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dennis100
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« on: August 15, 2018, 03:28:21 AM »

Model Number 105
Event Date 10/27/2014
Event Type  Injury   
Event Description
The surgeon reported that the patient¿s vagus nerve has been damaged after explant surgery. The patient was having difficulty swallowing after explant and was kept overnight as a result. The patient was put on a thickened diet with no regular liquids. Upon follow-up, the surgeon reported that the patient needed debridement and a skin flap for his wound. The patient had an allergic reaction to the device which contributed to the vagus nerve damage. It was reported on (b)(6) 2015 that the patient has had a good outcome from the thickened diet.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not include the vagus nerve damage. Upon further follow-up, the physician indicated that it was believed the event was related to the events reported on the initial report.
 
Event Description
It was reported that approximately two weeks after implant surgery ((b)(6) 2014), the neurologist turned on the patient¿s device to 0. 25ma. During this time, the incision site became reddened. The patient¿s caregiver applied 40% zinc oxide which decreased the redness. When he saw the surgeon for follow up, the surgeon indicated that the incision had healed well. With continued increase in settings at following dosing appointment(s), it was reported that the area of the generator has become red and inflamed again in spite of the 40% zinc oxide. The neurologist advised that the patient see the surgeon. The caregiver felt like the patient¿s body may have been rejecting the device. She thought that she could see the metal of the generator through the skin. It was felt that the patient may have been picking at his device and that the mother reportedly removed the dressing earlier than advised. Hygiene may have also have been a contributing factor. The surgeon reported that the patient¿s skin over the generator has ¿basically sloughed off. ¿ the patient was scheduled for explant surgery due to infection. Device diagnostics were reportedly within normal limits. Explant of the generator and portion of the lead occurred on (b)(6) 2015. At that time, the surgeon stated he felt that the issue was an allergic reaction more so than an infection. The patient saw plastic surgery on (b)(6) 2015 for the wound, they feel that they can suture rather than skin graft the chest.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the manufacturer device history records confirmed sterilization was performed for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4444478
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dennis100
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« Reply #1 on: August 15, 2018, 03:28:52 AM »

Model Number 302-20
Event Date 01/29/2009
Event Type  Injury   
Event Description
It was reported that the vns pt experienced swelling, wound dehiscence and allergic reaction at the electrode site. The pt was reportedly hospitalized and the events were resolved surgically. Diagnostics tests revealed proper device function. It was indicated that there was no pt manipulation that led to the events. It was also indicated that the pt did not have a medical history of allergies prior to vns. The events were determined to be due to wound dehiscence and definitely related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1356631
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dennis100
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« Reply #2 on: August 15, 2018, 03:29:20 AM »

Model Number 101
Event Date 11/09/2010
Event Type  Injury   
Event Description
A physician reported that a vns patient had the vns system removed due to "discoloration and itching along the skin line directly over the generator. " the patient was now currently seeing a dermatologist, but she still had the same issue continuing. Follow-up was obtained and it was indicated that the patient's neurologist and current dermatologist felt the symptoms were related to the implant of the vns and a reaction to its metal. Furthermore, the dermatologist stated the itching and discoloration was only around the generator site and that an allergic reaction of this sort could come about at any time. The dermatologist now stated she believed it may be a reaction to the generator's epoxy header. Additional attempts for further information have been unsuccessful to date, and the explanted material has been discarded by the explanting facility. However, last known diagnostics show proper device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2069298
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dennis100
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« Reply #3 on: August 15, 2018, 03:29:53 AM »

Model Number 302-20
Event Date 03/18/2009
Event Type  Injury   
Manufacturer Narrative
Patient physiology caused or contributed to the event.
 
Event Description
It was reported that the electrodes of a vns patient's lead had begun to extrude through the skin of her right neck. Follow up with the patient's explanting surgeon revealed that the event was believed to be related to the patient being allergic to the material on the electrode. Though the patient has undergone several lead replacement surgeries due to patient manipulation, the patient's surgeon and treating vns therapy physician indicated that there had been no admissions of manipulation for this recent event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1397148
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dennis100
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« Reply #4 on: August 15, 2018, 03:30:28 AM »

Model Number 103
Event Date 04/01/2013
Event Type  Injury   
Event Description
No interventions have been taken or planned.
 
