was actually at end of service. Trauma or any other external/contextual factors were not believed to have caused or contributed to the event. It is unknown whether a non-absorbable suture was used to secure the generator. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5249128
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« Reply #49 on: December 05, 2017, 01:49:47 AM »

Model Number 103
Device Problems Loss of or failure to bond; Migration of device or device component; Material Protrusion Event Date 04/07/2015
Event Type Injury
Event Description
It was reported that the vns patient's generator had migrated under her armpit a few weeks ago and causing pain at the generator site. The generator later moved back to the original implant site but it was noted that leads were protruding at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to reposition the device. During the procedure, the surgeon did not observe a suture securing the lead. Patient manipulation or trauma is not believed to have caused or contributed to the event.

Event Description
It was reported that the vns patient continued that have issues following repositioning surgery. The patient stated that her neck area was still tight and painful. She described the issue had started as a small lump in her throat but then became ¿the size of a golf ball¿ that caused pain when eating, swallowing, or moving her neck/throat. Follow-up with the surgeon¿s office revealed that the patient had a post-operative appointment on (b)(6) 2015, and no issues were noted at the patient¿s neck region. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5253695
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« Reply #50 on: December 06, 2017, 02:53:02 AM »

Model Number 103
Device Problems Migration of device or device component; No Known Device Problem
Event Date 12/04/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient fell during a seizure that was caused by stress and hit her neck on a table. The patient reported that her generator migrated up towards her collarbone. The company representative saw that the generator was in a position that is commonly placed by surgeons. The patient did have a large bruise on her neck, from under the chin down to the bottom of the neck. Diagnostics were performed, which were within normal limits. X-rays were performed, and they showed that the generator was situated near the left armpit of the patient. The surgeon who placed the generator saw the x-rays, and he stated that the generator was in a place that would be considered normal for how he implants generators. The patient did have a circular bruise about 2 inches more medial than where the generator was observed to be in the x-rays. The location of the bruise is where the patient claimed that the generator was prior to the fall. The patient was referred for revision surgery to ensure the correct placement of the generator. No surgical intervention has occurred to date. Attempts for further information were unsuccessful to date.

Event Description
Clinic notes were received for the patient's appointment with the physician. The patient's generator was displaced and was painful, causing the patient to have reduced ability to mover her left shoulder and arm. The physician stated that the displacement was traumatic (due to a fall from the year before), and the pain in the left armpit and chest started the past few months. The patient also could feel the generator moving towards the axilla. The physician noted that the lead was not prominent before, but now he could see the lead clearly as it was being pulled on by the generator migration. The physician referred the patient for surgery to get a new generator and fix the migration. No surgical intervention has occurred to date.

Event Description
The physician did believe that the cause of the bruise was from the generator being displaced laterally from the fall. Pocket revision surgery was planned due to the migration of the generator. However, the patient saw her neurologist again instead of going to see the surgeon. The neurologist decided that the generator was in a normal position, which was previously confirmed by the surgeon, and would not require surgery.

Event Description
The patient had generator replacement surgery due to migration/pain. The device was explanted by the hospital. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5337448
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« Reply #51 on: December 07, 2017, 02:04:59 AM »

Model Number 106
Device Problem No Information
Event Date 12/11/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Follow up communication indicated that the patient's generator was actually implanted in her left armpit. Additionally, it was indicated that the patient was a regular smoker. This was the same location that her previous generator was located. No additional pertinent information has been received to date.

Event Description
It was reported that the patient developed a post-surgical infection. The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics. The symptoms of infection had reportedly resolved at that time. Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm. The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis. No interventions for the thrombophlebitis have occurred. The patient was not admitted to the hospital. The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm. A review of device history records showed that the generator was sterilized 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=5397383
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« Reply #52 on: December 08, 2017, 11:26:46 PM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/26/2017
Event Type Injury
Manufacturer Narrative

Event Description
Patient's vns is migrating and causing her a lot of discomfort. The patient has been seizure free but she would like to change the location of her device as it is kind of painful under her left arm pit. No known surgical interventions have occurred to date. No other relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042673
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« Reply #53 on: December 09, 2017, 01:38:23 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/04/2017
Event Type Injury
Event Description
Report received from clinic notes that a patient was seen in the clinic and her generator was easily palpable in the left chest and axilla. The generator was reportedly extremely mobile and could be flipped over under the skin from side to side. Further information was received that the patient was scheduled to get a generator replacement with the intention of providing the patient with a new generator and correcting the migrated device at the same time. The patient's current generator battery was reportedly depleting, so the neurologist indicated it would be good to replace the device. It was also reported that the migration was needed because there was concern that the flipping of the generator would damage the lead wire. No surgical intervention has occurred to date and no further relevant information has been received.

Manufacturer Narrative
Device evaluation is not necessary because the reported event of migration has been determined to not be related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6993054
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« Reply #54 on: December 11, 2017, 03:11:02 AM »

Model Number 304-20
Event Date 01/01/2016
Event Type Injury
Manufacturer Narrative
Information received the day the initial mdr was submitted was inadvertently omitted from the initial mdr.

Event Description
The patient was set to have surgery but it was determined that no replacement of the generator was necessary. The leads were manipulated and it was stated that the device seems to be ok. Clarification from the nurse was obtained which showed that the reason for the planned replacement was solely for the patient's neck pain. There was no chest pain, only pain in the neck area of the vns. She confirmed the battery was still good and impedance levels were fine. The surgeon also took some x-rays and determined the positioning of the tie-down (or what they called the elastic flange) was likely causing her discomfort against the skin. She stated that they dissected the flange out and because there was enough scarring around the lead they did not need to secure it again. The procedure was for patient comfort.

Manufacturer Narrative

Event Description
Notes dated (b)(6) 2016 state that the patient's battery is reported to be near end of service and requires replacement. Notes dated (b)(6) 2016 state that one week prior the patient had onset of shooting pain in her left axilla. The notes state that the patient was seen urgently by the neurosurgeon upon complaints of pain/discomfort of concern for vns malfunctioning. Noted to have protruding piece of chest wall tissue of concern for a surgical clip vs wire/generator attachment. Vns was interrogated and found to have normal impedance. Chest wall protrusion of concern for adhesions that may be contributing to muscular skeletal discomfort. The vns was turned off for 20-30 minutes and then turned back on, patient was observed during this time for side effects/adverse effects and no discomfort was noted. It was indicated that on (b)(6) 2016 the patient had surgery. The generator was not changed but it was indicated that something was done to the leads although it is not clear at this time what they did. Post-op impedance was still within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5435350
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« Reply #55 on: December 13, 2017, 02:33:49 AM »

Model Number 103
Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Analysis of the generator was completed on 03/21/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Pre-operative diagnostics performed prior to surgery for the generator migration identified high impedance (7335 ohms). Both the lead and generator were replaced. The generator and lead were received for analysis. Analysis of the lead was completed on 03/07/2016. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, anchor tether and the (-) green electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 230mm portion quadfilar coil 1 appeared to be broken approximately 21mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded open / torn area found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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 other discontinuities were identified.

Event Description
It was reported that the patient was referred for surgery due to the generator migrating under the patient's armpit and causing pain. It was reported that the patient is developmentally delayed and patient manipulation is suspected. The physician reported that the generator replacement was being performed to preclude a serious injury. It was reported that the patient was experiencing breakthrough seizures and there is concern that the vns is not working as effectively as it was before which is why the generator will be replaced when the revision surgery occurs. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5402897
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« Reply #56 on: December 31, 2017, 02:37:24 AM »

Event Type Malfunction
Event Description
It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device. The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping. The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps. Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns. However, the patient refused to be re-implanted after the third generator was explanted. The patient kept the third generator after explant, and the lead was left implanted. The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices. " he tried to hurt himself as well because of the painful stimulation and distress. No further relevant information has been received to date.

Manufacturer Narrative

Event Description
The patient reported that his third generator malfunctioned and shocked his jaw and teeth to the point where he had to get dentures. He reported that he could not get the lead removed where he lived due to the damage on his nerve from stimulation. Neither of the patient's previous surgeons were aware of a third generator being implanted. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6031775
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« Reply #57 on: January 01, 2018, 02:44:08 AM »

Model Number 105
Event Date 10/13/2016
Event Type Injury
Event Description
The explanted generator and lead were received by the manufacturer for analysis. Product analysis is expected; however, it has not been completed to date.

