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Author Topic: Dehiscence  (Read 21414 times)
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dennis100
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« on: November 15, 2017, 02:08:47 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2016
Event Type Death
Manufacturer Narrative

Event Description
The patient was admitted to the hospital on (b)(6) 2017 due to increased seizures frequency and feeding intolerance. The patient had her medications were increased before the decision was made to induce coma. The patient was trialed on an anesthetic but developed a diffuse reaction, so she was then started on propofol infusion. On (b)(6) 2017 the patient developed severe acidosis and hypotension that resulted in cardiac arrest. The patient was then placed on life support where her kidneys began shutting down. The physician then attempted to improve the patient's electrolytes to help her heart cardiovert. However two attempts failed to cardiovert the patient. An electrophysiologist verified that the patent's heart would not likely recover. The patient's family then elected to remove the patient from life support. The explanted lead and generator were received for product analysis. Migration, wound dehiscence and infection are outside of the scope of product analysis. No anomalies were found with the generator that affected its functionality. Only a portion of the lead was returned and there was no noted discontinuity in the lead. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

Event Description
The patient was scheduled to undergo a replacement surgery. During the replacement surgery the surgeon found that the patient¿s generator had migrated further than the neurosurgeon had anticipated and so he explanted the patient¿s vns in order to allow the pocket to heal. Cultures were taken at the time of the patient¿s surgery to determine if an infection was present. Follow up with the surgeon¿s office indicated that the cultures confirmed infection and that there was skin dehiscence, wound breakdown, and pus observed when the physician opened the patient. The surgeon also noted that the was a bit of trauma that had occurred to the patient¿s skin recently. The patient was discharged after surgery but then came back to the hospital later that day because she was not feeling well. Ten (10) minutes after returning to the hospital the patient went into cardiac arrest where she was placed on life support. The patient¿s organs then began shutting down and the patient passed away. The neurologist ¿s notes were reviewed and there was no mention of attributing the death to vns therapy. The patient's explanted generator has been received and is undergoing product analysis. The surgeon also indicated that he did not use a non absorbable suture to anchor the patient's generator in the subcutaneous pocket. A design history record review found that the patient's generator was sterilized prior to leaving the manufacturing facility. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6292580
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dennis100
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« Reply #1 on: November 15, 2017, 02:09:57 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/23/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient underwent explant of vns. Notes from explant surgery were received indicating that the reason for the explant was due to infection and cellulitis in the neck and chest. Patient presented with complete dehiscence of the neck wound in the early postop period and underwent closure of the wound (previously reported in mfr. Report # 1644487-2016-00905). Since then, patient has developed symptoms of recurrent infection in her neck and chest wounds and this has been refractory to antibiotics. Infectious disease service was consulted and they recommended device explantation and iv antibiotics. During the surgery, the surgeon observed dense scar tissue. As he removed this tissue in the carotid sheath, there was profuse bleeding from the side wall of the internal jugular vein that result in rapid blood loss. The surgeon was able to control this and then repaired the defect in the wall. The electrode was cut after it was removed from around the vagus nerve. The neck wound had dense scar tissue but no fluid or granulation tissue. In the chest, the pulse generator was removed with the cut half of the electrode still attached. The surgeon then removed extensive granulation tissue from the chest wound subcutaneous tissues and muscle. The surgeon obtained fluid from the chest wound and this was sent for culture and sensitivity. The chest wound was debrided and granulation tissue was sent for pathological examination. The neck and chest wounds were copiously irrigated with bacitracin irrigation and the wounds were then closed. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Products were received for analysis but not completed to date.

Manufacturer Narrative
(b)(4).

Event Description
A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications of final configuration r-wave test. 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 condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6330818
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dennis100
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« Reply #2 on: November 15, 2017, 02:11:03 AM »

Model Number 103
Event Date 11/25/2012
Event Type Injury
Event Description
During a return product call from a hospital personnel, it was reported that the patient had generator explant on (b)(6) 2012 due to infection. It was reported by the hospital facility that the lead was not explanted. The generator and lead were later received by the manufacturer for product analysis on (b)(4) 2012. However, product analysis has not been completed to date. Attempts for additional information from the surgeon have been unsuccessful to date. Notes from the manufacturer representative present at vns implant surgery revealed that there were no complications during procedure. Systems diagnostics completed without difficulty.

Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not report the information attained from the surgeon and the return product form.

Event Description
An implant card was later received on (b)(6) 2013 reporting that the patient was re-implanted with vns on (b)(6) 2013 after previously being explanted due to infection. The company representative reported that there were "no issues" during implant.