Event Description
Additional information was received regarding the patient. The patient continued to have problems with the wound due to discharge. The discharge was repeatedly cultured and was sterile. This issue was felt to be due to the patient¿s body rejecting the device and attempts were wanted to prevent explanted so the patient could get therapy. Topical conservative treatment and repeated debridement and suturing of the wound were ineffective. The patient was treated with a (b)(6) bath which also did not help. The vns system was explanted and the reported wound issues were related to surgery. Pictures were provided to the manufacturer showing the extrusion of the lead and electrodes and there was no pus in the wounds. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
The generator analysis was completed on (b)(4) 2013. Results of diagnostic testing indicated the device was operated 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. The lead analysis was completed on (b)(4) 2013. During the visual analysis the connector boot and inner silicone tubes appeared to have been cut / torn. This most likely occurred due to manipulation of the lead during the explant procedure. The slice mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portions 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. 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.
 
Event Description
On (b)(6) 2013, images of a post-operative vns implant site were provided with a possible allergic reaction. The incision sites appear red with several red, raised bumps. There were white rectangles with sutures on them noted at the incision sites: 4 at the chest incision site and 8 at the neck incision site. The patient¿s skin appears to have hives. The event began before (b)(6) 2013, and the patient returned to the physician with the same problem. The event was believed to be related to surgery. It was later stated that the patient was in full recovery/convalescence from those wounds. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
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=3119292
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dennis100
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« Reply #5 on: August 15, 2018, 03:31:09 AM »

Model Number 304-20
Event Date 12/18/2014
Event Type  Injury   
Event Description
On (b)(6) 2016 an email was received that the patient developed a cellulitis that needs to be removed. Additional information was received that the patient had her battery and lead wires removed on (b)(6) 2016 due to an infection. Patient is not sure if the coils are still intact on the vagus nerve as one of the coils came through the small open wound on patient's neck incision that never healed after she was implanted on (b)(6) 2014. Patient could not remember the month or year this happened. The opening was big enough to insert tip of qtip. Patient stated that the open wound happened approximately about a month after sutures were removed by the surgeon. Patient was instructed to use neosporin on the open wound, keep it dry and let air get to it. No oral antibiotics were given. Patient did not go to primary care provider at this time either. When one of the tie-downs was pushed through the wound opening in patient's neck, patient consulted the surgeon, who discussed that it was patient's body rejecting the device and that patient should be ok since there were two other tie downs in place. In 2015, patient had a mammogram. Patient thinks that the compression from the mammogram machine pulled the wires and made the generator move. Patient had to have surgery on the leads after that because the leads were displaced. Patient underwent repositioning surgery on (b)(6) 2015 for patient comfort. After the leads were repositioned and tied down, patient stated she was ok but still had the small wound on her neck and that it would open and close up on its own and at times leak some fluid. Patient was referred to wound care center for treatment for a couple of months. Patient later got a very bad sore throat, ear ache and was coughing up mucus in (b)(6) 2016. A throat culture was performed but no antibiotics were given. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the patient completed her iv antibiotics on (b)(6) 2016 & her picc line was removed. Patient was told that vns could not be re-implanted as she has too much scar tissues. Due to patient's severe allergic reaction to the device & her body rejecting it, the surgeon will not be implant vns again for patient.
 
Manufacturer Narrative

Event Description
Additional information was received from the neurologist that the patient required a revision of her vns in (b)(6) 2015 secondary to a possible allergic reaction to silicone sheathing. She subsequently had slow wound healing. Patient was seen on (b)(6) 2015 after apparently expressing a ruptured suture. It was not felt by the neurosurgeons to be infected at that time. Patient likely developed a uri in (b)(6) 2016 and then developed a left breast cellulitis necessitating removal of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5867152
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dennis100
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« Reply #6 on: August 15, 2018, 03:31:49 AM »