Event Description
Product analysis (pa) for the returned generator and lead was completed. The allegation of infection was noted to be beyond the scope of the activities performed within the pa laboratory environment. However, potential contributing factors to this condition were considered/evaluated and none were found to exist. The generator diagnostics were as expected for the programmed parameters. The electrical test showed the generator performed according to functional specifications. There were no performance or any other types of adverse conditions found with the generator. Other than typical wear and explant related observations, no other anomalies were identified with the returned portion of the lead. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion.

Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had an infection, which was first observed, on (b)(6) 2016. The patient's family had noted on (b)(6) 2016, prior to a normal scheduled follow-up visit on (b)(6) 2016, that they had observed some swelling and the generator implant location. The infection was confirmed on (b)(6) 2016 at the follow-up appointment and the patient had a chest ultrasound due to the infection on (b)(6) 2016. The patient underwent a full explant surgery on (b)(6) 2016. It was noted prior to surgery on (b)(6) 2016 that there was actually wound dehiscence which had occurred between (b)(6) 2016 and the surgery date. It was noted the reason for the infection is believed to be the fact that the generator was implanted in the axillary region and the patient is in a wheelchair and the sweat may be a contributing factor to the cause of the infection. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6055616
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« Reply #58 on: January 05, 2018, 03:54:45 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/19/2016
Event Type Injury
Event Description
Further follow-up with the physician¿s office 03/06/2017 provided the patient had been scheduled for surgery. It was decided to perform the surgery after seeing the surgeon again and they were able to palpate it and find that it was moving after doing so. Generator replacement surgery occurred on (b)(6) 2017. The explanted device has not been received by the manufacturer to-date.

Event Description
Follow-up from the company representative provided that after the patient had been to see the surgeon, he had concluded the device has not migrated.

Event Description
It was reported to a company representative that a patient¿s generator is migrating down to the armpit and the patient has complained that it¿s painful near the muscle around the armpit area when it migrates. The physician took x-rays and it showed that it was in a normal location when the x-ray was taken but the patient can feel it moving if she pushed it and it was reported that the patient could flip the generator if she tried, although it was reported that she hasn¿t flipped it. The patient later reported that she saw the surgeon and is planning surgery to replace the battery and lead, stating that the device has migrated underneath her armpit area and with her work she gets pain in the generator site with movement. The pain is constant but increases when the device goes off. The pain will radiate up to the neck area and further to the jaw at time of stimulation. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6344391
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« Reply #59 on: January 06, 2018, 04:23:11 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 10/06/2004
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received and stated that the patient underwent vns surgery of her first implant but she had pain in the left axilla and arm. Therefore, the generator was relocated below the left clavicle and she continued to have problems with pain. The generator was then placed below the pectoral muscle without difficulties. The notes state vns stimulator insertion 2004/2006/2008 which the 2006, 2008 are likely the relocation surgeries. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7076570
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« Reply #60 on: January 07, 2018, 03:29:32 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/01/2017
Event Type Injury
Event Description
It was reported that the patient was experiencing discomfort at the generator implant site and was concerned that the generator had moved into her armpit. There was more discomfort noted when a shoulder seat belt and backpack straps were present. The generator was noted to be palpable sitting medially to the anterior axillary line incision. The patient was referred for surgery where the generator was going to be repositioned and potentially replaced. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.

Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7074866
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« Reply #61 on: January 09, 2018, 02:39:40 AM »

Model Number 102
Event Date 01/14/2009
Event Type Injury
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. X-rays reviewed by the manufacturer, migration of the generator was not able to be confirmed on the x-ray views received.

Event Description
It was reported to manufacturer that the treating vns physician saw the vns pt due to swelling in the left armpit and possible generator migration. X-rays were sent to manufacturer to review, and the migration event could not be confirmed as there were no baseline x-rays to compare them to. Diagnostic tests were performed following the onset of the reported event and revealed normal device function. Approximately a week later, the swelling appeared to be improving. Further info received revealed that the treating physician saw the pt again at a later date due to the continuation of the migration of the generator, which the pt believed was causing painful stimulation. Additionally, it was reported that the pt was experiencing an increase in seizure activity. The physician discussed with the pt, the possibility of surgical intervention. The pt then reported that she was seen by the primary care physician and stated that an infection was present, and that the swelling has gotten worse had moved down the left arm. The pt reported that antibiotics were prescribed. Additional info received from the treating vns physician's office revealed that the pt went to an emergency room and was treated with antibiotics and was subsequently released. The fever had resolved, and the swelling was improving. The vns device was disabled and they are continuing to monitor the pt. Good faith attempts to obtain additional info have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341924
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« Reply #62 on: January 09, 2018, 02:40:46 AM »

Model Number 102
Event Date 05/02/2011
Event Type Injury
Event Description
On (b)(6) 2011 a vns implanting surgeon reported that the vns pt wants to have her device explanted because she is experiencing a "voice tick", heart fluttering, coughing, and numbness on one side of cheek and throat. The pt had been implanted (b)(6) 2011. She was scheduled to see her nurse practitioner on (b)(6) 2011. On (b)(6) 2011 clinic notes dated (b)(6) 2011 from the vns treating nurse practitioner were received. The clinic notes report that the pt is experiencing an uncontrolled cough and clearing of the throat (worse with stress), pain at the vns generator site, numbness and tingling to chin through her left ear/facial, and was very nervous describing the increasing discomfort the vns has caused. The pt went for f/u with the surgeon and after the pt told him about the numbness and tingling he suggested immediate removal of the vns. The pt's medical history lists migraine headaches, esophageal reflux, and tia; it is unk the relationship of the events to vns. The pt's neurological exam showed headaches associated with dizziness and seizures and the pt feels like her device moves around from the chest area to under her armpit at times. The physician is referring the pt for vns removal and educated the pt about how some of her symptoms may be related to stress and not completely due to vns implant, since they were ongoing after the device was disabled that day. Good faith attempts for additional info from the pt's nurse practitioner have been to no avail thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103698
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« Reply #63 on: January 11, 2018, 02:21:15 AM »

Model Number 302-20
Event Date 08/08/2014
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 vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned 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=4103125
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« Reply #64 on: January 15, 2018, 02:22:22 AM »

Model Number 100
Event Date 12/04/2001
Event Type Injury
Event Description
It was reported that a patient underwent generator revision surgery due to vibrating pain that occurred in the left axilla during stimulation on times. Once the patient's device was replaced, the pain appeared to resolve. Good faith attempts to obtain additional information from the patient's treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1504664
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« Reply #65 on: February 04, 2018, 02:10:52 AM »

Model Number 102R
Event Date 03/31/2011
Event Type Injury
Event Description
On (b)(6) 2011, it was reported by a vns implanting surgeon to the case manager that the vns patient was seen on (b)(6) 2011, complaining of a "burning sensation" in her neck. The patient's generator had been recently replaced and the generator was placed in her axilla region instead of the clavicular region. The patient is having discomfort with the generator in her axilla region, especially when she sleeps at night, therefore, she was referred to the surgeon for repositioning of her generator. No diagnostics were performed. On (b)(6) 2011, the surgeon moved the patient's generator to just under the clavicle. However, the surgeon used electrocautery to open up the patient. The manufacturer's consultant was advised that there is a safety alert regarding the use of electrocautery with vns because it could possibly disable the generator or affect the battery life. The consultant was informed that he needed to review the safety alert with the surgeon. It was reported that they were able to communicate with the generator and everything was fine after the surgery. Good faith attempts for further information from the patient's physician have been to no avail thus far. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2070197
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« Reply #66 on: February 06, 2018, 02:26:34 AM »

Model Number 102R
Event Date 04/14/2011
Event Type Injury
Event Description
Reporter indicated the patient developed seromas in the chest and neck that later developed into abscesses, which is why the patient's vns was explanted. The events are felt to be related to trauma to the arms and neck by the patient's attendants while repeatedly moving the patient. The patient is recovering satisfactorily from the explant surgery. Analysis of the explanted vns generator was completed. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator shows no evidence of bodily fluid remnants in the case/header areas. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Event Description
Reporter indicated that a patient presented on (b)(6) 2011 with vns generator migration to the axilla along with generator extrusion through the skin. No infection was present. It was unknown what caused the migration or generator extrusion to occur, or if anything precipitated the events. It is not known if the patient had any trauma or if device manipulation occurred. The patient is developmentally delayed. The generator was surgically repositioned on (b)(6) 2011 in a new pocket under the pectoralis muscle and was secured to the fascia with a silk suture. No devices were explanted. The patient was also given antibiotics and is healing well.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the device manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported on (b)(6) 2012, by a caregiver to the manufacturer that the vns patient had surgery on (b)(6) 2011, due to generator migration, infection and wound dehiscence at the generator site. The patient recovered per the caregiver until (b)(6) 2012, when it was noted there was swelling and redness along the vns lead wire in the neck area. On (b)(6) 2012, the patient had surgery to debride the neck area, and the patient was given antibiotics. The wound was also packed daily with gauze. 8 weeks after the surgery the wound opened up and the patient was again put on antibiotics. It was previously reported by the treating surgeon that no infection was present at the generator site at the time of surgery on (b)(6) 2011, but wound dehiscence and migration at the generator site had occurred. Clinic notes were also received from the treating surgeon documenting the neck abscess/dehiscence reported by the caregiver, and that cultures of the neck wound site noted rare (b)(6) bacteria. The patient had developed a neck abscess that had healed, but subsequently opened up recently and was very superficial. The area was cauterized with silver nitrate. The patient was also on oral antibiotics. The patient also has a chest seroma in the area of the vns generator that may be due to trauma, and is being watched for now. Additional manufacturer follow-up with the treating surgeon revealed the neck abscess/dehiscence was felt to be due to trauma and patient manipulation. No medication changes contributed to the events, and no additional interventions have been performed for the neck abscess/dehiscence or chest seroma. The patient is recovering per the surgeon.

