VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on November 15, 2017, 02:08:47 AM



Title: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 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


Title: Re: Dehiscence
Post by: dennis100 on December 13, 2017, 02:31:27 AM
Model Number 106
Event Date 02/23/2016
Event Type Death
Event Description
It was reported that a vns patient who recently had a generator replacement was scheduled to have their generator programmed on, but had a slight gap in the incision site. Tape was placed over the site and the patient was rescheduled to have it turned on at a later date. On the day that the patient was scheduled to visit the physician to have the device turned on, he was found dead in his bed. Follow-up by the company representative revealed that it was the neck incision that had opened and there was no presence of infection. The cause of death is unknown to-date. Additional relevant information has not been received to-date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5522718


Title: Re: Dehiscence
Post by: dennis100 on December 15, 2017, 01:56:36 AM
Model Number 106
Event Date 03/18/2016
Event Type Injury
Event Description
Per clinic notes received, both neck and chest incision nicely healed with no sign of infection.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's generator incision site had opened postoperatively and that the generator was visible. Patient went to ed and the physician closed the wound under sterile conditions with derma bond. Patient was discharged from the ed with 2 weeks worth of antibiotics. Patient did not report any discomfort but was able to see the generator. Patient was occasionally able to see yellow discharge from the wound. Patient is overall tolerating the stimulation well. No fevers or other signs of infection were present. The chest would was 90% healed with small dehiscence in the center of the wound, exposing the generator. Mild erythema to the wound edge was also present. Vns was interrogated and programmed to 2. 0mamp with no lead impedance noted. Due to infection, the patient later underwent generator was explanted on (b)(6) 2016. The explanted generator has not been received to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5621104


Title: Re: Dehiscence
Post by: dennis100 on December 16, 2017, 01:41:43 AM
Model Number 106
Event Date 03/15/2016
Event Type Injury
Event Description
It was reported on (b)(6) 2016 that the patient's wound has opened up. The vns was recently implanted on (b)(6) 2016. The wound opening was first noticed on (b)(6) 2016. It is believed that the child did a bear crawl when he was playing which may have caused the wound to open. The patient went to the er on (b)(6) 2016 because the site would not close. The physician closed up the site and it was stated that the site was infected and the patient was provided with some medication to remove the infection. The device was not explanted. The physician does not think that the device has the infection on it so he chose not to explant. They plan to monitor the patient.

Event Description
The design history record for the lead was reviewed and the device was hp sterilized prior to distribution into the field.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5563449


Title: Re: Dehiscence
Post by: dennis100 on December 16, 2017, 01:42:32 AM
Model Number 106
Event Date 03/04/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient had been picking at her incisions from her vns implant surgery. The incisions were slightly gaping as dehiscence wounds, and dermabond was applied to close the chest and neck incision sites. At the time of the initial report, the patient said that the incisions were healing and closed. There was no redness, oozing, or signs of infection at that time. Further information was received that the patient's neck incision was subsequently oozing pus, and the site was swollen red and painful. The symptoms began on (b)(6) 2016. The patient subsequently followed up with the surgeon's office for an appointment. She was treated with antibiotics to address a superficial infection. It was believed that the infection was also likely caused by patient influence at the surgical site. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5574698


Title: Re: Dehiscence
Post by: dennis100 on December 17, 2017, 02:09:04 AM
Model Number 105
Event Date 05/02/2016
Event Type Injury
Event Description
It was reported that the patient has drainage at the vns site. The patient was referred to the surgeon for evaluation. Review of device manufacturing records for the generator confirmed sterilization prior to distribution. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date. The patient had undergone generator replacement in (b)(6) 2015 due to wound dehiscence (mfr. Report # 1644487-2015-03969).

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5682344


Title: Re: Dehiscence
Post by: dennis100 on December 17, 2017, 02:09:43 AM
Model Number 106
Event Date 05/05/2016
Event Type Injury
Event Description
It was reported that the patient's generator incision was not healing well following replacement surgery and that the incision was open. The patient underwent an outpatient procedure where the incision was found to be small and superficial. No vns product was exposed. The incision was cleaned and sutured closed. Since the outpatient procedure the surgeon reports that the incision is healing well. Review of device manufacturing records for generator confirmed sterilization prior to distribution.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5682673


Title: Re: Dehiscence
Post by: dennis100 on December 17, 2017, 02:10:32 AM
Model Number 105
Event Date 04/12/2016
Event Type Injury
Event Description
It was initially reported that the patient's generator could be easily moved. At the time of the initial evaluation, the surgeon decided it was not medically necessary to proceed with surgery to address issues with the device migration. A non-absorbable suture was used to secure the generator at the time of the last generator replacement surgery. A subsequent report from the patient on (b)(6) 2016 indicated that she was actually proceeding with surgery. Further information indicated that there issues with seepage from the chest wound and device migration and protrusion. Follow up after her report indicated that her vns system was fully removed on suspicion of infection following a visit to the er and hospital admittance, and she was subsequently released from the hospital. Information received from the explanting surgeon's office confirmed that the patient's system was fully removed. The patient was admitted in-patient on (b)(6) 2016. The generator was reportedly extruding through a dehiscence wound. The generator was removed on a suspected infection in the chest. The lead was also removed to allow for full recovery, although there was no suspicion of infection in the neck. An antibiotic was prescribed. The pathology report for cultures showed negative or negligible for all tests, and showed no growth in culture media. The suture had to be cut for generator removal, indicating it was still intact before explant. No further information was given on potential causes or contributing factors to the device migration, protrusion, or extrusion. The explanting facility does not return explanted products per their internal policy, so return of the removed devices is not expected. The generator device history record was reviewed and found all specifications were met prior to distribution, and the generator was sterilized prior to distribution.

Manufacturer Narrative
(b)(4).

Event Description
Clinic notes were received with information on the patient's medical history. Some conditions were identified that may limit blood supply to certain regions of the body and contribute to wound healing difficulties. The surgeon did assess that he patient did not have risk factors for skin deterioration. However, his awareness of the patient's past medical history was uncertain. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5688800


Title: Re: Dehiscence
Post by: dennis100 on December 20, 2017, 08:26:11 AM
Model Number 105
Event Date 05/23/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a patient's incision site had opened up to where the generator was visible. The patient got into a fight and the stitches in the chest had come undone. The patient had generator replacement surgery on (b)(6) 2016. The physician elected to redo the patient's stitch. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5725773


Title: Re: Dehiscence
Post by: dennis100 on December 21, 2017, 02:38:12 AM
Model Number 106
Event Date 05/04/2016
Event Type Injury
Manufacturer Narrative
Suspect medical device udi: (b)(4).