Model Number 303-20
Event Date 08/01/2012
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
The patient's mother reported that the electrode was extruding through the patient's neck. It was reported that the patient was prescribed antibiotics and the patient was scheduled for revision surgery. Clinic notes date (b)(6) 2013 note that the patient forms keloids and has experienced chronic crusting from the site. It was noted that the patient was seen with yellowish discharge from the wound site. It was noted that the wound was not erythematous or swollen. The notes indicate that the wound has a keloid and induration, but is not red. A small area of crusting with no exudate was noted. The patient was sent home with bactrim. Operation notes dated (b)(6) 2012 note that the surgical findings were exposed vagal nerve stimulation tie-down tabs with surrounding inflamed skin and extensive subcutaneous granulation tissue surrounding the deeper tie-down tabs and superficial connecting lead, but no evidence of pus. Clinic notes dated (b)(6) 2013 note that the wound showed a chronic ulceration with exposed connecting lead through the wound. There was no drainage or evidence of infection, although there has been crusting and scabbing along the wound. The patient denies picking at the wound. The patient was seen at the emergency department on (b)(6) 2013 after the wound opened up and was sent home with bactrim. The patient denies any trauma to the area. There is no evidence of drainage. The wound is non erythematous and non tender. The notes indicate that the surgeon is going to try one more time to treat the device in situ with antibiotics solution as well as iv antibiotics. It was noted that if it fails explant will be performed. Operative notes dated (b)(6) 2013 note that the vagal nerve stimulator electrode connecting lead in the anterior cervical region is exposed and there is surrounding inflamed skin and subcutaneous granulation tissue, but no evidence of pus. The wound was debrided and a complex closure was performed. Excision of devitalized granulomatous skin was performed. The notes indicate that the mother reported that the scab had fallen off and the lead wire was exposed; therefore treatment in situ was performed. Multiple antibiotic solutions including vancomycin irrigation, half-strength hydrogen peroxide, lactated ringer's bacitracin solution and also vancomycin crystals were attempted to treat the infection and prevent recurrence. The notes indicate that it is almost as if the patient is rejecting the device. On (b)(6) 2013 it was reported that the patient came in with exposed vns generator and is getting it replaced emergently. The following day it was reported that the surgeon debrided the pocket and that there were no issues with the lead. The surgeon placed prophylactic antibiotics in the pocket and lead area. A new generator pocket was formed and the new generator was placed under the muscle to avoid patient manipulation. The patient was given a picc line for antibiotic. It was reported that if the infection persists the patient may be explanted due to body rejection. The patient's mother believes that the patient's bra underwire may have contributed to the issues initially. Operative notes dated (b)(6) 2013 note that the left anterior chest pocket is infection in the generator area due to skin breakdown and protruding generator. It was noted that the generator pocket had accumulation of purulent fluid likely related to a pinhole sized are of skin breakdown most likely related to rubbing of this area from the patient's underwire bra. It was noted that skin cultures were positive for staphylococcus aureus. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Reporter indicated a patient developed an infection at the vns lead site in the neck. The patient was given antibiotics. Exploratory surgery of the infection site was planned for (b)(6) 2012, but it is not known if this occurred. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had debridement surgery with washout performed on (b)(6) 2012. The two lead tie-downs were removed, as the tie-downs were felt to possibly be causing an allergic reaction which is believed to have caused the infection. The tie-down areas were purulent and irritated. The lead body (not electrodes) was repositioned in a different area away from the infected area. The vns was left programmed on. The patient had no known trauma, and the patient is healing well. Wound cultures were performed which grew out (b)(6) bacteria.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2768901
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dennis100
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« Reply #7 on: August 15, 2018, 03:32:24 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2017
Event Type  Injury   
Event Description
A research article comprised of data from a hospital's registry of all vns patients implanted between december 2010 and march 2016 reported several adverse events. This report captures the adverse events attributed to the generator in the abstract of the article. The adverse events attributed to the lead in the article abstract are captured in mfr. Report # 1644487-2018-00123. One patient experienced aspiration pneumonia subsequent to recurrent nerve paralysis (captured in mfr report 1644487-2018-00123). Another patient reportedly rotated the generator beneath the skin, resulting in a lead fracture and subsequent vns explant surgery. Three patients experienced surgical site infections which resulted in vns explant surgeries. Per the article, the incidence rate of infections reported was 2. 2%. It was reported that an allergic reaction to the vns device may have caused one of the observed infections. No additional relevant information has been received to date.
 