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

Event Description
Return product form indicated that both the generator and lead were explanted on (b)(6) 2012 due to "patient infection at site. " replacement was not indicated. The surgeon reported on (b)(6) 2012 that the infection and related symptoms (wound dehiscence with pus) were first observed on (b)(6) 2012. The infection was at the generator site, and the surgeon indicated the infection was believed to be related to the presence of the device. The patient may be re-implanted in the future. No patient manipulation or trauma occurred that is believed to have caused/contributed to the infection. Cultures were taken to confirm the infection, so antibiotics were administered. The results indicated "no growth. " product analysis of the generator and lead was completed. 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. An analysis was performed on the returned lead portion. Note that the lead assembly (body) including the electrodes was not returned for analysis and therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2881940
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dennis100
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« Reply #3 on: November 15, 2017, 02:11:56 AM »

Model Number 304-20
Event Date 05/01/2013
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013 as captured in manufacturer report number: 1644487-2013-01380. Clinic notes dated (b)(6) 2013 indicated that the patient continued to have coughing episodes and paroxysms of events where she is pointing to her throat. On exam, the patient had increased salivation. Therefore, the vns was taken off of rapid cycling several days ago and programmed at 1. 5 ma. The settings on this visit were then programmed to 1. 0 ma, 30 sec on time, 5 min off time, and 5 hz frequency. Later, clinic notes dated (b)(6) 2013 indicates the mother reported improvement in the patient¿s condition, but the patient continued to experienced cough and intermittently associated emesis. The cough was described as occurring throughout the day, but is most notable at night. She was evaluated by her primary care physician the previous day without provider concerns for intercurrent illness. The mother reported significant difficulties with oral feedings which have were also since device replacement and had timed periods of 5 minutes during which there are no difficulties followed by cough with or without emesis. The neurologist was informed of the issues from the treating nurse and agreed with the surgeon¿s recommendation for a period of rest for the vagus nerve. The vns output current and magnet current were both turned to 0 ma during the visit. The plan was to allow one week of vagal nerve rest. Later, notes dated (b)(6) 2013 report that the patient was admitted with a superficial vns wound infection with wound discharge. She was admitted for wound washout, exploration, and revision. Neurosurgery discharge notes dated (b)(6) 2013 indicate the patient was admitted with diagnosis of surgical wound dehiscence status post-vns replacement, with poor oral intake. The patient was discharged on (b)(6) 2013 with diagnosis of surgical wound dehiscence status post-vns replacement, left vocal cord paralysis, and poor oral intake. The hospital course notes indicate the patient had stimulator replacement on (b)(6) 2013 due to ¿vns malfunction,¿ as captured in manufacturer report number: 1644487-2013-01380. The patient presented to the clinic on (b)(6) 2013 with slight separation of the wound and small amount of white drainage for one day. The mother denied any fevers and seizures. The patient was having a lot of gagging and has not been tolerating any food intake. She lost a few pounds in the prior few days. An ent performed a laryngoscopic exam on the patient on (b)(6) 2013 which demonstrated paralyzed left vocal cord in the paramedian position with mild paryngomalacia. The patient was taken to the operating room on (b)(6) 2013 for a wound washout and revision. Her wound was only superficially dehisced and there was no purulent material seen. An ng tube was placed intraoperatively for nutritional supplemental. During the course of her hospitalization, speech therapy as well as a dietary consult was obtained. Serum electrolytes were monitored to ensure the patient did not develop any electrolyte imbalances from re feeding syndrome. Per speech therapy evaluation, the patient was to be continued on ng feeds. Intraoperative cultures of her wound were negative for bacterial growth. The plan was to complete a 7 day course of keflex. The patient¿s mother was instructed how to perform the ng tube feeds. At time of discharge, the patient was afebrile, voiding, tolerating her ng tube feeds, had good pain control and at her neurological baseline. The plan was for the patient to be admitted for long term monitoring which time speech therapy will be re-evaluating her swallowing function. Attempts for additional information are in progress but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3162932
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dennis100
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« Reply #4 on: November 15, 2017, 02:12:42 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 #5 on: November 15, 2017, 02:13:26 AM »

Event Date 05/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient had picked at the neck incision site and pulled out the leads. Patient managed to pick open his neck incision and was seen on (b)(6) 2015. The physician was able to see some of suture underneath the and determined it best to explant the device as patient might end up pulling out a portion of the vns with a risk of infection. Patient underwent full explant on (b)(6) 2015. Additional information was received that the patient previously picked the chest incision site causing wound dehiscence. This is reported in manufacturer report # 1644487-2015-04803.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4803482
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dennis100
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« Reply #6 on: November 15, 2017, 02:14:39 AM »