Event Description
It was reported that the generator site was open and the generator was exposed. The patient was recently implanted on (b)(6) 2016. The patient was then referred for surgery to irrigate the site and close the incision. Further follow-up found that the patient has a history of picking at his skin during a seizure. The patient reported to the neurologist that he had a seizure and afterwards the generator incision was found to be open. The patient underwent surgery where the incision site was irrigated with antibiotic solution and the incision was closed. The generator was not replaced during this surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5718792


Title: Re: Dehiscence
Post by: dennis100 on December 22, 2017, 03:24:55 AM
Event Date 12/01/2010
Event Type Injury
Event Description
It was initially reported by the physician that the pt had an infection and was going to undergo surgery to have her vns generator replaced. Pt was hospitalized due to infection and it was informed that her incision site was opening up and they could see the generator. The surgeon plans to replace the generator and put the new generator in a new pocket. Good faith attempts to obtain additional info has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943813


Title: Re: Dehiscence
Post by: dennis100 on December 23, 2017, 01:58:40 AM
Model Number 103
Event Date 11/30/2011
Event Type Injury
Manufacturer Narrative

Event Description
A pediatric epilepsy nurse specialist in the united kingdom reported that they had a vns patient who has had ongoing problems with wound breakdown following vns surgery last (b)(6) (2011). A decision was made to explant the device. The patient has an extensive history of interventions taken to try to prevent the device being explanted and resolve their infection. Date the event 1st observed - was (b)(6) 2011. The patient was admitted to a children's ward with a chest infection. Discharged on (b)(6) 2011 with 1 week oral antibiotics. (b)(6) 2011 - neck wound inflamed (wound swab - scanty growth (b)(6)) treated with 7 days oral flucloxacillin. (b)(6) 2011- wound improving. (b)(6) 2011 - wound improving but not completely healed so continued on oral flucloxacillin. (b)(6) 2012 - wound not completely healed but no sign of infection. (b)(6) 2012 - debridement of neck wound - discharged on oral flucloxacillin. (b)(6) 2012 - neck wound clean; dry. (b)(6) 2012 - admitted to ward with infection in chest and neck wound - 3 weeks if iv antibiotics as an inpatient followed by 3 months oral antibiotics. (b)(6) 2012 - scab remained over neck wound - wire near surface. (b)(6) 2012 - neck wound explored and wire re-positioned. No evidence of infection. (b)(6) 2012 - wounds clean and dry - 3 months of oral antibiotics finished (b)(6) 2012 - area around chest wound appeared swollen but do evidence of infection or wound breakdown. (b)(6) 2012 - chest wound breakdown - no growth on wound swab. (b)(6) 2012 - wounds debrided and re-sutured. (b)(6) growth from tissue sent. Commenced iv antibiotics. (b)(6) 2012 - discharged home on once a day iv antibiotics by community nurses. (b)(6) 2012 - re-admitted with discomfort around chest wound, increased seizures and fluid collection under chest wound. (b)(6) 2012 - device and leads removed. Leads and tissue sent for flu culture - no growth after 48hrs. Continues in iv antibiotics. It was reported that the wound dehiscence and the infection were not related to the vns or the implant procedure although the patient's device was explanted related to the event. Patient manipulation or trauma did not occur that is believed to have caused/contributed to the wound dehiscence or the infection. No causal or contributory medication changes preceded the onset of the dehiscence or the infection. The infection was located at the neck wound. The neck location was re-explored in (b)(6) 2012 as electrodes were near the surface. The lead was re-positioned at this time.

Event Description
The explanted generator was returned for analysis. The lead was discarded. Completion of the generator analysis is pending.

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

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

Event Description
The patient's explanted generator was returned for analysis. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Additional information was received. That the patient's increase in seizures were above their pre-vns ratethe patient was given more anticonvulsant medication for the increased seizures. They were possibly due to the ongoing infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2777435


Title: Re: Dehiscence
Post by: dennis100 on December 26, 2017, 02:31:27 AM
Model Number 106
Event Date 07/15/2016
Event Type Injury
Event Description
Follow-up from the surgeon 10/14/2016 provided that the patient's incision opened right after the surgery due to the patient picking at it. The wound opening was superficial only and healed up after local care.

Event Description
It was reported by a vns patient's implanting physician that the patient's incision on his back had opened. It was noted that only the skin had opened and the generator looked covered. The physician said the intact skin was reinforced with steristrips. The local care for the wound would be provided by patient's parents. Additional relevant information has not been received to-date.

Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5870030


Title: Re: Dehiscence
Post by: dennis100 on December 29, 2017, 01:47:57 AM
Model Number 106
Event Date 06/26/2016
Event Type Injury
Event Description
The review of the manufacturing records confirmed the sterilization with (hp method) for the lead prior to the distribution. Further follow up indicated that the lead was not replaced.

Manufacturer Narrative

Event Description
It was reported that vns patient underwent a generator replacement. The reason mentioned on the implant card was "patient cut the incision". The lead impedance was ok after the replacement. The explanted generator was implanted on (b)(6) 2016. Further follow up indicated that the patient (mentally delayed) was implanted with the vns therapy since 2010 with positive outcome. He was admitted to the general hospital in the remote region on (b)(6) 2016, where they looked over the incision, they cleaned the wound, and stick dressing on the wound. While visiting the vns clinic as regular procedure to ramp up the device on (b)(6) 2016, they looked over the incision and found out the wound was open (patient was trying to remove out the device). The patient was admitted directly to the or for the next day on (b)(6) 2016 to clean and seal the wound. The neurosurgeon decided to replace the generator prophylactically; he cleaned the wound and changed the position of the generator in order not to have any infection. No explanted device is available to be returned to the manufacturer for analysis. The review of the manufacturing records confirmed the sterilization with (hp method) for the generator prior to the distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5942292


Title: Re: Dehiscence
Post by: dennis100 on December 30, 2017, 01:50:05 AM
Model Number 105
Event Date 07/01/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Product analysis was completed on the returned lead portion on (b)(6) 2016. Note that a portion of the lead body including the electrodes was not returned for analysis. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device. Product analysis was completed on the returned generator on (b)(6) 2016. Visual examination showed only explant-related observations; no surface abnormalities were noted on this device. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 074 volts and showed an ifi=no condition. Review of the internal device data showed no anomalies, with any noteworthy impedance changes occurring after the device explant. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the patient's generator site incision opened up. A revision surgery was planned, but the surgeon had assessed that the full vns system required removal. An infection was reportedly confirmed at that time, and the lead was extruding and in the infected area prior to removal. The explant procedure occurred on (b)(6) 2016. The explanted generator and lead were received for product analysis on 08/23/2016. Follow up with the surgeon's office showed that the patient's generator site opened in approximately (b)(6) 2016. Prior to the incident, the patient had developed a white bump over his generator site. His caregiver had scratched it off and caused bleeding, and the patient went to the er. Cellulitis and infection was suspected prior to the explant surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5925113


Title: Re: Dehiscence
Post by: dennis100 on December 31, 2017, 02:18:37 AM
Model Number 103
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported that the patient would not leave the site alone, so the wound would not heal properly. The physician stated that there was no relationship to the wound dehiscence and vns.