Event Description
A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in this report, mfr. Report #1644487-2018-00122. It was determined that the infections were previously reported to the manufacturer and are captured in mfr. Report # 1644487-2013-02562, # 1644487-2013-03225, and # 1644487-2015-06368. The reported patient-influenced migration and subsequent lead fracture was previously reported to the manufacturer and is captured within mfr. Report # 1644487-2018-00289. No additional relevant information has been received to date.
 
Manufacturer Narrative
Uchida, d & yamamoto, t. (2017). Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients. No shinkei geka, 45(12):1051-1057. Doi: 10. 11477/mf. 1436203646.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7206559
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dennis100
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« Reply #8 on: August 15, 2018, 03:32:57 AM »

Model Number 102
Event Date 11/22/2010
Event Type  Injury   
Event Description
On (b)(6) 2013 it was reported that the patient had a full revision in 2010 and since then has reported pain in both of her arms and chest/ rib cage area. The physician disabled the patient's vns device for a brief period; however, they could not determine the relationship to vns or if the pain was related to stimulation. It was also reported that the patient had an extreme allergic reaction to the anesthesia during the full revision, but the connection to vns and the reports of pain were unclear. The patient's last known settings were provided and it was noted that ifi = no. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Event Description
On (b)(6) 2013, the nurse from physician's office called back about the patient. She stated that the patient is still in pain. The patient was tested for infections, musculersclerosis, "everything", but everything turned out negative. It was reported that it was possible it could be pain syndrome, but the cause of the pain is unknown. On (b)(6) the patient's device was turned off; however, the patient was still experiencing pain. It was concluded that the pain was not associated with stimulation on times and the nurse stated that they could not see any relationship between the pain and vns. It was also reported that the patient had shortness of breath related to the vagus nerve. Physical therapy was suggested to the patient for thoracic syndrome and the nurse stated that they would be following up with that. The patient also has anxiety issues, which was a possible contributing factor, per the nurse. In regards to the allergy, the patient was given benadryl and referred to the primary care physician. There was no verification from physician's office that anything was done. The nurse clarified that the parent reported there was an allergic reaction, but there was no documentation to support that there ever was such a reaction. The only information the physician has on the allergy was the parent's report. The patient is experiencing pain in the knees, chest, and arms. There have been no medication changes or external factors (from a neurological standpoint) that would have caused or contributed to the event. No direct correlation has been found for the cause of the pain. The nurse stated that at this point everything is speculation. No other information was provided.
 
Event Description
It was indicated through a periodic programming history database review that the patient's device was found to be disabled as of (b)(6) 2018. Upon follow-up with the patient's physicians, it was noted from the patient's first and only appointment at that office that the patient had reported concern of pain around the vns and that she wanted the device explanted. The device was disablement at this visit due to the reported pain. No further relevant information has been received to date.
 
Manufacturer Narrative
Report source: follow-up report #2 inadvertently did not indicated company representative as a report source.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3194207
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dennis100
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« Reply #9 on: August 15, 2018, 03:33:28 AM »

Model Number 103
Event Date 10/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Additional information was received that the patient's device was turned on during (b)(6) 2014 and that the patient is doing well. Patient also experiences pinching sensation in her chest during stimulation and when she lies down. Patient's pain when turning her head was reported to be better and was attributed to be due to patient having a bulging disc.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300491
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dennis100
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« Reply #10 on: August 15, 2018, 03:33:57 AM »

Event Date 01/01/2008
Event Type  Injury   
Event Description
It was reported that the vns patient underwent surgical explant of the vns system in 2008 or 2009. It was reported that the generator had been disabled one month prior to the explant because the patient's parents had the impression that seizures had been exacerbated by vns stimulation and they also felt that the patient was allergic to the devices. Attempts to obtain further information have been unsuccessful to date. No explanted device was returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5083838
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dennis100
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« Reply #11 on: August 15, 2018, 03:34:25 AM »