Model Number 106
Event Date 04/12/2016
Event Type Injury
Event Description
It was reported that a patient that was recently implanted with vns was hospitalized due to an infection that required removal of the vns system. Clinic and operative notes were received on 04/21/2016 regarding the patient's infection. The patient had vns implant surgery on (b)(6) 2016 and was admitted to the hospital on (b)(6) 2016 due to nausea, chills, pain at the neck and chest incisions, odynophagia, and pain while moving her neck. The patient started having drainage at the neck area. After the patient was admitted to the hospital, it was determined that the patient had fever, tachycardia, and leukocytosis. There was evidence of inflammatory changes/edema in soft tissue of the left check and neck. The patient was diagnosed with sepsis secondary to left chest wall cellulitis. The patient's vns system was explanted on (b)(6) 2016 due to the infection. The patient was treated with antibiotics for a streptococcus pyogenes (group a). The patient was admitted to the hospital for surgery on (b)(6) 2016 due to "issues" with her incision. The patient was experiencing wound dehiscence at her neck incision after her vns system was explanted. Irrigation and debridement of the cervical wound and a revision of the wound was performed. It was not known if the wound dehiscence was a continuation of the previous infection, but it was stated that it could have been due to possible poor wound healing. The device history records of the lead and generator were reviewed, and both were sterilized according to procedure prior to release.

Event Description
Ct scans performed during the patient's visit on (b)(6) 2016 were provided on (b)(6) 2016. The indication for the ct scan was recent removal of implant for seizures with draining incision in the neck. The ct of the chest identified focal induration within the left breast which was nonspecific. There was no pathologically enlarged adenopathy or mass. In the neck. There was no evidence of discrete fluid collection or mass. The ct of the neck identified a small air-filled cavity in the anterior aspect of the neck along the medial aspect of the left sternocleidomastoid muscle. There was no discrete fluid collection to suggest abscess. The patient also had a picc line placed from the right arm for the infection.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5655090
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dennis100
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« Reply #7 on: November 15, 2017, 02:16:09 AM »

Model Number 104
Event Date 12/13/2011
Event Type Malfunction
Manufacturer Narrative

Event Description
Reporter indicated the increased seizures the patient experienced were due to the high lead impedance. The seizures were not above pre-vns baseline level and the seizure type was not known.

Manufacturer Narrative
Describe event or problem, corrected data: information regarding the increased seizures was inadvertently omitted from follow-up mdr #1.

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

Event Description
Per the patient's caregiver, on (b)(6) 2012, the patient's incision sites appeared purple and the patient had debridement and irrigation of the vns generator area, and the generator was moved to a new pocket. The patient then had vns prophylactic generator and lead replacement surgery performed on (b)(6) 2012, due to desiring a newer vns model. The vns may have been placed in the right chest due to the patient's continued wound healing problems and possible infection. An implant card was received indicating the vns generator and lead had been replaced due to "malfunction". The explanted vns generator and lead remnant were received for analysis on (b)(6) 2012 and are pending analysis. The vns generator was interrogated successfully in the product analysis lab and did not display any abnormalities upon interrogation. Attempts for further information regarding the wound healing and possible infection are in progress.

Manufacturer Narrative

Event Description
Reporter indicated the new vns generator was implanted in the right chest due to the previous poor healing issues in the left chest incision area. The new lead was tunneled diagonally across the chest. It was unknown what to attribute the poor wound healing to, as the patient had no trauma and it was not felt there had been any device manipulation by the patient. The patient was last seen on (b)(6) 2012, and has been released back to the care of her neurologist, with instructions to call the surgeon's office if issues arise. There have been no calls about the patient since she was seen on (b)(6) 2012. There was no infection present in the wound, but the lead was extruding through the skin prior to the (b)(6) 2012 surgery. The cause of the poor wound healing is unknown, and there was no known trauma or device manipulation by the patient. Additional manufacturer follow up with the treating neurologist's office revealed, the patient is doing well since the surgery, and there have been no issues with the wound healing. Product analysis of the explanted lead and generator was completed. Note that since the majority of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the pin surface. However, the generator and lead were received connected together, and the generator was programmed on; the generator was outputting to an open load. Other than the above mentioned observations and the typical wear and explant related observations, no product related anomalies were identified in the returned lead portion. Results of generator diagnostic testing and monitoring indicated the device was operating properly and that the battery was at an "ifi = yes" condition. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Reporter indicated a patient presented on (b)(6) 2011, with swelling around the vns generator site, increased seizures, and high lead impedance with vns diagnostics testing. The patient recently had vns generator replacement surgery performed on (b)(6) 2011, and all vns diagnostics were normal at the surgery. The patient had vns lead pin reinsertion surgery performed on (b)(6) 2011, which resolved the high lead impedance. It was noted during the surgery that one of the lead pins had "popped out" of the generator header. The lead pins were then secured appropriately into the generator header. Vns diagnostics following the lead pin reinsertion were within normal limits. Attempts for further information are in progress.