Event Description
It was reported that the patient¿s generator was explanted on (b)(6) 2014. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. Analysis showed that the pulse generator performed as expected and no adverse conditions were found with the device. Further follow-up revealed that the device was explanted due to multiple episodes of wound dehiscence. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4440927


Title: Re: Dehiscence
Post by: dennis100 on December 31, 2017, 02:19:34 AM
Model Number 106
Event Date 09/27/2016
Event Type Injury
Event Description
It was reported that the patient had presented with a dehiscence wound several months after the device had been explanted due to infection. The wound had not completely healed and he was placing vaseline on the wound. No additional relevant information has been received to date.

Event Description
It was reported that the patient was having his vns generator explanted due to infection. Further follow-up found that the patient presented with purulent drainage at the generator site. The patient underwent a wound cleaning procedure for the infection however the surgeon then elected to remove the generator. The lead was cut and the portion of the lead with the electrodes was left implanted. Samples from the infection were sent to the microbiology lab however the results from the microbiology testing have not been received to date. Manufacturing records for the generator were reviewed and it was noted that it was sterilized prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Corrected data: evaluation codes: this information was inadvertently reported incorrectly on mfg. Report 0.

Manufacturer Narrative
Suspect medical device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6053715


Title: Re: Dehiscence
Post by: dennis100 on December 31, 2017, 02:20:47 AM
Model Number 106
Event Date 09/17/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient picked at his previous generator site and caused the surgical scar to experience dehiscence and minor bleeding. The patient visited the emergency room, and the wound was addressed by being re-sutured. The patient's treating physician believes that the patient's manipulation of the would caused the dehiscence and bleeding. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6028328


Title: Re: Dehiscence
Post by: dennis100 on January 01, 2018, 02:23:46 AM
Model Number 105
Event Date 10/13/2016
Event Type Injury
Event Description
The explanted generator and lead were received by the manufacturer for analysis. Product analysis is expected; however, it has not been completed to date.

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

Manufacturer Narrative
(b)(4).

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6055616


Title: Re: Dehiscence
Post by: dennis100 on January 01, 2018, 02:24:43 AM
Model Number 103
Event Date 12/12/2011
Event Type Injury
Event Description
Additional information was received that the patient may have their vns device reimplanted in the future. No surgery date is set at this time.

Event Description
Additional information was received that the patient would go to surgery (b)(6) to have their generator reimplanted. Since their explant the patient has been having multiple daily seizures, she is very difficult to take care of and can be very aggressive. The infection was a (b)(6) and they were treated with antibiotics for approximately 2 weeks.

Manufacturer Narrative

Event Description
Additional information was received about the patient's vns explant surgery. It was reported that the patient had recently had a vns instillation that went very well, she actually had fewer seizures. Her seizures changed in character. With vns they were shorter and less severe and also the power of having the magnet to swipe and stop a seizure. Unfortunately, there was a (b)(6) infection and vns had to be removed. Three days prior to their removal of their vns generator and wound washout their mother noticed that her daughter was having trouble swallowing, and then during a coughing fit, broke open her neck incision and purulent discharge poured forth in a large volume. The patient was brought to clinic and was admitted to the hospital and scheduled for operative removal and washout of her wounds. Since explant the patient continues to have seizures the same as she had previously and her review is again consistent with extremely low functioning. The patient's mother is going to have a consult planned in the future for reimplant of their device.

Manufacturer Narrative
Suspected medical device operator of device corrected data; updated to patient. Corrected data: surgery was (b)(6) 2012. A 30 day report omitted of initial report.

Event Description
It was reported that the patient's incision site looked raised, but was not red per physician. The patient had the vns device removed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414468


Title: Re: Dehiscence
Post by: dennis100 on January 02, 2018, 02:20:54 AM
Model Number 106
Event Date 08/10/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was scheduled for surgery to reposition, the vns generator in a different location. The reason for the repositioning surgery was not immediately known. Further follow-up found that the patient presented with an infection after a recent generator replacement surgery. Review of the manufacturing records confirmed that the generator was sterilized and passed quality control inspection prior to distribution. The generator was repositioned during a surgery on (b)(6) 2016 where it was kept in the left chest however it was moved to a new location. After being repositioned, a diagnostic test found an impedance value the within acceptable range. No additional relevant information has been received to date.

Event Description
It was reported that following the repositioning surgery the patient developed a dehiscence wound which required additionally surgery to close the wound. At the time of the report the dehiscence wound did not appear to be related to the original infection therefore the dehiscence wound event was reported in mfg report #1644487-2017-03189. It was later reported that fluid then began to build in the pocket and the patient was again referred to surgery to drain the pocket and explant the generator. During the surgery fluid was observed inside the lead. The surgeon was concerned that the fluid leaks in the lead could have been a contributing factor for the infection issues that were previously reported in this report and in mfg report #1644487-2017-03189. The fluid leaks in the lead and dehiscence wound events are being reported in mfg report #1644487-2017-03189. While this report will only capture the initial infection that occurred after the generator replacement surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6113549


Title: Re: Dehiscence
Post by: dennis100 on January 02, 2018, 02:21:45 AM
Model Number 106
Event Date 07/26/2016
Event Type Injury
Event Description
It was reported that the patient underwent generator explant surgery. No additional relevant information has been received to date.

Manufacturer Narrative
Suspect medical device udi: (b)(4).