Model Number 105
Event Date 10/01/2015
Event Type  Injury   
Event Description
It was reported that a lead tie-down had extruded from the patient's neck, which required revision surgery on (b)(6) 2015. The patient reportedly had slow wound healing secondary to possible allergic reaction to silicone prior between implant and this occurrence. Additionally, it was reported that a mammogram procedure in this time period had led to migration of the leads and generator. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5924594
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dennis100
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« Reply #12 on: August 15, 2018, 03:34:59 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2017
Event Type  Injury   
Event Description
A research article comprised of data from a hospital's registry of all vns patients implanted between december 2010 and march 2016 reported several adverse events. This report captures the adverse events attributed to the generator in the abstract of the article. The adverse events attributed to the lead in the article abstract are captured in mfr. Report # 1644487-2018-00123. One patient experienced aspiration pneumonia subsequent to recurrent nerve paralysis (captured in mfr report 1644487-2018-00123). Another patient reportedly rotated the generator beneath the skin, resulting in a lead fracture and subsequent vns explant surgery. Three patients experienced surgical site infections which resulted in vns explant surgeries. Per the article, the incidence rate of infections reported was 2. 2%. It was reported that an allergic reaction to the vns device may have caused one of the observed infections. No additional relevant information has been received to date.
 
Event Description
A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in this report, mfr. Report #1644487-2018-00122. It was determined that the infections were previously reported to the manufacturer and are captured in mfr. Report # 1644487-2013-02562, # 1644487-2013-03225, and # 1644487-2015-06368. The reported patient-influenced migration and subsequent lead fracture was previously reported to the manufacturer and is captured within mfr. Report # 1644487-2018-00289. No additional relevant information has been received to date.
 
Manufacturer Narrative
Uchida, d & yamamoto, t. (2017). Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients. No shinkei geka, 45(12):1051-1057. Doi: 10. 11477/mf. 1436203646.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7206559
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« Reply #13 on: August 15, 2018, 03:35:30 AM »

Model Number 102
Event Date 10/01/2007
Event Type  Injury   
Event Description
It was reported that the vns patient underwent a surgery for explantation of the device due to an infection. It was reported that the generator and the lead were both explanted. Follow up with the physician revealed that the patient's implant surgery was in (b) (6) 2007, the patient had developed an infection. Cultures were taken prior to the explantation surgery and the results revealed a "+" infection confirming the event. The explant surgery took place in (b) (6) 2007. In addition, physician's office notes revealed that the patient had also developed an allergic reaction, and dehiscence wound following the implant surgery. Further follow up with the physician revealed that all the events occurred due to the patient picking at his wound. The explanted products were returned to the manufacturer and product analyses have been completed. No anomalies were identified with the products that could have contributed to the reported event. The patient was recently implanted with a brand new 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=1590826
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« Reply #14 on: August 19, 2018, 01:15:09 AM »

Model Number 102
Event Date 04/04/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after her prophylactic generator replacement surgery, she developed an allergic reaction to antibiotics prescribed by neurosurgeon as a precaution. The pt was hospitalized for 3 days ((b)(6) 2011). Also, while she was hospitalized, she was told that her ekg was abnormal which necessitated referral to cardiology, capture in mdr #1666487-2011-00976. Pt also reports hand tremor, cognitive issue and memory problems since the generator replacement. Good faith attempts to obtain more information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082998
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« Reply #15 on: September 07, 2018, 10:17:50 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient had concerns regarding complications with her suture post-operatively. The patient was seen by the neurosurgeon for post-operative follow-up and it was seen that at her left chest incision the suture had popped out and there was some pus and drainage. The cause of the suture popping out and the pus/drainage was stated to be likely an allergic reaction to the suture. There was no signs of infection as there was no fever or swelling just some irritation and mild pus and drainage. However, she was prescribed keflex for 7 days and when she followed up the incision was healing fine. The design history record for the implanted generator and lead were reviewed and confirmed to have been hp sterilized prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7768290
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« Reply #16 on: September 07, 2018, 10:18:27 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2017
Event Type  Injury   
Event Description
Patient underwent generator and lead removal due to allergic reaction and extrusion. Patient also experienced vocal cord paralysis, which the surgeon suspects to be related to the allergic reaction. Patient's voice could be barely heard the day after he was implanted. Patient's voice has not improved much since then. The generator was removed because "it literally came out" of patient's chest. Per caregiver, patient has been a good healer in the past and has had multiple procedures without incident. The incision sites did not heal and there was oozing at the sites. The lead wire was sticking out of his chest as well and, so the lead was removed. Per surgeon, the vocal cord paralysis was noted prior to generator removal. The leads were not manipulated at that surgery and were left in the chest. The allergic reaction was present in both the chest and neck sites. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7824665
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« Reply #17 on: September 12, 2018, 02:25:47 AM »