Event Description
Reporter indicated the patient's vns generator site incision had opened up (wound dehiscence), and the vns lead was visible within the wound. There was not an infection present, and it is unknown why the wound opened up. There was no trauma, and it is not felt the patient manipulated the vns, though she is developmentally delayed. There does not appear to be any hygiene issues, as it was felt the patient was very well cared for at home by her mother. The patient had exploratory surgery performed on (b)(6) 2012. The patient is on antibiotics because she had an open wound. At the (b)(6) 2012, surgery, the wound was washed out and debrided and closed, but no devices were explanted. The patient was seen on (b)(6) 2012 and is doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2408227
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« Reply #8 on: November 15, 2017, 02:16:54 AM »

Model Number 105
Event Date 07/22/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead. The patient had been scratching at his cervical wound site which subsequently led to extrusion of the electrode. It was noted that the patient had a history of combativeness, aggressiveness, and self-mutilating behavior. The patient went to the er where approximately 6cm of the patient¿s lead was found to be visibly extruding from the approximate 6mm opening of the patient¿s wound. There was no purulence but the patient was sent for surgery due to risk of infection. During explant, granulation tissue was found at the area of dehiscence and a significant amount of scarring was noted within the patient¿s neck. The extruding portion of the patient¿s lead was cut and discarded. Samples were taken for cultures and the patient¿s wound was cleaned and irrigated. The patient has not been re-implanted to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4131361
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« Reply #9 on: November 15, 2017, 02:17:33 AM »

Event Type Injury
Event Description
An article titled ¿vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis¿ was received which included the vns patient adverse events. Two patients experienced post-operative infections that were treated with iv antibiotics, one of which required device explant. One patient had wound dehiscence one week following surgery that was surgically treated. One patient had to undergo surgery to reposition the device due to protrusion. One patient underwent surgery due to a lead issue. Five patients were noted to have experienced significant weight loss due to decrease in appetite. Analgesics did not improve oral intake in the noncommunicative patients, and in one patient decreasing the stimulation intensity did help. Two patients were non-responders but experienced significant weight loss that required either device removal or disablement. This manufacturer report involves the wound dehiscence that was surgically treated.

Manufacturer Narrative
Vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis. Aburahma, samah k. Et al. Seizure - european journal of epilepsy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377796
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« Reply #10 on: November 15, 2017, 02:18:33 AM »

Model Number 102
Event Date 09/15/2014
Event Type Injury
Manufacturer Narrative
Evaluation not related to event.

Event Description
Additional information was received that product analysis was completed on the lead. A coil break was identified in both the positive and negative lead coils. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends. Secondary fractures were observed in at least two strands of the quadfilar coils. The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter. Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿. The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead. The report issue found with the lead was reported on medwatch 1644487-2014-02836.

Event Description
Additional clinic notes dated (b)(6) 2014 were received stating that the patient experienced wound dehiscence following the explant surgery on (b)(6) 2014. Patient's stitches were taken out and replaced with steri-strips. The patient's chest incision was reported to be open with yellow drainage from it. Patient was provided with antibiotics and was noted to be seeing the surgeon in a few days.

Event Description
It was initially reported that the patient had their vns explanted. After the explant, the patient picked at the incision and opened the pocket. There was nothing implanted in the patient at that time of the incision being picked open.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4147147
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« Reply #11 on: November 15, 2017, 02:19:17 AM »

Event Date 01/02/2017
Event Type Injury
Event Description
An article was received that reported multiple adverse events and a malfunction. The current report captures the adverse events associated with the generator. Mfr. Report # 1644487-2017-04155 captures the malfunctions reported by the article. Mfr. Report # 1644487-2017-04154 captures adverse events associated with the lead. There was one intraoperative adverse event associated with the generator. This patient experienced transient asystole intraoperatively. This event resolved without treatment and did not require cardiopulmonary resuscitation. There were three reported post-surgical complications related to the generator. There was one patient that presented with wound dehiscence one week post-surgery that was managed surgically. Another patient presented with an infection at both generator and neck sites; this patient had full recovery after being treated aggressively, first with iv antibiotics for one week and second with oral antibiotics for another week. The last patient experienced post-operative status epilepticus that required 3 days intubation and icu admission; this was most probably related to general anesthesia used during surgery. The article reported that 10 patients experienced laryngeal side effects associated with stimulation (coughing, hoarseness and shortness of breath) that were proportional to amplitude, frequency and duration of stimulation. These patients all presented with a significant increase in vocal handicap index. These patients were found to have decreased left cord mobility that was more significant with vocal cord abduction. The left cord in the resting position was shorter and more medially-positioned than the right vocal cord. None had complete vocal cord paralysis and their voice changes did not affect their ability to communicate and shortness of breath was mild. None needed medical or surgical treatment. Vocal hoarseness resolved in patient's no longer receiving therapy. One patient experienced an increase in seizures with vns therapy. The patient' caregivers requested vns removal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6723189
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« Reply #12 on: November 15, 2017, 02:20:09 AM »

Model Number 104
Event Date 12/28/2014
Event Type Injury
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: follow-up report #1 inadvertently did not list the received date of (b)(4) 2015.