Event Description
It was reported that the following generator replacement surgery the patient presented with a dehiscence wound at the generator incision site. The surgeon denied the presence of an infection. The surgeon believed the dehiscent wound was related to the generator replacement surgery. The manufacturing records of the generator were reviewed and it was observed that the generator was sterilized and passed qc inspection prior to distribution. The generator was turned off and the patient was later referred for generator explant surgery. However no surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6100938


Title: Re: Dehiscence
Post by: dennis100 on January 03, 2018, 02:09:50 AM
Model Number 102R
Event Date 11/01/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's generator wound incision had opened was found to be approximately 0. 5 cm and after a week it continued getting larger with clean edges. There is no sign of infection but the patient was placed on a prophylactic antibiotics. The open wound was covered with a sterile dressing. The patient was evaluated by the surgeon who decided to refer the patient for surgery to replace the generator and close the open wound. The surgeon noted that there was erosion over the area of the generator and the generator was exposed. Neither the neurologist or surgeon could determine why the incision opened. Manufacturing records of the generator showed that the generator was sterilized prior to distribution. The patient underwent generator replacement surgery. Diagnostic testing was reportedly performed a week prior to the surgery and the results were within the acceptable range. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6158915


Title: Re: Dehiscence
Post by: dennis100 on January 03, 2018, 02:10:52 AM
Model Number 106
Event Date 09/19/2016
Event Type Injury
Manufacturer Narrative
Date of event, corrected data: supplemental mdr #1 inadvertently reported an inaccurate event date. The infection likely began prior to when the physician first noticed it in clinic. Therefore the date of implant is a more appropriate event date. Describe event or problem, corrected data: initial and supplemental #1 mdr inadvertently left off the increase in seizures the patient experienced following a settings change. Relevant tests/laboratory data, including dates, corrected data: initial and supplemental #1 mdr inadvertently left off the settings from (b)(6) 2016.

Event Description
Information was received which indicates that the patient had their generator explanted due to an infection that was believed to have been caused by either the patient picking at the incision site or drooling on the incision site. The patient was then explanted and the leads were cut. The device history record was reviewed for both the patient's lead and generator. The generator was sterilized prior to leaving the facility and had a sterilization expiration date of 03/22/2018. The lead was sterilized prior to leaving the facility and had a sterilization expiration date of 10/01/2004. The explanted devices were disposed of by the explanting facility. No return is expected. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

Event Description
The patient's caretaker reported that the patient experienced an increase in seizures following a settings change on (b)(6) 2016. The seizure log with the neurologist indicated that the patient had one 2 minute seizure on (b)(6) 2016. The patient's settings were then adjusted on (b)(6) 2016. Shortly after the patient became ill which may have contributed to the increase in seizures.

Event Description
Information was received from the physician indicating that the patient presented on (b)(6) 2016 with infection and dehiscence wound. The patient's generator was subsequently removed on the same day. No other relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6175461


Title: Re: Dehiscence
Post by: dennis100 on January 03, 2018, 02:11:41 AM
Model Number 106
Event Date 09/24/2016
Event Type Injury
Event Description
It was reported that the patient presented to the er with wound healing issues following recent generator replacement surgery. The patient was evaluated by the surgeon and it was noted that the corner of the generator was exposed. The wound dressings were changed and the patient was prophylactically prescribed antibiotics. The patient was referred for would flap surgery. At a follow-up appointment on (b)(6) 2016, it was noted that the would was healing and was about the size of a dime. Additionally, the generator was no longer exposed. The patient was once gain prophylactically prescribed antibiotics and given additional wound supplies to continue dressing the wound. A few weeks later, the patient's care home reported that the patient had been "horsing around with a friend" which caused the wound to open again and the generator was exposed. When the patient was evaluated by the surgeon on (b)(6) 2016, the generator and lead were out of the pocket. It was noted that the lead was broken. The surgeon then explanted the lead and generator in the office and the explanted products were given to the patient's caregivers. The wound flap surgery was then canceled. A review of manufacturing records showed that the generator was sterilized prior to distribution.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6117942


Title: Re: Dehiscence
Post by: dennis100 on January 05, 2018, 03:36:51 AM
Model Number 102R
Device Problem No Known Device Problem
Event Date 01/24/2017
Event Type Injury
Event Description
A call was received from the hospital requesting a product return number as the patient had undergone vns generator and lead explant due to wound dehiscence. The patient had been admitted to the er a few days prior to the explant surgery due to an unrelated issue, and the physician reported to the surgeon that he was able to see the generator through the patient's incision. It was confirmed there was no sign or suspicion of infection. Review of the dhr for the generator confirmed sterilization prior to distribution.

Manufacturer Narrative

Event Description
Product analysis (pa) for the returned generator was completed. The reported ¿extrusion/generator¿ allegation is beyond the scope of the activities performed in the pa laboratory. During analysis, it was found that the device performed according to functional specifications and concluded that no abnormal performance, or any other types of adverse conditions, was found. It was later reported by the physician's office that they believe the patient had picked at the incision, which caused the extrusion. Pa for the returned lead was completed. The allegation of extrusion is not an actionable issue which will result in confirmation of an event and identification of a casual factor in the pa laboratory environment. Note that the lead assembly, including the electrode section, was not returned for analysis and thus 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. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6341897


Title: Re: Dehiscence
Post by: dennis100 on January 06, 2018, 03:38:02 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 01/31/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient needs to have her vns replaced because her pocket incision had opened and the site was infected. Follow-up to the physician provided that the wound had healed fully post-surgery. He thought the wound opened because the carehome physically lifts the patient on a regular basis. He believed the way they were lifting her caused the device to wear away the skin at the incision site, causing it to open and become infected. Review of manufacturing records provided the devices were sterilized prior to distribution. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6356632


Title: Re: Dehiscence
Post by: dennis100 on January 07, 2018, 03:23:19 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 09/02/2016
Event Type Injury
Manufacturer Narrative

Event Description
A report was received indicating that an abscess or blister had developed on the patient's chest incision. The reported indicated that the abscess was not leaking but appeared filled with pus and indicated that the wound appeared dehisced. It was unclear what caused the abscess/blister to form. The patient then sought treatment at an er when the abscess/ blister ruptured. The patient was prescribed antibiotics to treat the infection that was found when the abscess/ blister ruptured. The antibiotics reportedly cleared the infection. The device history record for both the generator and lead were reviewed. It was found that both devices had been 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=6232562


Title: Re: Dehiscence
Post by: dennis100 on January 08, 2018, 02:23:18 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 04/01/2006
Event Type Injury
Event Description
It was reported that the patient's vns was explanted two weeks after implant surgery due to infection. It is unclear if the lead and/or the generator was explanted. The manufacturer's device history records of the generator and lead were reviewed and sterilization was confirmed. No further relevant information has been received to date.

Event Description
Operative notes were received that described the patient's explant and wound debridement due to infection. The operating notes indicated that the patient had an eschar over the generator site that opened, revealing the generator itself. For this reason, the site was believed to be infected. The patient was not considered to be septic, toxic, or febrile on exam. It was indicated that the infection was localized to the subcutaneous tissue. The patient's full lead (including electrodes) and generator were explanted. The patient's eschar was removed. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6350406


Title: Re: Dehiscence
Post by: dennis100 on January 10, 2018, 01:39:18 AM
Model Number 102
Event Date 12/02/2008
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
Reporter indicated a vns patient had poor wound healing and developed an infection and wound dehiscence at the vns generator and electrode incision sites. The patient's poor wound healing and wound dehiscence are attributed to patient trauma of picking at the incisions, poor hygiene, and possibly coumadin medication. The patient later underwent explant of the vns generator only. The explanted generator has been returned and is currently in product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1381549


Title: Re: Dehiscence
Post by: dennis100 on January 10, 2018, 01:40:04 AM
Model Number 103
Event Date 04/23/2009
Event Type Injury
Manufacturer Narrative
See scanned page.

