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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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