Model Number 103
Device Problem Patient-Device Incompatibility
Event Date 08/24/2011
Event Type  Injury   
Event Description
Additional information was received from a nurse with the surgeon's office indicating that the issue was first identified on (b)(6) 2011. The patient's home health nurse reported to the surgeon's office that the patient's wound was draining yellow purulent fluid. At that time, the patient was admitted to the hospital. Manipulation is not suspected as the patient is handicap and cannot reach her chest or generator site. The surgeon felt that issues were caused by tissue deterioration from an allergic reaction to the generator. Cultures were taken of the wound site and were found to be negative for growth. The lead and generator were both explanted on (b)(6) 2011. After the explant, the patient was sent home on antibiotics. The patient was then seen again on (b)(6) 2011 as her wound had re-opened and was again draining fluid. The patient was put on another dose of antibiotics however cultures were not taken. The nurse indicated that if the infection did not resolve they may have to admit the patient and administer stronger (intravenous) antibiotics to try to resolve the infection. There are currently no plans for replacement, however the surgeon did indicate that if they did chose to re-implant in the future, they may chose a different implant location. The nurse indicated that the issues were solely isolated to the chest area with no problems or infection in the neck. When the patient was seen on (b)(6) 2011, the neck incision was healing with no issues. The patient's generator model and serial number were also provided by the surgeon's office. The device history record was reviewed for the patient's generator and sterility was confirmed prior to shipment. During the follow-up with the nurse on (b)(6) 2011, it was reported that the patient's lead was extruding through the patient's chest wall. This event is reported under mdr number: 1644487-2011-02717.
 
Event Description
The explanted generator was received on (b)(4) 2015. Analysis has not been completed to date.
 
Event Description
It was reported that the patient was experiencing an allergic reaction to the metal used in the vns. Device explant was required, however the date of explant is currently unknown. Attempts for additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2012 an operative report from the day of surgery was received and indicated that the patient had "breakdown of her wound and then some drainage". She was not having a fever. The patient's generator and lead were explanted at that time and it was indicated that the tissue quality was "quite poor". It was also noted that hardware could be seen through the wound. It is unclear if the hardware that could be visualized was the generator or the lead. Additional information was then received on (b)(4) 2012 that the patient was healed and ready for implant, which then occurred on (b)(6) 2012.
 
Manufacturer Narrative

Event Description
Analysis was completed, and no anomalies were identified with the generator. The generator was left on after explant, and the generator was pulse disabled upon receipt. A battery life calculation estimated 0 years remaining battery life.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2293177
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dennis100
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« Reply #18 on: October 05, 2018, 12:25:34 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2018
Event Type  Injury   
Event Description
It was reported by a medical professional that a vns patient¿s incision had opened. After evaluation by the surgeon, it was believed the cause of the site opening was that the patient was having an allergic reaction to the sutures. The patient was scheduled for surgery to debride and restitch the wound. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842172
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dennis100
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« Reply #19 on: October 06, 2018, 05:06:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/10/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns lead wire was extruding from his neck. The physicians wanted to explant the device as a result. Follow up by the tc revealed that there was no trauma or patient manipulation that could have contributed to the event. The physician's office believed that the patient was allergic to the vicryl sutures placed after surgery as the patient has been in almost weekly since the date of implant due to his body rejecting the sutures and pushing them out of his skin. It was stated that this caused abscess type problems around the generator and neck and that the patient has been back in previously to remove the sutures and clean the surgery site. It was later reported that the patient responded well to vns therapy, but had significant swelling around the generator and approximately 2 inches of the lead was protruding. The surgeon decided to explant the whole vns system and give the patient time to recover from the infection. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877560
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dennis100
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« Reply #20 on: October 22, 2018, 02:09:55 PM »

Model Number 304-20
Event Date 06/15/2012
Event Type  Injury   
Manufacturer Narrative
Date of explant, corrected data: additional information was received indicating that the patient underwent explant on (b)(4) 2012. This report is being submitted to correct this field.
 