Event Description
It was reported that a vns pt reopened his chest incision site during a seizure and that the device became visible through the open wound. The pt's implanting surgeon indicated that several medications were administered to the pt to address the wound dehiscence, and that the event eventually led to device explantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1380341


Title: Re: Dehiscence
Post by: dennis100 on January 11, 2018, 02:01:06 AM
Model Number 102
Event Date 05/28/2009
Event Type Injury
Event Description
The reporter indicated that a vns patient developed a dehiscence chest wound after having a seizure in the middle of the night, eight days after generator revision surgery. The patient's implanting surgeon indicated that the wound was re-stitched and that bactracin was administered without further issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1419364


Title: Re: Dehiscence
Post by: dennis100 on January 11, 2018, 02:01:50 AM
Model Number 102R
Event Date 06/20/2009
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

Event Description
Reporter indicated a vns patient's generator and lead were explanted due to infection and wound dehiscence at the generator site. The infection was due to the patient manipulation and possible body positioning; the patient sits with her head tilted forward and to the left. Rare diptheroids were noted in the wound culture results. The patient is recovering from the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1417872


Title: Re: Dehiscence
Post by: dennis100 on January 12, 2018, 01:49:22 AM
Model Number 103
Event Date 04/26/2009
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a recently implanted vns patient developed a small area of wound dehiscence at the vns generator site. No evidence of infection was noted. No other information was given by the reporter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1392488


Title: Re: Dehiscence
Post by: dennis100 on January 12, 2018, 01:50:06 AM
Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that a vns patient developed multiple dehiscence chest wounds as a result of patient device manipulation. The patient's generator was eventually moved to the midline of the patient's chest and later the device began to extrude from the patient's skin as a result of continued manipulation and weight lifting. The patient's implanting surgeon explained that weight lifting was a suspected contributing factor as the patient allowed the bench press bar to hit his chest between reps. These events led to the eventual explantation of the patient's generator, though the patient's lead was allowed to remain implanted. The explanted generator was returned to the manufacturer and an analysis of the device confirmed proper device function. Additional information was received from the patient's implanting surgeon, who indicated that the patient's lead had begun to extrude through a small hole in the skin of the patient's chest and added that the contaminated ends had fostered the development of an abscess/infection with colitis in this area. The surgeon indicated that the event was once again likely related to patient manipulation and that a majority of the lead was surgically removed through the small hole in the patient's chest, adding that the remainder of the device would be removed if additional issues developed. The surgeon also stated that the patient's abscess was drained and treated with antibiotics and "is currently healing quite well" manufacturer's report # 1644487-2009-01810 will reference the product information of the patient's lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1455916


Title: Re: Dehiscence
Post by: dennis100 on January 15, 2018, 02:07:47 AM
Event Date 01/01/1998
Event Type Injury
Event Description
It was reported in a review of a journal article titled vagus nerve stimulator implantation in children, that one patient experienced traumatic dehiscence of the chest wound secondary to wrestling 9 days after implantation. A small hematoma near the generator was drained at the bedside through the small wound dehiscence. There was no sign of infection. Antibiotics were administered for 48 hours. The patient was discharged while maintaining oral antibiotic therapy until the wound closed secondarily. No signs of infection had become present 8 months following the injury.

Manufacturer Narrative
Article citation: kirse, d. , werle, a. , murphy, j. , eyen, t. , bruegger, d. , hornig, g. , torkelson, r. "vagus nerve stimulator implantation in children. " archives of otolaryngology - head and neck surgery vol. 128 (nov 2002). 1263-1268.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1541695


Title: Re: Dehiscence
Post by: dennis100 on January 15, 2018, 02:08:28 AM
Model Number 103
Event Date 10/19/2009
Event Type Injury
Event Description
Reporter indicated a patient developed a superficial infection and wound dehiscence at the vns generator incision site and was hospitalized for five days. The patient received intravenous vancomycin and oral antibiotics. The causative organism was possibly coagulase negative staphylococcus aureus. The patient has finally recovered from the infection. The cause of the infection is unknown per the reporter.

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=1532686


Title: Re: Dehiscence
Post by: dennis100 on January 15, 2018, 02:09:10 AM
Model Number 102
Event Date 01/26/2010
Event Type Injury
Manufacturer Narrative
Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a vns pt developed wound dehiscence and infection at his generator site caused by repeatedly picking at the incision site. The generator was explanted and the pt was placed on antibiotics. The pt is recovering and will likely be reimplanted with a new generator in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1615210


Title: Re: Dehiscence
Post by: dennis100 on January 15, 2018, 02:09:57 AM
Model Number 102R
Event Date 09/01/2009
Event Type Injury
Event Description
It was indicated by the surgeon that pt had an explant surgery due to "wound dehiscence-infection. " explanted products were discarded, so will not be returned. Pt was not re-implanted that time. Device sterility records were checked and it was confirmed that the device was sterile at the time of dispatch from the manufacture. Follow up with the surgeon's nurse revealed that infection was related to the implant surgery. Cultures were taken, but she does not remember what they were. No pt manipulation or trauma was reported. Pt's body did not take the surgery very well; therefore, developed an infection at the generator site.

Manufacturer Narrative
Device manufacturing records were reviewed. Results: 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=1527014


Title: Re: Dehiscence
Post by: dennis100 on January 16, 2018, 05:09:18 AM
Model Number 103
Event Date 01/14/2010
Event Type Injury
Event Description
Reporter indicated a patient developed wound dehiscence at the vns generator site in the chest and at the vns lead electrode site in the neck two days after initial implant surgery. An actual infection was not reported. The patient was hospitalized and received intravenous antibiotics and wound packing, followed by exploratory surgery of the chest and neck wounds, with reclosure of the surgical wounds. The reporter stated the patient was sensitive to the absorbable sutures used in the initial surgery, which caused the wound dehiscence. The wounds were reclosed with nylon sutures. At the patient's follow-up visit, the wounds were healing well with no signs of infection and the nylon wound closure sutures were removed.