Event Description
It was reported that the patient experienced wound dehiscence following generator replacement on (b)(6) 2014. The surgeon saw the patient on (b)(6) 2014 and there were no signs of infection. Prophylactic antibiotics were given. The wound was reported to be 90% healed on (b)(6) 2015. No additional relevant information has been received to date.

Manufacturer Narrative
Udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532251
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« Reply #13 on: November 15, 2017, 02:20:52 AM »

Event Type Injury
Manufacturer Narrative
Vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis. Aburahma, samah k. Et al. Seizure - european journal of epilepsy.

Event Description
An article titled ¿vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis¿ was received which included the vns patient adverse events. Two patients experienced post-operative infections that were treated with iv antibiotics, one of which required device explant. One patient had wound dehiscence one week following surgery that was surgically treated. One patient had to undergo surgery to reposition the device due to protrusion. One patient underwent surgery due to a lead issue. Five patients were noted to have experienced significant weight loss due to decrease in appetite. Analgesics did not improve oral intake in the noncommunicative patients, and in one patient decreasing the stimulation intensity did help. Two patients were non-responders but experienced significant weight loss that required either device removal or disablement. This manufacturer report involves the device protrusion which required surgery to reposition the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377788
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« Reply #14 on: November 15, 2017, 02:21:45 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 12/28/2016
Event Type Injury
Event Description
It was reported that the patient experienced an allergic reaction to tacaderm and dermabond following the previous vns generator replacement. Due to this the patient's wound became infected and the patient required several weeks of bed rest for the wound to heal. Clinic notes were later received that the patient had wound breakdown which required wet to dry packing for a couple of months. It was also reported that the patient may have opened her wound during a pseudoseizure after the replacement which contributed to the post-op complications. A review of the internal manufacturing records showed that the generator was sterilized prior to distribution. It was also reported that the patient's generator had migrated after the implant surgery which is reported in mfg report # 1644487-2017-04286. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary because the reported events of dehiscence, infection, and allergic reaction have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6789883
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« Reply #15 on: November 15, 2017, 02:22:32 AM »

Model Number 106
Event Date 09/29/2016
Event Type Injury
Event Description
It was reported the patient had her vns explanted on (b)(6) 2016 as her incision had broken open. The surgeon was concerned that everything was infected. Originally, it was unknown how the dehiscence occurred; however, it was later found that the patient had fallen on an unknown date, which caused the generator site incision to open. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

Manufacturer Narrative
(b)(4).

Event Description
It was later reported that after the patient's device was explanted she began to have an increase in seizures. The increase in seizures was caused by the loss of therapy as the device was explanted due to the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6036101
« Last Edit: December 31, 2017, 02:17:31 AM by dennis100 » Logged
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« Reply #16 on: November 15, 2017, 02:23:36 AM »

Model Number 102
Event Date 11/20/2012
Event Type Injury
Event Description
Additional information was received on (b)(4) 2012 when the implanted generator product information was received from the implanting hospital.

Manufacturer Narrative
Date of explant; corrected data: this information was found to have been incorrectly reported on initial mfr. Report. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Further follow-up revealed that the generator was not explanted in (b)(6) 2012 as previously reported. It was reported that the generator and lead were explanted on (b)(6) 2013 due to recurring infection. It was reported that the devices were not replaced. The generator and lead were returned for analysis on (b)(4) 2013. The returned product form listed recurrent infection and cervical pain as the reason for explant. It was reported that the patient experienced dehiscence of unknown cause in (b)(6) 2012 and that at that time explant was likely, but that the explant was not performed until now. The physician indicated that the patient experienced recurrent infection at the generator site times two (once in (b)(6) 2012 and then again in (b)(6) 2012). It was reported that the device was removed at the request of infectious disease physician. The physician indicated that the generator replacement in (b)(6) 2012 is believed to have caused or contributed to the infection. Cultures showed no organisms with occasional neutrophils with growth after 5 days. The lead pa was completed on (b)(4) 2013. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The generator pa was completed on (b)(4) 2013. The pulse generator performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

Manufacturer Narrative

Event Description
On (b)(6) 2012 it was reported that the patient was recently re-implanted with a generator and there was dehiscing at the wound site. The patient had the generator removed the next day. (b)(4) attempts for further information from the physician were made but were unsuccessful. The patient's implanted generator product information was requested from the hospital but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2871524
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« Reply #17 on: November 15, 2017, 02:24:31 AM »