Event Description
Reporter indicated the patient may be reimplanted with the vns in the future, but no surgery has been scheduled to date. The vns has been helpful for the patient's seizures in the past per the reporter.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated the patient would have vns lead and generator explant surgery due to infection at the left chest generator site. Prior to the surgery, it was noted on (b)(6) 2012 that the chest wound was opened. The patient had developed seromas of the neck and chest over the last year, which were opened up and packed. The seromas had abscesses. The neck wound had recently healed. The chest wound was packed with nu gauze, and the patient was to continue daily wound packing. The patient later had generator and lead explant surgery performed on (b)(6) 2012. No new devices were implanted. The generator only was returned and is pending analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098698
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« Reply #67 on: February 15, 2018, 02:28:34 AM »

Model Number 103
Event Date 09/01/2011
Event Type Malfunction
Event Description
Product analysis of the explanted generator has been completed. Results of diagnostic testing indicated that the device was operating properly and communicated properly. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications.

Event Description
It was initially reported that the patient that after losing (b)(6) lbs. Intentionally, she feels like her generator has migrated to her armpit. The patient is also having severe headaches on the left side and has been experiencing them for the past (b)(6). The pain in intermittent and feels like it is occurring when the device stimulations. The pain is sharp and does not resolve with medication treatment. The patient was instructed to follow up with her physician. Later information was received indicating that the headaches resolved when the magnet was used to disable the device. The patient is going to be referred to a surgeon for the migration. The pain was quite significant in that the patient had absolutely no relief unless the magnet was secured over the generator site however then the patient ran the risk of not getting the therapy. The reason they believed the device was malfunctioning was because the patient did not have these headaches before and the pain began rather quickly and worsened only to improve when the device was disabled with the magnet. There were no medication changes or other factors preceding the onset of the headaches. There were no reports of trauma either. The generator was replaced and the patient has been doing well since replacement with no further pain. The explanted generator has been returned to the manufacturer and is currently undergoing product analysis.

Event Description
Additional information received revealed that 3-0 vicryl sutures were used to secure the generator to the fascia during implant on (b)(6) 2010.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341941
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« Reply #68 on: February 17, 2018, 04:36:12 AM »

Model Number 300-30
Event Date 12/02/2011
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2011, were received from case management which revealed that the patient had experienced chest pain for the past (b)(6) months, which radiated down her axilla and arm. The patient has had catamenial seizures affecting her right arm since age fifteen. She has had spells of right arm stiffening two years prior to her first generalized tonic-clonic seizure at age (b)(6). It was reported that vns has "reduced her seizures from daily to only associated with menses. " the patient was seen on (b)(6) 2011, on an urgent basis due to a new onset of headaches that required hospitalization, as well as seizures. The patient's seizures have been variable over the years from five seizures per day, to as many as twenty per day (30% during wakefulness and 70% waking her from her sleep), especially during ovulation and onset of menses. However prior to vns, she had them outside her menses as well. The patient experiences multiple focal seizures around her menses. The patient's chest pain is described as sharp affecting the lateral and posterior region of her left chest. However, palpation does not recreate pain, rather, the pain is created by stretching. The patient takes hydrocodone and ibuprofen for the left chest pain. The patient was concerned that vns may be causing the pain. Further more, the patient called the physician on (b)(6) 2011, as documented in the clinic notes because she was having chest pain and went to a cardiologist who alleged that she has a "broken wire" in her vns. The patient reported that the cardiologist felt around it and stated that he "felt a pulse where it was broken. " the patient reported that the pain was so bad, when she got home that she took a percocet, but the pain still persisted around her heart area, left axilla, and down her left arm to her hand. The patient wanted to know what to do because the pain was progressing. The patient was referred for a stat chest x-ray to check the leads. However, no lead breaks were noticed by the physician during a review of the x-rays. The patient was prescribed percocet. The patient was also referred for a consult with a surgeon for a new generator or vns adjustment. The x-rays were not sent to the manufacturer for analysis. The patient had generator replacement surgery on (b)(6) 2011. Attempts for additional information from the patient's neurologist's office have been unsuccessful thus far. The reason for generator replacement is not known at this time. The diagnostics performed on (b)(6) 2011, did not indicate that there was a device malfunction. A batter life calculation was performed with the history available in the in-house programming database, and the results were approximately 3. 91 years until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2387860
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« Reply #69 on: March 08, 2018, 09:43:53 AM »

Model Number 302-20
Event Date 09/08/2010
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history. Device failure is suspected but did not cause or contribute to a death or serious injury.

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. Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".

Event Description
Attempts for additional information have been unsuccessful to date.

Event Description
The explanted lead and generator were returned and underwent analysis. An implant card and returned product form were received indicating the reason for replacement was lead discontinuity. The entire lead was not returned. No anomalies were observed in the returned lead portions except two abraded openings in the outer tubing. Analysis of the generator found it performed to functional specifications.

Event Description
It was reported that the patient's vns was now indicating high impedance. The patient's mother indicated that the patient's generator is implanted underneath his armpit due to his young age. The mother indicated that the patient roughhoused on occasion and they also frequently picked the patient up from under his armpits. Per the mother, the patient had been experiencing an increase in seizures below the pre-vns baseline seizure frequency since (b)(6) 2011. The magnet no longer was aborting seizures and the patient's voice no longer changed with stimulation around this time as well. No x-rays have been taken to evaluate for a lead fracture. The device has reportedly not been disabled as recommended in manufacturer labeling. Review of the programming history available to the manufacturer found that the lead impedance was normal on (b)(6) 2010 at 2900 ohms however, a significant change in impedance occurred on (b)(6) 2010 when the impedance changed from 5386 ohms to 2700ohms. This could be indicative of an intermittent lead issue beginning at that time eventually developing into the current issue. Surgery to replace the patient's lead and generator has occurred. Attempts for the return of the explanted products and for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2596398
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« Reply #70 on: March 09, 2018, 03:29:12 AM »

Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type Injury
Event Description
It was reported that the patient was referred for vns repositioning surgery due to severe pain around her neck and chest region and muscle spasms radiating to the axillary region. No relevant surgical intervention 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=7289823
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« Reply #71 on: March 15, 2018, 02:08:37 AM »

Model Number 102
Event Date 04/12/2012
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization prior to distribution.

Event Description
It was reported through clinic notes received on 8/21/2012 and dated (b)(6) 2012, that the patient had been fighting recurrent left axillary abscesses and had recently been put back on medications. No additional information is known.

Manufacturer Narrative

Event Description
The device manufacturing records for the implanted generator were reviewed and sterilization, prior to distribution was confirmed.

Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2750888
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« Reply #72 on: March 19, 2018, 01:54:23 AM »

Model Number 102
Event Date 06/18/2012
Event Type Injury
Event Description
A registered nurse at the treating physician's office reported on (b)(6) 2012 to the company representative that the patient complained of left mid axillary pain and thought it was due to the vns having moved. A chest x-ray was ordered, and the nurse reported that it appears to have shifted slightly inferomedially. The electrode reportedly has moved as well. Previously, it was reported on (b)(6) 2012 from the surgeon's office that they were planning on seeing the patient for evaluation of the patient's reported complaint of pain at the generator site. The neurologist's office referred the patient to the ent to see if the complaint she had was related to another reason other than vns. An ent evaluated the patient and concluded that there may be generator migration which may be causing the discomfort at the generator site. Clinic notes dated (b)(6) 2012 reported that the patient still remains with difficulty tolerating the device. She has intermittent dysphonia, pain in the neck radiating to the ear and the mandible and sometimes problems swallowing. The previous visit they discussed referral to ent for evaluation, and the patient requested for the referral. The referral requested for evaluation of the neck, ear and mandible pain related to vns to see if there is a need to revise the area where the device is placed. On the previous visit on (b)(6) 2012, the patient presented with no side effects. Follow up with the referring neurologist revealed that the pain was first observed on (b)(6) 2010. The dysphonia and trouble swallowing are reportedly recurring problems noticed in (b)(6) 2010. The patient was advised to have x-rays taken and to be evaluated by a neurosurgeon. No patient manipulation or trauma occurred that is believed to have caused/contributed to the events, and no causal or contributory changes preceded the onset of the events either. The neurologist reported that the pain, trouble swallowing, and dysphonia are associated with stimulation. The patient does not have a pre-existing medical history of having difficulty swallowing prior to vns. Although surgery was still being considered in (b)(6) 2012, it had not been scheduled to date due to the physician wanting the patient undergo imaging studies. Attempts for additional information from the surgeon and treating physician's office have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received from the treating neurologist which revealed that medical/surgical intervention was planned with regards to the migration and discomfort at the generator site due to patient comfort and not to preclude a serious injury. The outcome of the repositioning surgery was "good", per the physician. The lead migrated due to "body habitus" (patient physique), however details were not provided. No causal or contributory programming or medication changes precede the onset of the lead migration. X-rays of the patient's vns were taken but have not been received by the manufacturer to date. The x-ray report was provided by the physician which indicated that the patient "complained of pain in the region of the vns device. Also states that she feels the device has shifted. Exam was done for vns placement. " chest x-ray of (b)(6) 2012 and also compared to soft tissues of the neck x-ray of (b)(6) 2010. The vns generator reportedly appeared to have shifted slightly inferomedically relative to its position previously. The electrode coursing into the base of the left neck appears intact; however, it also appeared to have shifted slightly, per the report. Previously, it was overlying the 2nd rib and on (b)(6) 2012 appeared to have shifted interomedially and was overlying the left apex. It coursed into the base of the neck as previously.

Manufacturer Narrative

Event Description
The patient had vns repositioning surgery on (b)(6) 2012. Further details were not available. Attempts for additional information have been unsuccessful to date. The clinic notes dated (b)(6) 2012, reported that the generator appeared to have shifted slightly inferomedially which was believed to have caused pain to the neck and left face area.

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« Reply #73 on: March 26, 2018, 12:53:46 AM »

Model Number 304-20
Device Problem Fluid leak
Event Date 08/26/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The patient reported that the surgeon informed her that the lead had fluid in it when it was explanted which he believed caused her pain.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all quality and functional testing prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by the patient's physician that the patient had been experiencing some adverse events associated with stimulation. The events started on (b)(6) 2012 and were described as a shocking pain, at the collar bone, which did not occur with every stimulation cycle. Additionally, the patient reported that she could see the lead pulsating during the stimulation. The patient was swollen all the way along the leads from the generator to the electrodes. The device was checked on (b)(6) 2012 and the diagnostics results were all normal and within normal limits. There was no reported trauma. It was reported that when the pulse width was lowered from 500usec to 250usec, the swelling went way within 15 minutes. X-rays were performed and the device was left enabled as the patient could tolerate the events and was doing well with vns therapy. Ap and lateral views of the neck and chest for patient were reviewed. The generator is seen in the left chest area. The filter feedthru wires appear intact and the lead pin can be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be behind the generator. The electrodes were observed in the neck and appear to be in proper alignment. The lead is seen routed down toward the generator. No lead breaks or fractures were observed. Based on the x-ray images provided, it appears that the generator and lead were implanted per labeling guidelines and no fractures or discontinuities are present. The cause of the reported issues could not be identified. Clinic notes were later received for this patient which indicated that the patient was also experiencing increased hoarseness with stimulation and protrusion of the lead. The swelling was said to noticeable and cause redness of the area. Additionally, the patient indicated that she was experiencing muscle spasms with stimulation as well. Following the decrease in settings, the muscle spasms and electrical shocks continued to a lesser degree and the patient also started experiencing an increase in seizures thought to be related to the lowered settings. On (b)(6) 2012, the pulse width was increased again to 500usec, and these settings were tolerated without issue for an hour. On (b)(6) 2012 the patient reported that she continued to have daily "shocking sensations" and "fluttering sensations" in the neck and near her armpit. These were said to be not severe. Additionally the patient reported that she is not performing any particular movements or actions when these feelings are occurring as it can happen when she is not moving and at rest. On (b)(6) 2012 the patient again reported daily electrical shocks with the shocking occurring 4 times on (b)(6) 2012. Additionally she reports neck swelling but indicated that she would not disable the device as therapy has been working for the patient. The patient was seen again on (b)(6) 2012. She reported that her shocking is dally and she can have up to 2 of the "shocking symptoms that startle her and make her jump" otherwise does feel the fluttering (feels electrical flutter) and pain with stimulation along the lead wires just under left collar bone. If she has those shocks, her neck swells and then it becomes red, then it goes into a chest pain/pressure. Diagnostics performed on that date were still within normal limits. While the patient indicated that there had been no manipulation or trauma, her husband indicated that there was pain in her chest caused by their dogs jumping on her. The patient was referred for revision and underwent a lead replacement procedure on (b)(6) 2012. It was reported by the patient's neurologist that, during the procedure, the surgeon identified small pin holes in the lead and bodily fluid inside the insulation. Attempts for product return have been unsuccessful to date as the hospital indicated that they do not have anything to return.

Event Description
Additional information was received on (b)(6) 2012 indicating that the revision surgery had resolved the pain issues. Additionally a review of the device manufacturing records indicated that the lead had passed all functional and electrical tests, as well as all quality inspections prior to distribution. A user facility report; number: (b)(4), was also received. This reported that the patient was experiencing "electric like shock above the stimulator and over the pectoral region". During revision, fluid was observed inside the lead insulation. The generator was tested during the procedure and was found to be functioning properly. No additional information has been made available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2824925
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« Reply #74 on: April 01, 2018, 01:41:19 AM »

Model Number 103
Event Date 03/02/2012
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of device history records confirmed that both the lead and generator were sterilized prior to distribution.
 
Event Description
On (b)(6) 2012, it was reported that this vns patient had an infection. The patient's device was explanted. On (b)(6) 2012, the patient underwent re-implant. The patient had autism and picked at the incision which caused infection. During revision, the generator was re-implanted far under the patient's armpit. It is unknown when the patient's device explanted prior to replacement. No additional information is available. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2855995
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« Reply #75 on: April 02, 2018, 01:06:22 AM »

Model Number 103
Event Date 01/13/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received that the patient¿s arm paralysis was approximately six years prior. The event had resolved, was no longer an issue, and was not believed to be related to vns.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 indicated that the patient suffered from seizures, headaches, and hemiparesis. Clinic notes dated (b)(6) 0213 indicated that the patient experienced increased back pain and that her hips were still sore because of injections. Clinic notes dated (b)(6) 2013 indicates that the patient had increased back pain with a possible event in her hips. The patient had to use her magnet over the last few days. Additional information was received indications that provided recent diagnostics results. The patient was referred for generator replacement. Surgery is likely but has not taken place.
 
Event Description
The generator analysis was completed on (b)(4) 2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
On (b)(6) 2013, it was reported that this vns patient was having breakthrough seizures and now feels tired all the time. The patient reported that the generator was put in arm pit, a pointy thing sticking out of the armpit that she had to get used to. The patient wasn't sure if the surgery caused nerve damage for she had a problem with her arm for 1 year post operatively and could not move her arm. Surgery is likely but has not taken place.
 
Event Description
On (b)(6) 2013, this vns patient underwent generator revision. The explanted generator was returned on (b)(4) 2013 and is pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3106886
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« Reply #76 on: April 14, 2018, 12:36:54 AM »

Model Number 303-20
Event Date 02/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a serious injury.
 