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=1599288


Title: Re: Dehiscence
Post by: dennis100 on January 17, 2018, 03:42:36 AM
Model Number 302-20
Event Date 01/26/2010
Event Type Injury
Event Description
It was reported that the patient was last seen on (b) (6) 2010 for follow up on the implant surgery. The patient was given some derma bond because she was picking at her incision on the neck, causing some wound dehiscence. There was no exposure of the device or infection. The patient has subsequently been followed by the treating neurologist, which doesn't have any noted issued on the patient's wounds. No further details were made available on the issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1647354


Title: Re: Dehiscence
Post by: dennis100 on January 19, 2018, 02:47:31 AM
Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was initially reported that the pt was experiencing an infection at the generator site following the replacement of the generator. It was noted that the nurses at the pt's group home noted redness and infection signs at the operation site on pt's chest. There was also mention of wound dehiscence, which was later resolved. The pt's generator was then removed and treated with vancomycin due to the confirmed presence of (b) (6). There was no known pt manipulation. The pt is expected to have his device replaced. No further details have been made on the event.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1631441


Title: Re: Dehiscence
Post by: dennis100 on January 22, 2018, 01:45:11 AM
Model Number 102
Event Date 05/01/2010
Event Type Injury
Event Description
It was initially reported by the surgeon that the patient fell down and had his incision site re-opened. Patient had a battery replacement surgery due to end of service recently. No additional information was received. The fall most likely caused the incision site to re-open. Patient was taken to er and had his device replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726373


Title: Re: Dehiscence
Post by: dennis100 on January 25, 2018, 02:35:32 AM
Model Number 102
Event Date 09/20/2007
Event Type Injury
Event Description
Reported indicated that after initial vns implant surgery on (b)(6) 2007, the incision site "opened up almost all the way" and that she had "a superficial infection" due to the "surgical glue" used on her incision. Attempts to the implanting surgeon for additional information have been unsuccessful to date.

Manufacturer Narrative
Method - device manufacturing records were reviewed. Results - 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=1805148


Title: Re: Dehiscence
Post by: dennis100 on January 28, 2018, 01:59:51 AM
Model Number 102
Event Date 06/25/2010
Event Type Injury
Event Description
Reporter indicated a vns pt who is developmentally delayed picked at the generator site incision one week after generator replacement surgery and developed wound dehiscence. The wound was cleaned and re-stitched; after one month, the pt developed wound dehiscence again and an infection at the generator site. Pt manipulation of the incision site was not believed to be a cause of the infection the second time the wound underwent dehiscence. The reporter indicated the infection and wound dehiscence are due to the vns. Explant of the vns generator appears likely. Further attempts for information are in progress.

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=1870802


Title: Re: Dehiscence
Post by: dennis100 on January 28, 2018, 02:00:52 AM
Event Date 09/09/2010
Event Type Injury
Event Description
Reporter indicated a vns pt's generator site wound had dehiscence and was causing pain, and required additional surgery to close the incision site. F/u with the reporter revealed the dehiscence and pain were due to the suture being placed incorrectly under the pt's skin, and not to the vns device itself. The pain resolved after the incision site was re-sutured. Attempts for vns implant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1869525


Title: Re: Dehiscence
Post by: dennis100 on January 29, 2018, 01:44:11 AM
Model Number 103
Event Date 10/01/2010
Event Type Injury
Event Description
It was initially reported by the patient's caregiver that the patient was recently implanted with a vns device and was taken into surgery again as her incision site opened up. Patient was taken to the surgeon and infection was noted. There was a clear, yellow liquid leaking out of her generator pocket. The surgeon cleaned the incision site and taped it up. Add'l info was received from the caregiver stating that the patient was taken into a second surgery as the incision site opened up again. Good faith attempts to obtain add'l info has been unsuccessful til date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910672


Title: Re: Dehiscence
Post by: dennis100 on January 30, 2018, 02:15:40 AM
Model Number 103
Event Date 09/21/2010
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
A vns surgeon's office reported to our country representative in (b)(6) that they had a vns pt who developed a postoperative infection at the generator incision site with wound dehiscence and had their vns generator explanted. The pt's infection is being attributed to their implantation of the vns. No pt trauma or manipulation of their vns site was reported prior to their infection. Their infection has since resolved and the pt will be getting another implantation of the vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1905623


Title: Re: Dehiscence
Post by: dennis100 on January 30, 2018, 02:16:27 AM
Model Number 103
Event Date 10/01/2010
Event Type Injury
Event Description
It was initially reported by the surgeon that the pt was going to have a new generator placed soon as the last one was removed due to infection. The surgeon wanted to wait until infection cleared up before replacing. Surgeon notes stated that the pt had a wound dehiscence a few weeks after he had his vns battery replacement surgery. Good faith attempts to obtain additional information has been unsuccessful till date.

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=1943814


Title: Re: Dehiscence
Post by: dennis100 on January 31, 2018, 01:44:13 AM
Model Number 106
Event Date 06/13/2016
Event Type Injury
Event Description
It was reported that a patient's wound did not properly heal after her generator replacement surgery on (b)(6) 2016. The patient had two visits to the emergency room and underwent antibiotic treatment, but the wound opened and the generator was visible. The patient's device was then explanted. The device history records of both the generator and lead were reviewed, and the devices were sterilized according to procedure prior to release. The operative report was received from the explanting facility. The patient's wound swelled over the course of a few days and dehisced. The patient was admitted to the intensive care unit and had the generator and most of the lead explanted on (b)(6) 2016 so antibiotics could treat the infection. A suture granuloma was removed from where the generator was placed, and there was an area above the incision of necrotic tissue that was removed as well. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5835493


Title: Re: Dehiscence
Post by: dennis100 on February 01, 2018, 03:55:01 AM
Model Number 302-20
Event Date 08/01/2010
Event Type Injury
Manufacturer Narrative
Device history records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient's neck wound from vns implant had been experiencing drainage for approx four months and the wound was getting larger. It was indicated that there was granulation tissue at the medial aspect of the wound that was cauterized using silver nitrate. A portion of the lead was visible within the granulation. The physician also prescribed bacitracin to treat the wound dehiscence. It was later found that the wound was likely a stitch abscess. This was removed and the wound was cleaned. The vns lead was not removed. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993841


Title: Re: Dehiscence
Post by: dennis100 on February 01, 2018, 03:55:38 AM
Event Date 12/22/2010
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
It was initially reported by a nurse that a vns pt had a wound infection and dehiscence with the lead extruding at the superior portion of the chest wall incision. The pt was scheduled to see the neurosurgeon to have his generator and lead removed. Additional info was received from the nurse indicating that at the moment the cause of the reported wound infection and dehiscence with the lead extruding at the superior portion of the chest wall incision was unk. The nurse indicated that the lead and generator were removed on (b)(6) 2011 and cultures were taken, but no growth was seen in 48 hours. Further plans are to have the pt re-implanted in the next month. Good faith attempts to obtain product info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1987529