Model Number 103
Event Date 06/08/2012
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
On (b)(6), 2012, this vns patient reported that she was implanted on (b)(6), 2012. The patient was implanted in (b)(6) and remained there for two days post operatively for an incision check, at which time she was well. One day after returning to (b)(6), the patient began to feel ill and was taken to the emergency room. The patient was admitted for pneumonia and incision infection. The patient stated that she spent two days in the hospital and received multiple antibiotics. When the patient reported this event on (b)(6), 2012, she stated that she was back at home, that she was feeling better, and that the incisions were looking better. On (b)(4), 2012, manufacturer records were reviewed. It was confirmed that both the generator and lead were sterilized prior to distribution. On (b)(6), 2012, follow up with the admitting hospital revealed that the patient had been admitted on (b)(6), 2012 and discharged on (b)(6), 2012. Attempts for additional information have been unsuccessful to date.

Event Description
On (b)(6) 2012, follow up with the admitting hospital's director of infection was performed. The director obtained information from the patient's charts and stated that the patient was admitted on (b)(6) 2012. The patient came in with pneumonia and erythema at both the neck and chest incision sites. The patient was given antibiotics and intravenous fluids. Blood cultures were taken with negative results. The patient was diagnosed with left neck surgical wound infection and sepsis. The patient returned on (b)(6) 2012. Dehiscence was seen; however, no interventions were taken as the incision appeared to be healing well. The relation of the pneumonia to vns was unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2646272
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« Reply #18 on: November 15, 2017, 02:26:03 AM »

Model Number 302-20
Event Date 05/05/2008
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
Reporter indicated that vns pt had lead extrusion and infection at the electrode and generator sites. The infection had been present for some time. The infective organism was methicillin-resistant staphylococcus aureus. The pt had previously presented to the emergency room with a deep dehiscence of his cervical incision. The dehiscence resulted from a lanced blister that was a result of tracheostomy tapes near the incision site. The lead extrusion was due to the infection per the reporter. The pt's vns generator and entire lead were explanted. During the surgery, bloody pus and swelling was noted around the generator site, which was indicative of the pt causing self-trauma to the area due to pain. It is not likely the pt will be reimplanted per the reporter. The explanted generator and lead have been returned and are currently in product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1057230
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« Reply #19 on: November 16, 2017, 02:42:54 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 02/14/2017
Event Type Injury
Event Description
The patient's neck incision had dehisced and become infected. The patient was referred to neurosurgery. No known surgical interventions have occurred to date. The design history record was reviewed for sterility. It was noted that the lead was sterilized prior to being distributed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6461018
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« Reply #20 on: November 16, 2017, 02:43:45 AM »

Model Number 102
Event Date 05/01/2010
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 initially reported by the surgeon that the pt picked at the generator incision site and the wound dehisced. Cultures showed positive for staphylococcus. Pt was admitted to the hosp and the device was removed. Design history review was done and it was confirmed that the device was sterile at the time of dispatch from the hosp.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1745787
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« Reply #21 on: November 16, 2017, 02:44:38 AM »

Model Number 304-20
Event Date 05/01/2013
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013 as captured in manufacturer report number: 1644487-2013-01380. Clinic notes dated (b)(6) 2013 indicated that the patient continued to have coughing episodes and paroxysms of events where she is pointing to her throat. On exam, the patient had increased salivation. Therefore, the vns was taken off of rapid cycling several days ago and programmed at 1. 5 ma. The settings on this visit were then programmed to 1. 0 ma, 30 sec on time, 5 min off time, and 5 hz frequency. Later, clinic notes dated (b)(6) 2013 indicates the mother reported improvement in the patient¿s condition, but the patient continued to experienced cough and intermittently associated emesis. The cough was described as occurring throughout the day, but is most notable at night. She was evaluated by her primary care physician the previous day without provider concerns for intercurrent illness. The mother reported significant difficulties with oral feedings which have were also since device replacement and had timed periods of 5 minutes during which there are no difficulties followed by cough with or without emesis. The neurologist was informed of the issues from the treating nurse and agreed with the surgeon¿s recommendation for a period of rest for the vagus nerve. The vns output current and magnet current were both turned to 0 ma during the visit. The plan was to allow one week of vagal nerve rest. Later, notes dated (b)(6) 2013 report that the patient was admitted with a superficial vns wound infection with wound discharge. She was admitted for wound washout, exploration, and revision. Neurosurgery discharge notes dated (b)(6) 2013 indicate the patient was admitted with diagnosis of surgical wound dehiscence status post-vns replacement, with poor oral intake. The patient was discharged on (b)(6) 2013 with diagnosis of surgical wound dehiscence status post-vns replacement, left vocal cord paralysis, and poor oral intake. The hospital course notes indicate the patient had stimulator replacement on (b)(6) 2013 due to ¿vns malfunction,¿ as captured in manufacturer report number: 1644487-2013-01380. The patient presented to the clinic on (b)(6) 2013 with slight separation of the wound and small amount of white drainage for one day. The mother denied any fevers and seizures. The patient was having a lot of gagging and has not been tolerating any food intake. She lost a few pounds in the prior few days. An ent performed a laryngoscopic exam on the patient on (b)(6) 2013 which demonstrated paralyzed left vocal cord in the paramedian position with mild paryngomalacia. The patient was taken to the operating room on (b)(6) 2013 for a wound washout and revision. Her wound was only superficially dehisced and there was no purulent material seen. An ng tube was placed intraoperatively for nutritional supplemental. During the course of her hospitalization, speech therapy as well as a dietary consult was obtained. Serum electrolytes were monitored to ensure the patient did not develop any electrolyte imbalances from re feeding syndrome. Per speech therapy evaluation, the patient was to be continued on ng feeds. Intraoperative cultures of her wound were negative for bacterial growth. The plan was to complete a 7 day course of keflex. The patient¿s mother was instructed how to perform the ng tube feeds. At time of discharge, the patient was afebrile, voiding, tolerating her ng tube feeds, had good pain control and at her neurological baseline. The plan was for the patient to be admitted for long term monitoring which time speech therapy will be re-evaluating her swallowing function. Attempts for additional information are in progress but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3162932
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« Reply #22 on: November 16, 2017, 02:45:34 AM »