Event Description
Reporter indicated intermittent high lead impedance was noted for a patient who recently had vns generator replacement on (b)(6) 2013. The patient had no known trauma. The patient is also experiencing painful stimulation at the electrode site in the neck. X-rays were reviewed by the manufacturer. The electrodes are visualized at approximately t1 and are in alignment; the electrodes are implanted lower than what is usually seen. The generator is implanted in the left axilla. This is much more lateral than what is normally seen. The view does not allow full assessment of the lead pin insertion. The lead wire is intact at the lead pin. The filter feedthroughs are intact. There is a small amount of lead behind the generator that cannot be assessed. The cause of the high lead impedance is unknown at this time, but may be due to inadequate pin insertion or a lead fracture. Attempts for additional information are in progress.
 
Event Description
Reporter indicated the patient had vns lead pin reinsertion surgery performed on (b)(6) 2013. After the lead pin was reinserted into the generator header, diagnostics were within normal limits (3218 ohms). No new devices were implanted.
 
Event Description
Manufacturer review of the device history records for the vns lead and generator confirmed both devices passed all final testing prior to distribution.
 
Event Description
Additional x-rays were reviewed by the manufacturer. The lead pin did not appear to be fully inserted. No additional anomalies were noted. The surgeon indicated he felt the lead pin had been fully inserted as two audible clicks were heard when tightening the setscrew. However, the possibility of a lead fracture may also exist. Reporter indicated the patient was also having increased seizures and that the plan of care is to have vns revision surgery; however, this has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993250
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« Reply #77 on: April 17, 2018, 01:07:39 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Information was received that the patient was seen on (b)(6) 2013 for consult. The notes indicated that the patient¿s pain in the chest was not consistent with vns. It was stated that the (b)(6) event was a recurrent infection ((b)(6)), but it is unknown when this started as this information was provided by the patient. There was no documentation was available regarding the ¿heart problems¿; however, it was documented that the patient was negative for murmurs or gallops. No additional information or x-rays were available. Attempts for product return have been unsuccessful. An implant card indicated that the patient was explanted due to painful stimulation.
 
Event Description
On (b)(6) 2013, this patient underwent generator revision. The product has not been returned to date.
 
Event Description
On (b)(6) 2013, it was reported that this patient's device has shifted due to weight loss beginning in 2011. This was not causing the patient pain that began four days prior. For the past month, the patient had been observing a lump over the generator site, and since then, it has tripled in size. There was no manipulation/trauma and no medication changes or programming changes. The patient stated that she was last seen two months prior by her vns physician, and her device was found to be functioning properly. Additional information was received indicating that the a little over a month ago, a quarter-sized nodule was noticed near her generator. Now the area is swollen from the left side of her sternum to her arm pit, approximately the size of a hand. The outline of the generator is visible. The area is painful and bruising. There is no drainage or opening in the incision area, and there was no trauma to the area. Vns had controlled her seizures as she has gone from 15 per day to 2 to 3 per month. Clarification was given that the generator migrates from mid-left ribs to under the arm pit settings and diagnostics from (b)(6) 2013 were provided. The patient was referred for prophylactic replacement and pocket revision additional information was received that there may be a disc in the patient's neck that is out of place. (the left side of her neck had been swollen for several months, and she has limited movement on her left side. ) this is not related to vns. It was also suggested that the patient had heart problems, and the patient is a (b)(6) carrier. Surgery is likely but has not taken place.
 
Manufacturer Narrative
Event description, corrected data: previously submitted mdr inadvertently omitted information received during follow-up. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069093
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« Reply #78 on: April 18, 2018, 01:19:00 AM »

Model Number 103
Event Date 03/12/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient required a lead revision for an unknown reason. Follow-up showed that the surgery was for repositioning of the lead. During surgery on (b)(6) 2013, the patient's generator was in the axillary position and moved to chest area. It is unknown where in the chest the device was initially implanted. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative

Manufacturer Narrative
Corrected data: previously submitted mdr indicated the patient was the operator of the device. Additional information was received indicating that the physician may have contributed to the error. This report is being submitted to correct this data.
 
Event Description
Additional information was received indicting that the patient was referred for surgery due to pain/pinching in her axillary area. It is unknown exactly when this began. The surgery was for patient comfort. No patient manipulation or trauma occurred that is believed to have caused/contributed to the event. A non-absorbable suture was not used to secure the generator to fascia during implantation of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3043572
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« Reply #79 on: April 22, 2018, 12:47:57 AM »

Model Number 102
Event Date 04/15/2013
Event Type  Malfunction   
Event Description
The surgeon reported that a non-absorbable suture used to secure the generator to fascia during implantation of the device on (b)(6) 2012.
 
Manufacturer Narrative
Review of manufacturing records performed. Review of the generator manufacturing records confirmed all quality tests were passed prior to distribution.
 
Event Description
It was initially reported that the patient reported to the neurologist that her generator migrated to the left axillary area. The neurologist¿s office reported on (b)(6) 2013 that they were referring the patient back to the implanting surgeon as they suspect that the lead has come disconnected from the generator, and the patient was having an increase in seizures since the early part of the prior week. Additionally, the neurologist¿s office was unable to interrogate the generator on (b)(6) 2013. It was unknown by the nurse at the neurologist¿s office if patient manipulation or trauma occur that is believed to have caused/contributed to the generator migration. The patient later reported on (b)(6) 2013 that she is considering having her device removed. She reported that three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking; these events are captured in mfg report number: 1644487-2013-01474. She also reported experiencing hot flashes. She reported that her seizures have reduced from daily to 5 times in the last year. The last vns dosing adjustment was (b)(6) 2013, in which she reported that the neurologist turned the vns settings up. However, this has not been confirmed by the neurologist to date. Attempts for information from the neurologist have been unsuccessful. Additionally, attempts to the surgeon regarding type of suture used to secure the generator to the fascia during implant surgery have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3123691
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« Reply #80 on: April 29, 2018, 01:49:26 AM »

Model Number 103
Event Date 05/23/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 information was received that the physician had had a visit with the patient that morning for follow-up after a recent generator replacement surgery. The physician noted that the patient¿s generator site was exposed by approximately 1 cm, that the generator was visible, but that there appeared to be no signs of infection. The patient¿s mother stated that the patient had been picking at the incision site. The physician stated that the site appeared to be healing and that he would see the patient after another week to monitor the healing process. If the site is not healed by then, the surgeon was considering removing the generator and placing it in another site. The physician did not prescribe any antibiotics during the visit because the site did not appear to be infected. A review of manufacturing records confirmed that both the generator and lead passed all functional tests prior to distribution, as well were properly sterilized prior to distribution. Follow-up with the physician indicated that at the follow-up visit he had observed that the implant, which had been implanted into the axillary incision from prior implant, was visible through the sutures. The physician stated that at the (b)(6) 2013 visit there had been erythema around the generator site and that at the follow-up visit the erythema had decreased considerably so and that the site was beginning to look better and beginning to granulate slowly. The physician stated that if the site does not granulate completely that he would have no choice but to explant the generator and either let the incision heal completely before reimplanting again in that location or placing the generator elsewhere instead. The physician will continue to monitor the situation. Attempts for additional information are still in continuation.
 
Event Description
A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 072 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 2. 826% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a small portion of the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Dried body fluids inside the outer and inner tubing was observed in some areas. Continuity checks of the returned lead portion 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 portion of the device. Note that since a small portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other information has been provided.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead and that they passed all functional tests prior to distribution.
 
Event Description
Additional information was received stating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.
 
Event Description
On (b)(4) 2013 information was received by the reporter that the patient had been tentatively scheduled for a vns revision surgery on (b)(6) 2013 due to the generator being exposed at the chest incision site. Follow-up determined that the patient instead underwent surgery on (b)(6) 2013. The patient had completely removed the generator from his chest and approximately 5 cm of the lead wire was also exposed. The generator and lead were both explanted by the physician and the physician intends to wait a month to allow the incision sites to fully heal before reimplanting vns in the patient. It was also reported that the patient had a skin condition and will be referred to a dermatologist for diagnosis. The explanted lead and generator have been returned to the manufacturer and will soon undergo product analysis. Attempts for additional information will remain in continuation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3165711
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« Reply #81 on: May 08, 2018, 02:21:16 AM »

Model Number 102
Event Date 06/10/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent explant after experiencing a severe wound infection. It was reported that the patient was seen at a hospital and was given antibiotics. Then approximately a month and a half later, the patient was seen by the physician to have the device explanted. It was reported that cultures were negative, but that they were most likely negative due to the antibiotics the patient took. The physician indicated that the patient may have induced the infection by "scrubbing" the infection and because of his low socio-economic status. Further follow-up revealed that the patient experienced a focal axillar dehiscence three weeks post op which had reported healed after a few days. It was reported that two months post op the patient experienced major wound dehiscence with purulent discharge. Attempts to have the device returned for analysis have been unsuccessful to date. It was reported that the hospital is refusing to release the device.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3355839
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« Reply #82 on: May 11, 2018, 01:10:50 AM »

Model Number 102
Event Date 10/04/2013
Event Type  Injury   
Event Description
Further follow-up revealed that the patient's surgery occurred as planned on (b)(6) 2013. Only the generator was explanted. It was reported that the surgery was for patient comfort. It was reported that the patient was not using vns therapy as prescribed because the patient wasn't being followed by a psychiatrist and having the device programmed as needed. No known causal or contributory factors preceded the onset of the events. It is unknown if a non-absorbable suture was used to secure the generator to the fascia during the implant surgery. Attempts to have the generator returned for analysis have been unsuccessful to date.
 