Title: Re: Dehiscence
Post by: dennis100 on February 04, 2018, 02:09:20 AM
Model Number 103
Event Date 03/07/2011
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the vns patient had his lead and generator explanted due to infection at the generator site. Cultures had been taken on (b)(6) 2011 that indicated (b)(6). No trauma or manipulation was reported. The surgeon's office stated that the wound had dehisced and the generator could be seen inside the wound. No medication changes were made precluding the wound dehiscence. The patient is currently reported as healing well. Review of the device history record confirmed sterility of the lead and generator prior to being shipped from the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2077810


Title: Re: Dehiscence
Post by: dennis100 on February 06, 2018, 02:15:30 AM
Model Number 302-20
Event Date 04/19/2011
Event Type Injury
Event Description
Reporter indicated a patient was to have possible scar revision surgery at the vns lead incision site in the neck due to possible scar tissue encasing the lead and causing neck pain with movement. The patient previously had wound dehiscence at the neck incision in (b)(6) 2011. Surgery is tentatively planned for (b)(6) 2011.

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 a vns pt has a wound dehiscence "dimple" at the electrode site incision in the neck. No drainage or infection was present, and no hardware was visible in the wound. The pt had no trauma and did not manipulate the vns. The pt was placed on keflex antibiotics along with topical bacitracin antibiotic. The pt was seen again on (b)(6) 2011 and is stable; "no better, no worse. " topical bacitracin treatment is to continue, and the pt has been referred back to the care of his neurologist. The cause of the wound dehiscence is unk.

Event Description
Reporter indicated, the patient had lead repositioning surgery performed on (b)(6) 2011. Diagnostics were within normal limits and the vns generator was reprogrammed to intended settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2100482


Title: Re: Dehiscence
Post by: dennis100 on February 06, 2018, 02:17:41 AM
Model Number 102R
Event Date 04/14/2011
Event Type Injury
Event Description
Reporter indicated the patient developed seromas in the chest and neck that later developed into abscesses, which is why the patient's vns was explanted. The events are felt to be related to trauma to the arms and neck by the patient's attendants while repeatedly moving the patient. The patient is recovering satisfactorily from the explant surgery. Analysis of the explanted vns generator was completed. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator shows no evidence of bodily fluid remnants in the case/header areas. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

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

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

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

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

Manufacturer Narrative
(b)(4).

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098698


Title: Re: Dehiscence
Post by: dennis100 on February 06, 2018, 02:19:00 AM
Event Date 04/21/2011
Event Type Malfunction
Event Description
It was reported via poster presentation entitled "vagus nerve stimulator in a pediatric population-surgical technique considerations in young children" that one pt underwent revision surgery due to dehiscence wound and possible mechanical problems. No further details given and attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102364


Title: Re: Dehiscence
Post by: dennis100 on February 07, 2018, 03:12:45 AM
Model Number 103
Event Date 05/11/2011
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a vns pt developed wound dehiscence at the vns generator site. The pt's vns is implanted in his back. The wound dehiscence was caused by the pt contorting himself during a seizure shortly after initial vns implant surgery and the wound opened up. The wound later developed an infection and the generator only was explanted; the vns lead remains intact in the pt. No pt manipulation of the wound occurred. The pt is currently on antibiotics. The pt is having daily wound care involving wound irrigation and wet-to-dry dressing changes. The incision is healing and the pt is doing well. The plan of care is to reimplant a new vns generator when the pt has fully healed. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129949


Title: Re: Dehiscence
Post by: dennis100 on February 08, 2018, 01:52:40 AM
Model Number 303-20
Event Date 06/01/2011
Event Type Injury
Event Description
It was reported that the pt incision on his neck had opened due to his helmet strap rubbing on it and the lead was visible through the opening. The pt had surgery to close the incision.

Event Description
Additional information was received that the patient had another surgery due to the lead extrusion. The surgeon opened the incision site and positioned the lead so that it was no longer extruding from the neck. The surgeon will explant the patient if this occurs again. The surgeon still believes this is due to the patient's helmet rubbing against the neck. There was no infection present and diagnostics before and after the procedure with within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180950


Title: Re: Dehiscence
Post by: dennis100 on February 09, 2018, 03:00:23 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 08/29/2008
Event Type Injury
Event Description
It was reported that the patient's device had been explanted several years ago due to an infection. Further follow-up found that the infection first presented following the initial implant of the device and the patient was treated with antibiotics. A dehiscence wound developed at the lower part of the incision due to a retained suture. Then several years later a blister developed at the same site which eventually began to dehisce and drain. This lead to an infected generator pocket. The generator and partial lead were then explanted due to this infection. A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7233112


Title: Re: Dehiscence
Post by: dennis100 on February 09, 2018, 11:28:08 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 12/21/2017
Event Type Injury
Event Description
It was reported that the patient was to have her vns generator and the generator pocket washed out with the leads remaining implanted. The company representative reported that at the initial post-op follow up appointment for the implantation surgery, the patient appeared to exhibit flu-like symptoms and the surgeon thought it was not an infection at the time. It was reported that standard protocol post-surgery antibiotics were given following the surgery. The patient reported getting infections in the past from past surgeries, which were not vns surgeries. The patient underwent vns generator explant surgery. The patient later provided a detailed timeline of the events. At the post-op follow up, there was redness at the neck incision. The following day, the patient awoke to pain and a lump on the neck. The pain increased over the day and the incision opened with a purulent discharge. The patient went to the er and received iv antibiotics. The surgeon saw the patient at the hospital the next day and the patient was discharged with oral antibiotics. On the next follow up, the patient felt that the neck incision appeared better. However, the generator incision was red and appeared to have an infection. Cultures indicated both aerobic and anaerobic bacteria. The patient stated that she always had a propensity to infections following surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation was not necessary because the reported event has been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7198988


Title: Re: Dehiscence
Post by: dennis100 on February 12, 2018, 01:42:09 AM
Model Number 103
Event Date 08/08/2011
Event Type Injury
Event Description
It was reported that the pt's wound was not healing and had opened. The pt was admitted to the hospital as a result and had her vns generator explanted. Review of the device history record confirms sterilization of the generator prior to distribution. Attempts for further 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246587


Title: Re: Dehiscence
Post by: dennis100 on February 14, 2018, 01:38:51 AM
Model Number 103
Event Date 10/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
The patient's implant information was received and has been included in this report.