Model Number 304-20
Event Date 07/29/2014
Event Type Injury
Event Description
It was reported that the vns patient¿s neck incision site dehisced and exposed the lead on (b)(6) 2014. The patient underwent surgery on (b)(6) 2014 to close the incision site and no signs of infection were observed at the time. On (b)(6) 2014, the patient presented with a small amount of pus from the incision site and was subsequently treated with an antibiotic regiment. Cultures were positive for staph aureus. It was noted that the patient did not take proper care of her incision sites and was noncompliant in keeping her appointments. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported on 01/19/2015 that the patient¿s lead and generator were explanted on (b)(6) 2015 due to infection. The patient was not re-implanted at this time. The lead and generator were returned for analysis on 01/21/2015. Product analysis was completed for the lead on 02/09/2015. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Product analysis was completed and approved for the generator on 02/17/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 034 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

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=4353667
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« Reply #23 on: November 16, 2017, 02:46:20 AM »

Model Number 104
Event Date 03/01/2015
Event Type Injury
Event Description
It was reported that the vns patient presented with what appeared to be an infection over the generator site and was subsequently admitted to the er. Follow-up revealed that there was no infection; however, the generator incision site had thinned out and was on the verge of dehiscence. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4728661
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« Reply #24 on: November 18, 2017, 02:28:27 AM »

Event Date 03/25/2015
Event Type Injury
Event Description
It was reported on (b)(6) 2015 that the patient had the wound open up at the generator site. The patient¿s generator was recently replaced on (b)(6) 2015. The surgeon was planned to go in and clean the site and sew it back up on (b)(6) 2015. No known patient manipulation or trauma has occurred that is believed to have caused or contributed to the wound opening. The wound opening is not thought to be related to improper wound care from the (b)(6) 2015 surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4805314
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« Reply #25 on: November 18, 2017, 02:29:10 AM »

Model Number 103
Event Date 04/01/2015
Event Type Injury
Event Description
It was reported that the patient was seen on (b)(6) 2015 after picking the chest incision site causing wound dehiscence. The chest incision managed to heal once the dressing was changed and the wound was covered with antibiotics. The patient later picked at the neck incision and underwent full explant as a result. This is reported in manufacturer report # 1644487-2015-04804.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4803464
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« Reply #26 on: November 28, 2017, 02:36:56 AM »

Model Number 103
Device Problem No Information
Event Date 08/06/2015
Event Type Injury
Event Description
It was later reported on (b)(6) 2016 that the patient was scheduled to have her lead explanted that day due to an abscess in the neck area. Operative notes from (b)(6) 2016 report that the patient presented for ¿left cervical surgical skin site ulceration caused by erosion of underlying hardware¿ and plastic surgery for keloid formation around the previous generator site incision site. The indications for operation indicated that the generator was previously removed due to complication through the skin. Subsequently, that area of closure developed keloid and more an area in the center of the cervical incision site began to thin out and there was a palpable piece of hardware beneath that thinned out site. It worsened to the point skin broke through and there was a yellowish drainage that came from the site. This was cultured. The patient was admitted and was on iv antibiotics and brought to the room for the to remove the generator, the ulcerated and then have the plastic surgery service revise both the keloid incision and the lead incision on (b)(6) 2016. During the procedure, it was observed that the ulceration site was through dermis and through platysma. The area of the lead strain relief was eroding through the skin. Once that was excised out, the remaining tissues deeper appeared normal. It was irrigated with antibiotic irrigation and then the majority of lead was removed. For the remaining lead portion, it was assessed that it was not able to be easily extracted from within the carotid sheath. It was determined that this was unacceptably risky and difficult because of the extensive amount of scar tissue there/ what was at that point the only remaining wires with the thin final portions of the lead. It was felt that there was no deep infection. The deep space was verified to be sterile. The area was treated with the 3% hydrogen peroxide and after that irrigated it with bacitracin irrigation. The keloid at generator site was removed and there was additional debridement at the generator site. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.