Event Description
Initially, it was reported that the patient has been experiencing difficulty swallowing and shortness of breath. The patient reported that this is more often than not. The patient also reported that it feels like the device is shocking her from the generator to up under her tongue. The patient reported that taping the magnet over the generator was attempting, but was too painful. The patient also reported that the generator feels like it is slipping down into her armpit. The patient reported that the device has not been checked in three to four years. The patient was later seen by a surgeon and surgery was scheduled. It is unknown whether or not surgery occurred as planned. Attempt to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3472747
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« Reply #83 on: June 10, 2018, 12:35:41 AM »

Model Number 106
Device Problem No Known Device Problem
Event Type  Injury   
Event Description
It was reported that the patient was experiencing generator migration in the breast and armpit areas, protrusion, and pain to the point where it was noticeable. The generator was believed to have either never been secured, or the stitch had broken. The generator was also larger than her previous model. No surgical intervention to correct the migration/protrusion has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7517351
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« Reply #84 on: July 06, 2018, 08:36:28 AM »

Model Number 304-20
Device Problem Mechanical issue
Event Date 06/26/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for a full revision. It was reported that since the time of the patient¿s battery replacement in (b)(6) 2017, the patient has complained of intermittent shocking pain that travels from his armpit area up to his lateral left neck and only occurs when the vns is on. The device was turned off and the events stopped. X-rays were stated to show nothing. The patient underwent a full replacement. The surgeon state that the lead insulation near the generator was no longer present, causing the wires to be exposed. This was the area the patient was feeling the shocking sensations. System diagnostics were performed before surgery and impedance was ok. The generator was on prior to the surgery staring. It was stated he was on rapid cycling according to the surgeon¿s notes. However it was stated he was in patient for an emu stay at some point in the last 24 hours and his settings were changed. The explanted generator and lead were received for analysis. Analysis is underway but has not been completed 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=7650646
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« Reply #85 on: August 10, 2018, 03:41:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/04/2018
Event Type  Injury   
Event Description
It was reported that surgery was being taken to reposition the patient's generator as the generator had migrated to an axillary position. It was also reported that the generator had been replaced recently and since there had been issues with wound healing and the wound had opened. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726467
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« Reply #86 on: August 25, 2018, 06:02:20 AM »

Model Number 100
Event Date 04/21/2011
Event Type  Injury   
Event Description
It was reported to the manufacture from explanting physician in (b)(6) that he had a patient with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular. In the last 2 years, the patient had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 years due to battery exhaustion. The patient insisted on having their vns system explanted related to their pain events. It is unknown if this surgery was for patient comfort or to preclude a serious injury to the patient. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted here as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Their explanted generator was returned for analysis. In the product analysis laboratory, it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specification. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133608
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« Reply #87 on: September 21, 2018, 01:28:49 PM »

Model Number 102
Event Date 03/01/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient may have experienced some sort of an axillary infection in (b)(6) 2014 from poking and scratching at his device. The patient¿s device was reported to be functioning well at the time. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 reported that the patient had been treated for an ¿abscess¿ in the left axillae with an incision and drainage by his primary care physician on two occasions recently. The most recent was about a week and a half prior. The patient denied any antibiotic prescription given. The patient reported that it had returned somewhat. Upon physical examination, there was an approximate 1. 5 inch length palpable lesion in the left axillae which was soft but not mobile. There was no redness or skin breakdown. There was no tenderness to palpitation. The physician¿s assessment at that time was that the lesion may represent a sterile cyst versus infection abscess with the infection abscess less likely. Clinic notes dated (b)(6) 2014 reported that the patient had an axillary cyst which had since been drained and appeared to have improved at that point.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the generator device history records confirmed sterilization was performed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3882083
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« Reply #88 on: October 06, 2018, 04:58:23 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns had migrated from the chest to the underarm and was causing pain. The patient expressed her desire to have the device removed. It was later reported that the patient was referred for generator replacement surgery. Device diagnostics were reported to be normal. No relevant surgical intervention is known to have 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=7878253
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« Reply #89 on: October 10, 2018, 02:44:52 AM »

Model Number 302-20
Event Date 04/05/2012
Event Type  Malfunction   
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".
 
Event Description
It was reported that the patient's vns was now indicating high impedance with dcdc=7 during a system diagnostic test. The patient has not had any adverse events however the physician indicated that she believes the generator has been migrating towards the patient's armpit. The physician indicated that this migration could have contributed to the high impedance. X-rays were taken that reportedly did not indicate any issues however they will not be sent to the manufacturer for review. No trauma or manipulation is believed to have occurred. Last known diagnostics were taken on (b)(6) 2010. Attempts for additional information have been unsuccessful to date.
 
Event Description
Surgery to replace the patient's lead and generator has occurred. Diagnostic results following lead and generator replacement were normal following replacement. It was noted that a non-absorbable suture had been previously used to secure the generator. Attempts for the return of the explanted lead and generator were unsuccessful as the implant hospital indicated they believe the explants had been discarded after surgery.
 
Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2560371
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« Reply #90 on: November 10, 2018, 03:41:00 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/27/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient's generator has moved laterally almost into the axilla and is causing itching and pain. Information was obtained from the implanting physician that absorbable sutures, 2. 0 prolene, were used during the implant procedure. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7994752
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« Reply #91 on: November 10, 2018, 03:41:39 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
Event Type  Injury   
Event Description
Information was received that the patient generator had moved into the left axilia. Additional information was received from the surgeon's office that absorbable sutures were used. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7984832
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« Reply #92 on: December 07, 2018, 09:24:04 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/16/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to the vns generator.

Event Description
It was reported by the patient that their generator had migrated into her armpit. The patient was experiencing adverse events related to the generator migration such as pain around her collarbone and ribs. The patient also reported that she had lost a bit of weight. The patient was referred for surgery. 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=8095773
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« Reply #93 on: December 10, 2018, 03:19:16 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Injury  
Event Description
It was reported that the patient was referred for vns explantation surgery due to irritation along the chest and left axilla, which the patient attributed to the vns. The vns was previously disabled for reasons unrelated to the vns. 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=8091038
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« Reply #94 on: December 14, 2018, 06:43:49 AM »

Model Number 105
Event Date 08/12/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).

Event Description
It was reported by the physician's office that the patient was admitted to the hospital due to infection. The patient was going to be replaced; however, the site did not have a replacement generator and needed a company representative to provide one for the replacement. A company representative later confirmed he attended the replacement surgery on (b)(6) 2016. He confirmed the patient's generator was replaced due to infection and the new generator remained programmed off. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The explanted generator was received by the manufacturer for analysis. Product analysis is expected, but has not been completed to date.