Event Description
It was reported to the manufacturer by the patient's caregiver that the vns generator and lead were explanted, but the date is unknown. The date of (b)(6) 2012 will be used as a placeholder. It was felt the infection could not be controlled without explanting the vns per the caregiver. The generator was discarded, but the lead is in possession of the caregiver who wishes to return it to the manufacturer. The lead's electrodes were encapsulated on the patient's left vagus nerve and were not removed.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.
 
Event Description
On (b)(6) 2013, the patient's caregiver reported that the patient underwent explant on (b)(6) 2012. Attempts for product return have been unsuccessful as the caregiver opts to perform independent testing on the explanted device.
 
Event Description
Reporter indicated a patient developed an infection at the vns electrode incision site in the neck. The exact day and month of the patient's birth were not provided. The patient was originally implanted with the vns on (b)(6) 2012. The patient had a fall on (b)(6) 2012 and developed redness subsequently at the electrode site. The incision became red and the scar became larger, but the wound did not open up. Intravenous antibiotic treatment was given. The patient later had debridement surgery on (b)(6) 2012, when it was noted necrotic fat tissue was present next to the area of lead fixation. The patient was placed on antibiotics for an additional 7 days, and the scar reddened again and thickened. The reporter is questioning whether there may be an allergic reaction to the tie-downs used to secure the lead. The patient had an additional surgery on (b)(6) 2012, where the tie-downs only were removed, and the lead was then fixed to the muscle using non-absorbable suture. Wound cultures were done of the open wound which grew out (b)(6) bacteria. The wound is now closed and healing well.
 
Manufacturer Narrative
Report source, corrected data: the initial mdr report inadvertently omitted the "foreign" designation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2727179
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« Reply #21 on: January 20, 2019, 02:37:19 AM »

Model Number 105
Event Date 06/20/2014
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
Analysis of the generator was completed on 07/31/2014. 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. The physician reported that the patient's incisions look great and there are no problems.
 
Event Description
It was reported that the recently implanted vns patient underwent surgery to explant his generator on (b)(6) 2014. At the time, it was believed that the patient had developed an infection. It was later determined that the patient did not have an infection but had an allergic reaction to tape. The patient was re-implanted with a new generator on (b)(6) 2014. The explanted generator has been returned to the manufacturer where analysis is currently underway. 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=3954990
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« Reply #22 on: February 07, 2019, 09:10:51 PM »

Event Date 12/22/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the patient¿s vns implant surgery was cancelled due to anaphylaxis reaction to anesthetics. The procedure hadn¿t started yet. They treated the patient, woke her up, and then admitted her. It was noted that they would run some allergy testing and reschedule her later.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4422592
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dennis100
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« Reply #23 on: February 09, 2019, 02:25:49 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/10/2018
Event Type  Injury   
Event Description
It was reported that this patient generator was explanted due to an infection at the generator site and pocket, but the leads were left intact. It was stated that it became infected because the patient was allergic to the adhesive used by the surgeon. 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 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.
 
Manufacturer Narrative
Device evaluation is not necessary as the infection 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=8273219
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« Reply #24 on: February 09, 2019, 02:26:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2018
Event Type  Injury   
Event Description
It was reported by the patient that they experienced an allergic reaction following vns surgery and went to the emergency room. The patient indicated that they experienced severe swelling at the chest and neck site as well as difficulty breathing related to their allergic reaction. The physician indicated that the patient had a rash around the surgical sites related to the patient being allergic to the agent used to prepare the surgical site prior to surgery, chlorhexidine prep. The physician indicated that the patient was also allergic to the doxycycline antibiotics consumed. A review of the device history records showed that both the lead and generator were sterilized prior to distribution. No further relevant information has been received 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8251305
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dennis100
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« Reply #25 on: February 11, 2019, 02:08:18 AM »

Model Number 105
Event Date 12/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient developed a painful mass above the generator site several weeks ago. The patient denied any trauma to the area. The mass was not warm or red and did not appear infected. Follow-up revealed that the patient developed inflammation at the generator site potentially due to a local allergic response. Interventions have been taken to preclude a serious injury. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4493768
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dennis100
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« Reply #26 on: February 25, 2019, 02:33:33 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2015
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturer device history records confirmed sterilization was performed for the generator and lead prior to distribution.
 