Event Description
The patient later had generator explant surgery on (b)(6) 2015 due to an infected pocket. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.

Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital with an infection. The patient had pus around the generator site. The patient had surgery on (b)(6) 2015 due to the superficial wound infection in the chest. The procedure included debridement of the dermis and subcutaneous layer. The operative notes reported that the patient presented in clinic on (b)(6) 2015 with appearance of the incision overlying the vagus nerve stimulator generator with the appearance of thinning as though it was at risk of dehiscing. The next day, the patient was admitted with evidence dehiscence that had started to begun and there was also some superficial spreading redness, which had the appearance of cellulitis. Surgery was performed as an emergency procedure, and during the procedure, the site was debrided and irrigated. The surgeon concluded that the evidence was favorable to suggest that the infection was cellulitis only with skin edge dehiscence. The patient was then closed. The generator was not explanted. Good faith attempts for additional relevant information have been unsuccessful to date.

Event Description
Analysis was completed on the generator. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5111592
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« Reply #27 on: December 05, 2017, 01:52:26 AM »

Model Number 102
Device Problem Human-Device Interface Issue
Event Date 10/23/2015
Event Type Injury
Event Description
Additional information was received that the surgeon stated that everything appeared normal with the patient's implant after observing x-rays. The device had still not been turned on as of (b)(6) 2015. No additional relevant information has been obtained to date.

Manufacturer Narrative
(b)(4).

Event Description
It was reported via voicemail message from the patient that the patient had a newer model generator implanted but was "having a lot of trouble" and "does not feel comfortable with the way things turned out". Additional information was received that the patient had a dehiscence wound at the generator site from her replacement surgery (b)(6) 2015. Additional information was received that the patient did not believe the surgeon properly closed the incision. Additional information was received that the patient is being referred for generator/lead replacement due to pain in her neck where the lead is and when she moves her head to the left or looks up. Patient has also reported difficulty eating and chewing and states that she has lost weight since implant. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5250260
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« Reply #28 on: December 13, 2017, 02:29:33 AM »

Model Number 103
Device Problem No Information
Event Date 12/21/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2015 were received which indicated that on the morning of (b)(6) 2015 the patient's mother had concerns regarding the incision overlying the clavicle. When she was seen in clinic, it was noted that the midportion of this incision had dehisced slightly. Mom states that there has been some drainage. A decision was made to admit the patient for iv antibiotics with concerns that this was only a superficial infection and could, if not treated aggressively, track down and infected the hardware. She therefore was admitted and has been on iv clindamycin in the hospital since that time. The patient did quite well with her antibiotics and her wound improved significantly. There was no drainage since admission. The erythema, that had been surrounding nearly the entire incision, is essentially resolved. It was therefore felt that the patient was stable for discharge to home with oral antibiotics to complete at least a 2-week course. The parents were given instructions to wash this incision daily with soap and water at this point and to keep it dry and open to air as much as possible the remainder of the time. The patient was at a dosing appointment on (b)(6) 2015 and wound looked very good. Grandmother was at appointment and she stated the wound looks 100% better.

Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data; corrected data: inadvertently did not include the udi on the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5416989
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« Reply #29 on: December 13, 2017, 02:30:21 AM »

Model Number 106
Event Date 03/02/2016
Event Type Injury
Event Description
It was later reported by the physician that there was no infection at the site of the dehiscence. It was also explained that steri strips were put over the wound an held well, but the patient accidentally pulled the stari strips off, which allowed for the extrusion/dehiscence. Additionally, there were no issues with the device as the diagnostics showed the device was working as intended. The physician also clarified that the pain experienced by the patient was postsurgical pain and was not related to vns.

Manufacturer Narrative
(b)(4).

Event Description
It was reported by the patient that the area where her generator was implanted was still sore. The patient was instructed to call her physician. Later, the patient called back and stated her incision had opened up and she was having some yellow and green drainage from the site. At this point, she was once again instructed to contact her physician. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5532604
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