Event Description
Product analysis (pa) for the returned generator was completed. While the reported infection is beyond the scope of the activities performed within the pa lab, the potential contributing factors have been considered and evaluated and none were found to exist in the reported situation. The diagnostics for the generator were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

Event Description
It was later reported by the physician that the infection was first observed within the clinic on (b)(6) 2016. Due to this information, additional follow up was performed at which point it was explained that the patient had a subsequent infection and that the original infection was first observed on (b)(6) 2016. It was noted the family had called the physician's office on (b)(6) 2016 with a report of swelling, the patient went to the ed (emergency department) on (b)(6) 2016, and the generator device was replaced on (b)(6) 2016. During the replacement surgery on (b)(6) 2016, the chest wall was washed out and the patient was placed on a normal regimen of iv antibiotics. It was noted the believed cause of the infection was due to the placement of the device in the axillary region, as opposed to the chest, and the patient is in a wheelchair. It is felt that the sweat is a contributing factor in the wound getting infected. The information regarding the second infection has been reported in mfr. Report 1644487-2016-02467.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5942349
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« Reply #95 on: December 16, 2018, 04:03:36 AM »

Event Date 03/25/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the vns patient was complaining of pain in both incision sites that had started on (b)(6) 2013, but is working with her pain management doctor to get relief. The patient's vns had not yet been turned on. On (b)(6) 2013, the patient reported that on (b)(6) 2013, she noticed a small amount of "green cloudy" drainage from the "top" portion of her generator incision, left axilla. On (b)(6) 2013. The very top of the same incision "opened up", approximately 2mm, and there was no further drainage. The patient went to the emergency room and didn't tell them about the prior day's drainage and they just cleaned the incision and placed a gauze dressing over the incision. The patient stated that in the last week she has run a fever up to 101 twice, has taken ibuprofen and has had no fever for the last few days. The patient stated that the left axillary incision is red, swollen, and tender to the touch; pain scale of 7-8. The patient stated that she showered about the 4th day post-operation. The physician reported that the patient needs to go to the emergency room immediately because the vns could be infected and therefore, might have to be removed or revised. The physician later reported that the event was due to the patient's surgery and the only intervention planned was pain medications. The patient's generator was turned on. The surgeon is working with a local physician where the patient lives to follow-up on the patient's infection. Good faith attempts for the patient's implanted product information were made to the implanting hospital but the information has not been received to date.

Manufacturer Narrative

Event Description
Additional information received on (b)(4) 2013 when it was reported that the patient was doing much better and the incision site is healing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3074526
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« Reply #96 on: December 19, 2018, 12:33:58 PM »

Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported from the physician that the patient was seen on (b)(6) 2015 and the patient states she believed the device had migrated but she saw the surgeon and no surgery is needed as of (b)(6) 2015. No surgery or interventions that are known have occurred to date.

Event Description
It was reported by the patient that the generator had migrated towards her arm pit leading to the wrapping of the lead around her thyroid thus causing damage to her left vocal cord for which surgery would have to take place, specifically, removal of the left vocal cord. Attempts for further information from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4680987
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« Reply #97 on: December 22, 2018, 10:13:32 AM »

Model Number 103
Event Date 06/19/2013
Event Type  Injury   
Event Description
The patient's vns device was removed due to infection at the site. The infection was first observed on (b)(6) 2013. A wound swab from the left neck wound indicated staphylococcus aureus. This was treated with antibiotics. On (b)(6) 2013, there was revision and cleaning of the left axilla wound. Inflammatory exudate seen, but no pus observed. Treated with antibiotics. (b)(6) 2013 - inflammation of the left axilla wound. A wound swab showed staphylococcus aureus. The vns generator and lead were removed on (b)(6) 2013. Cloudy fluid was seen, but there was no obvious pus. Heavy growth of staphylococcus aureus seen and treated with antibiotics. The medical professional stated that the relationship of the infection to vns was likely an external cause. No patient manipulation or trauma was noted. The anatomical location of the infection was not thought to be a factor. Cultures confirmed staphylococcus aureus. No other information was provided.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3538529
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« Reply #98 on: January 04, 2019, 09:28:34 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. 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=8190458
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« Reply #99 on: January 04, 2019, 09:29:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing pain at the generator site, which was at the left armpit due to a chest tattoo. The device was causing discomfort due to being much larger (m106) than the patient¿s previous m103. The patient has a follow-up appointment with the surgeon to discuss moving the vns generator. 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=8181673
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« Reply #100 on: January 15, 2019, 02:56:13 AM »

Model Number 102
Event Date 04/10/2014
Event Type  Injury   
Event Description
It was reported that the patient's generator is more towards his axilla than before and there has been some questioning if this is due to the patient's activity at the gym along with fighting with his brother. No surgical intervention has been performed to date.
 
Manufacturer Narrative

Event Description
The patient underwent surgery at which time it was noted that there was no evidence that the generator had migrated. It was noted that the implanting surgeon inserted the generator through the axilla.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3809026
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« Reply #101 on: January 20, 2019, 03:12:08 AM »

Model Number 103
Event Date 04/22/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.
 
Event Description
It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.
 
Event Description
It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.
 
Event Description
Additional information was received that the patient's generator could never get regulated correctly. It is suspected that the regulation of the device refers to titration. Available programming history for the generator was reviewed. The patient's device was disabled the day of explant. Diagnostics at that time were within normal limits. After implant of the device, it was titrated to 0. 25 ma and the output current was increased up to 1. 5 ma a few months later. However, the settings were reduced down and disabled shortly after.
 
Manufacturer Narrative
Only the generator was replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253
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« Reply #102 on: February 07, 2019, 02:23:37 AM »

Model Number 300-20
Event Date 11/10/2014
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2015. The explanted devices were discarded after surgery. Therefore, analysis is unable to be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance (10,000 ohms). There was no trauma or manipulation that occurred that is believed to have caused or contributed to the high impedance. The device was programmed off and the patient was referred for surgery. Further follow-up revealed that the patient had undergone generator replacement on (b)(6) 2014. It was reported that device diagnostics on (b)(6) 2014 were within normal limits (3554 ohms). The patient was seen again on (b)(6) 2014 and device diagnostics were again within normal limits (3621 ohms). The physician assistant indicated that the generator was located in the axilla region and there was a possibility that the placement of the generator has caused the lead pin to become dislodged or the flexion of the patient's arm may have caused a fracture. X-rays were taken and it was reported that no lead discontinuity was identified. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4316945
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« Reply #103 on: February 07, 2019, 02:24:19 AM »

Model Number 104
Event Date 02/25/2014
Event Type  Injury   
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported this data incorrectly.
 
Event Description
Initially, it was reported that the patient was experiencing a shocking sensation with device stimulation following generator replacement. It was reported that device diagnostics were within normal limits. The physician indicated that the patient may be referred for lead replacement. It was later reported that the patient was referred for generator and lead replacement at the patient's request. No additional relevant information has been received to date. Surgery is planned, but has not occurred to date.
 
Event Description
The patent had generator pocket revision on (b)(6) 2015. The surgeon moved the generator from the armpit area and into the front chest area below the collarbone. While moving locations, he decided to replace the generator in the process due to the patient's complaint of shocking sensations. The explanted generator was discarded. Therefore, analysis is unable to be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4441302
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« Reply #104 on: March 14, 2019, 06:10:56 AM »

Model Number 304-20
Event Date 12/01/2014
Event Type  Injury   
Event Description
It was reported on (b)(6)2015 that the patient¿s incision is starting to open and the patient¿s mother thinks she can see the lead wires. The patient¿s most recent vns surgery was a full revision on (b)(6) 2014 (captured in file (b)(4)). The mother first noticed it appeared ¿bubbly¿ on (b)(6) 2015 and the physician put the patient on antibiotics. Things then seemed better. However, the morning of (b)(6) 2015 the patient¿s crusty scab fell off and now the patient¿s mother thinks she can see the lead. The patient¿s physician noted that the extrusion was located at the left axilla. He noted that the patient¿s previous re-implants of generators through the initial axillary led to the battery migration laterally to incision twice (b)(6) 2014 and (b)(6) 2015. The physician indicated that the patient has generalized seizures where the patient strikes her chest and has a tendency to pick at the incision line. The first dehiscence was in (b)(6) 2014 and was treated with antibiotics and the generator was placed deeper with layered closure to prevent migration. No causal or contributory medication or diet changes (affecting wound healing) preceded the onset of the extrusion. There was no infection, just exposure to surface bacteria. Cultures showed results of skin flora, ¿staph epi¿.
 
Event Description
Additional information was received that the patient's lead wires were coming out of the patient's arm pit incision site. The generator is in place but the excess lead has migrated to the arm pit and is extruding from the old incision site. Patient underwent surgery to reposition the lead wires on (b)(6) 2016. Patient manipulation is not suspected to be the cause. According to the surgeon, patient's vns device was originally implanted under the pectoral muscles and generator was in the armpit. In (b)(6) 2015, the leads had extruded out of the skin and the surgeon had gone in and moved the generator to a new location in the chest. He did not move the leads due to risk of damaging it and just routed the leads to the generator in the new location. However now, some of the leads is again extruding out of the skin in the old generator location. He suspects that the contractions of the pectoral muscles are what caused the leads to be pushed and extruded out for both times. The surgeon went back into the area of the extrusion and pushed the leads in further and cleaned out the area. Device was not even taken out of the body and no replacement of products took place. No visible infection was seen. Diagnostics performed afterwards showed everything was ok with 2611 ohms and ifi=no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5159327
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« Reply #105 on: March 16, 2019, 02:00:03 AM »

Device Problems Generator; High impedance
Event Date 07/01/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device had returned high impedance upon diagnostics in (b)(6) 2015. The patient¿s generator was implanted in the axilla. The patient had been implanted in (b)(6) 2014 with a generator model 102. It was reported that the vns therapy had yielded benefit for the patient. In (b)(6) 2015 system and normal mode diagnostics were run and they returned impedance within normal ranges, with dcdc2 and dcdc3 respectively. Diagnostics performed early in (b)(6) 2015 returned high impedance. The patient underwent a generator replacement in mid (b)(6) 2015 with a generator model 103. No x-rays were taken. Diagnostics were run in (b)(6) 2015 on the generator model 103 and they returned high impedance with 9000 ohms. The patient¿s settings at the time were programmed at 2ma, 30sec on-time, 5 min off-time. Diagnostics were run on (b)(6) 2015 which returned high impedance 5000 ohms. The patient¿s generator was not switched off upon parents request as it is believed that the patient is still having benefit from vns. A lead surgical revision is expected but it has not been confirmed to date.
 