Event Description
Analysis was completed on the explanted products. No anomalies were found with the generator. The device performed according to specifications. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint.
 
Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient had vns explant surgery on (b)(6) 2015 due to an infection of unknown origin. The hospital reported that both the generator and lead were explanted due to site infection with no plans of replacement. Follow-up was performed with the surgeon's office. It was reported that the patient came into the surgeon's office in (b)(6) 2015 with granulation tissue in the area of the healed neck incision. The surgeon debrided the site at that time. The patient presented again in (b)(6) 2015, and he still had granulation tissue at the healed neck incision with blistering at that aspect the neck incision. The wound was healed, but granulation tissue was present with blistering. It was reported that it was more of an allergic reaction rather than surgical infection. Since the event had continued, the surgeon elected to perform a full explant. Cultures were taken of tissue adjacent to the vns area in the neck. Pathology results showed fibrous tissue with gram positive in clusters and pairs.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4766690
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dennis100
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« Reply #27 on: March 20, 2019, 10:55:07 AM »

Model Number 105
Event Date 08/11/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
A physician reported to an international distributor that at a patient developed an infection at the implant site roughly 2 months after vns replacement surgery. The physician is unsure of the cause of the infection but suspects a titanium allergy. The patient experienced no prior allergies, infections, reactions with his prior vns device. The physician elected to remove the pulse generator. Manufacturing records were reviewed for the patient's pulse generator and lead and proper sterilization was verified for each prior to product distribution. The explanted generator was discarded by the explanting facility and is therefore unable to be returned to the manufacturer for product analysis.
 
Manufacturer Narrative
Uchida, d & yamamoto, t. (2017). Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients. No shinkei geka, 45(12):1051-1057. Doi: 10. 11477/mf. 1436203646.
 
Event Description
An abstract from a research article comprised of post-market surveillance data from a hospital¿s vns patients implanted between december 2010 and march 2016 was (also) received. The abstract indicated that four patients experienced recurrent vocal cord paralysis. The abstract also indicated that one patient experienced subsequent aspiration pneumonia. Three patients underwent explant due to surgical site infections, and one patient underwent explant due to a patient-influenced revolving of the generator which eventually resulted in lead fracture. The recurrent vocal cord paralysis is reported within mfr. Report # 1644487-2018-00123. A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in mfr. Report #1644487-2018-00122. It was determined that the infections were previously reported to the manufacturer and are captured in mfr. Report #s 1644487-2013-02562, 1644487-2013-03225, and 1644487-2015-06368, the last of which corresponds to the events captured within this report. Per the abstract, allergic reaction was suspected to be a cause of the infection captured in this report. The reported patient-influenced migration and subsequent lead fracture was previously reported to the manufacturer and is captured within mfr. Report # 1644487-2018-00289. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5218034
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dennis100
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« Reply #28 on: April 10, 2019, 01:33:29 AM »

Model Number 103
Event Date 03/15/2015
Event Type  Injury   
Event Description
It was reported that a vns patient, implanted since 2014, developed a skin infection in both cervical and chest incisions with a watery discharge, 6 months after the implant. It was reported that after a culture on the biopsy specimen, it was found that there was tuberculosis present. It was reported that the patient got treated for the tuberculosis and was cured from it, but she still has a watery discharge around the cervical and chest incision sites. It was reported that the physician diagnosed the patient as allergic to the vns implant. It was reported that they note that the patient has very good results with vns regarding her epilepsy. No additional information was provided to date.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided an incorrect age/ date.
 
Event Description
It was reported that the vns system works fine and the diagnostic test results are ok. The review of the manufacturing records confirmed the sterilization with the method hp for the generator and the lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5821849
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dennis100
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« Reply #29 on: April 12, 2019, 01:12:33 AM »

Model Number 304-20
Event Type  Injury   
Event Description
It was reported the patient was referred for lead explant due to an allergy to the metal. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5769448
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