Event Description
Further information received indicates that the device was disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5133935
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« Reply #106 on: April 06, 2019, 01:41:30 AM »

Model Number 106
Device Problem Corroded
Event Date 02/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator explant due to their generator "eroding" at the site where the lead enters the generator, the header receptacle. The physician indicated that were was evidence of infection in the cervical and chest pockets and that the patient had wound dehiscence through his vns site. The patient was admitted to the hospital and given antibiotics. The patient's vns was removed, cultures were taken, and the infection was reported to have been cleaned out. It was reported that the vns site was "glued and looks great" and that the epileptologist requested to have the vns replacement placed in the patient's left axillae or left back. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications and was sterilized prior to distribution. The explanted suspect product has not been received to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387619
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« Reply #107 on: April 07, 2019, 02:42:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that this patient has a wound infection of the left axilla. Additional information was received that the patient first presented with the infection with an aching in their left axilla. The majority of the infection was located at the wound site, but the physician thinks the infection expanded to the generator area, but the wound site was not open. It was stated that this patient has diabetes with poor glycemic control, and therefore is at increased susceptibility to infection. Therefore the physician thinks the bacteria might be penetrated from the wound site at the left axilla and expanded to the generator area. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No known surgical intervention has occurred to date. No further relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424229
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« Reply #108 on: April 09, 2019, 12:48:28 AM »

Model Number 300-20
Event Date 12/01/2012
Event Type  Malfunction   
Event Description
It was reported that the patient's vns lead had experienced a fracture. It was not made apparent how the initial reporter determined there was a fracture problem. The device was reportedly disabled in (b)(6) 2012 in relation to this issue. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
It was reported that the patient's explanted generator was discarded following surgery. No additional pertinent information has been received to date.
 
Event Description
Follow up attempts with the treating physician showed that although a lead break was suspected, it was never confirmed. X-ray images according to the treating physician showed no visible fracture. The vns was reported to have been "interrogated" few times with no abnormal results. The patient complained of pain at the time of the device disablement. The pain was occurring in the area of the left axilla and radiated into the upper left chest and neck, and did not coincide with stimulation. The patient's generator was explanted on (b)(6) 2016. The device has not been returned to the manufacturer to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5697512
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« Reply #109 on: April 15, 2019, 01:29:46 AM »

Model Number 103
Event Date 04/22/2016
Event Type  Injury   
Event Description
On (b)(6) 2016, patient mentioned that she thinks the generator is drifting more laterally on her chest wall. X-rays were taken and was reported to be intact per the physician. Further attempts to learn whether non-absorbable suture was used to secure the generator in place on (b)(6) 2012 were made but were unsuccessful to date. Clinic notes were received for patient's referral for prophylactic generator replacement with the intention of addressing the generator migration at that time. Clinic notes stated that the patient's generator is dislodged from the pocket and is projecting through the skin in the armpit. The patient was referred for surgery to reseat the generator in the pocket. The device was checked and was confirmed to be working fine. The settings were increased as patient feels that she is experiencing breakthrough auras and seizures. Patient underwent prophylactic generator replacement on (b)(6) 2016. The explanted generator will not be returned to manufacturer by the hospital. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the patient did experience an increase in seizures and auras but its below pre-vns baseline and is not believed to be related to vns. This will not be captured/coded as a result. The physician is uncertain on the cause of device migration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5853731
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dennis100
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« Reply #110 on: April 29, 2019, 05:56:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had tachycardia and premature ventricular contraction with stimulation that was detected upon a surgical consultation for pain. Initially, the patient reported that she was having a severe burning in her chest, which she associated with her generator being turned on to 0. 625 ma after having a generator replacement surgery for battery depletion. It was later reported by the surgeon that the patient went to the emergency room on (b)(6) 2016 with severe pain at one point on her axilla incision and around her generator. The surgeon believed that the pain was related to a "loose connection" and the patient was referred for a full revision surgery. Her device was also turned off. However, during the surgery consultation, the patient decided to post-pone the surgery indefinitely. When the patient was turned back on to 0. 125 ma, the patient felt severe pain. Her pain was described as a sharp shooting pain around the generator pocket and the incision site which started within 30 seconds of turning the generator on. At this appointment, the surgeon noted that the patient was also having tachycardia during stimulation which resolved along with the pain after the device was turned back off. The relationship between the painful stimulation and the tachycardia is unknown. At a follow-up appointment with a neurologist, the patient was turned back on again and it was noted that the patient had runs of ventricular tachycardia and premature ventricular contractions along with pain when the vns was on but that it self-resolved. The device was turned back off due to the pain. It was noted that the patient had congestive heart failure which is captured in mfg report # 1644487-2016-02900. No additional relevant information has been received to date. No known related surgical intervention has occurred to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: the initial report inadvertently reported (b)(6) 2016 as the date received instead of (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6227316
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dennis100
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« Reply #111 on: May 03, 2019, 02:01:07 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434722
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dennis100
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« Reply #112 on: May 07, 2019, 07:19:17 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient's generator had migrated and the edge was pushing against the skin causing a breakdown of tissue. Clinic notes were received showing the patient was referred for an urgent evaluation of an extruding generator. It was also noted the patient had been experiencing some discomfort at the generator site and that the generator had seemed to migrate towards the axilla and recently developed a bluish discoloration with thinning of the skin, but without discharge. The patient denied fever, chills, or any change in status and the generator was still functional. Subcutaneous fluid collection and swelling were also noted at the generator site. The patient was referred for explant of the generator and the lead. It was later reported by the physician that the patient did not have an infection as the culture had come back as negative.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr. Report. If explanted, give date; corrected data: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
The patient underwent vns explant on (b)(6) 2017. The physician did not know the cause of the migration.
 
Event Description
It was reported that the patient was experiencing an increase in seizures that began prior to the explantation of the vns. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6398375
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dennis100
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« Reply #113 on: May 18, 2019, 12:59:20 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/09/2015
Event Type  Injury   
Event Description
It was reported by the patient that her generator was visible beneath her skin and that she was experiencing pain at her generator site because the skin over the generator was so thin. The patient mentioned that her device had been like this for two years. The patient's generator later migrated to her armpit and was causing her pain. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently listed aware date as 03/09/2017 instead of 03/10/2017.
 
Event Description
The nurse reported that the physician did not have an opinion about the protrusion or migration given the anatomical location the device had migrated to. The patient did not experience any trauma to the site that could have contributed to the generator protrusion and migration. The nurse mentioned that the protrusion was noticeable to the patient, but the patient never manipulated the generator. As such, the physician believed that the generator must have fallen down on its own. The physician planned to resolve the protrusion and migration during replacement surgery. The nurse indicated that the surgery was not required to preclude a serious injury and was for patient comfort. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient underwent full revision surgery. The new generator was implanted in a different position to resolve the migration and protrusion that occurred with the now-explanted generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6452971
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dennis100
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« Reply #114 on: May 27, 2019, 11:17:35 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient was complaining of pain around the vns in the chest and left shoulder. The pain occurred when the left chest area was touched. The patient was referred to a surgeon for further evaluation, including a ct of the left chest, an emg, and x-rays of the ribs without a possible cause for pain shown. There was no infection or any problems seen in the left chest. The patient was subsequently referred for explant surgery with relation to the tenderness over the left armpit and vns chest site. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
Further information was received from both the patient¿s treating neurologist and surgeon that showed the surgery was not to preclude a serious injury. The patient¿s generator was subsequently explanted in surgery. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6653715
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