Event Description
It was initially reported that a vns patient implanted in (b)(6) 2011 had to have the lead and generator removed due to pocket erosion. The surgeon indicated it looked as though someone had cut the stitches and the wound opened up; therefore, the lead and generator were removed on (b)(6) 2011. Additional information received revealed that there was no infection. The patient was able to see the vicryl suture at the edge of the generator (used to secure the generator to the fascia) and the patient cut the suture off which is believed to have resulted in the surgical wound opening up and separating. There was no frank evidence of infection when the incisions were opened and the lead and generator were removed. The neck incision was then closed once the lead was removed. The generator site was packed with triple-antibiotic soaked nu gauge. The patient did was admitted on (b)(6) 2011 and discharged on (b)(6) 2011. No further information has been provided at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2297702


Title: Re: Dehiscence
Post by: dennis100 on February 14, 2018, 01:39:41 AM
Model Number 102
Event Date 09/05/2011
Event Type Injury
Event Description
Further information from physician reveals that the infection was believed to be due to vns, but patient manipulation or trauma occurred "immediately post op" that may have contributed to the infection. No cultures of the would were taken. The patient was put on antibiotics and the issue resolved.

Event Description
It was reported that one week after the vns implanted surgery, the pt had redness and swelling at the generator site. He tried cleaning the wound, and on the day he was supposed to go for a follow-up visit with his neurologist, it appeared that the wound was opening up. On the same day, the physician referred the pt back to the surgeon. The pt was put on antibiotics. The pt explains that he saw the surgeon and was told the infection is getting better, and the pt can return to "light" or "limited" work. Attempts for further information have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2307851


Title: Re: Dehiscence
Post by: dennis100 on February 14, 2018, 01:40:41 AM
Model Number 102R
Event Date 07/19/2011
Event Type Injury
Event Description
Additional information was received regarding the patient. The patient had a fall on (b)(6) 2011. The patient fell on his generator and small lesion that dehisced slightly. The notes then went on to state that there was no open area. No infection was mentioned.

Event Description
Additional information was received that the patient was re-implanted after their explant due to an infection.

Event Description
Product analysis was completed on the generator and lead. 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 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 portions 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 pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the device. Note that since the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
It was initially reported that the patient had their generator and lead explanted due to an open wound and infection. The patient had fallen and the skin around the generator opened up. The lead and generator were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. The device history records were reviewed confirming sterilization of the lead and generator prior to distribution. Good faith attempts for more 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2283457


Title: Re: Dehiscence
Post by: dennis100 on February 21, 2018, 02:03:56 AM
Model Number 102R
Event Date 09/26/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a patient's generator was explanted on (b)(6) 2016 due to an infection. The device history record of the generator was reviewed, and the device was sterilized prior to release. The generator was received on 10/04/2016. Analysis was approved on (b)(6)2016. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. No further relevant information has been received to date.

Event Description
The physician did not know when the infection began. The patient slowly developed wound dehiscence after implant in (b)(6) 2015 that led to an infection and visualization of the generator. This led to the explant. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6051125


Title: Re: Dehiscence
Post by: dennis100 on February 21, 2018, 02:04:41 AM
Model Number 104
Event Date 09/23/2011
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

Event Description
Reporter indicated a patient had the vns generator and lead removed on (b)(6) 2011 due to an infection and wound dehiscence at the generator site. The patient had vns generator replacement surgery performed earlier on (b)(6) 2011. It was unknown if the patient had any trauma or manipulated the incision sites. It was unknown what to attribute the infection to. The wound was cultured but specific results were not recalled. The patient has fully recovered from the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2416970


Title: Re: Dehiscence
Post by: dennis100 on February 28, 2018, 01:57:55 AM
Model Number 103
Event Date 02/25/2012
Event Type Injury
Event Description
On (b)(6) 2012, a vns implanting surgeon reported that the vns patient had an infection at the generator site and was scheduled to have his device explanted on (b)(6) 2012. The patient's mother first observed the infection on (b)(6) 2012 when she lifted the patient's shirt and saw the infection. The patient was known for picking at the generator site often. The patient was given antibiotics on (b)(6) 2012. Clinic notes dated (b)(6) 2012 were received. The patient presented with an open sore over the previous vns generator site that developed 3-4 days ago although, it was not noticed by the patient's mother until 1 day ago. The patient did not have a cellulitis fever or an extension of tenderness up the lead path to the neck. The patient's seizures were reported to be reasonably controlled on oral anti-seizures meds. The physician noticed a breakdown with granulation tissue, chronic, with a visible suture at the vns generator site. There was dehiscence at the vns generator site. The clinic notes stated that the patient was going to have iv antibiotics and removal of the vns generator and possibly the leads. The manufacturer's consultant later confirmed that the infection was due to the patient picking at the generator site. The generator and lead were removed on (b)(6) 2012. The surgeon noticed "pus" in the lead so he cut some of it out. Cultures were taken which confirmed the infection was staph aureus and was susceptible to antibiotics. 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=2493210


Title: Re: Dehiscence
Post by: dennis100 on March 01, 2018, 04:12:09 AM
Model Number 102R
Event Date 01/22/2007
Event Type Injury
Manufacturer Narrative
Initial report inadvertently did not indicate "30-day. ".

Event Description
Additional information was received as the previous implant card and operative report that indicate the explanted generator product information.

Manufacturer Narrative

Event Description
It was reported that the vns patient previously had his lead and generator replaced due to an unknown reason. Follow-up with the patient's previous surgeon found that the patient developed an infection following vns generator replacement due to end of service on (b)(6) 2006. The lead and generator were eventually explanted on (b)(6) 2007 after the wound was noted as "open and draining. " cultures were taken; however, the results were not available. The patient was later re-implanted on (b)(6) 2008. Attempts for the explanted generator product information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2477735


Title: Re: Dehiscence
Post by: dennis100 on March 07, 2018, 01:34:05 AM
Model Number 103
Event Date 05/23/2012
Event Type Injury
Event Description
Reporter indicated a patient had vns generator and lead explant surgery performed on (b)(6) 2012 due to infection. The patient was later reimplanted with a new vns generator and lead on (b)(6) 2012. The explanted vns generator and lead have been returned and are pending analysis. Attempts for further information are in progress.

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

Event Description
Product analysis was completed on the returned vns generator and lead. No anomalies were noted during the generator analysis and the generator performed per specifications. Note that a portion of 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. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.

Event Description
Reporter indicated that the infection was attributed to the patient experiencing a grand mal seizure, which caused the wound to open up and an infection to develop at the generator and lead sites. The grand mal seizure was a normal seizure type for the patient. Wound cultures performed grew out non-reamolite diphtheroids. The patient did recover from the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2634777


Title: Re: Dehiscence
Post by: dennis100 on March 07, 2018, 01:34:50 AM
Model Number 302-20
Event Date 01/23/2009
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 a pt developed an infection at the electrode incision site after the wound at the incision site partially opened. The wound opened because the sutures used in the implant procedure were not secured properly, and became loose. The medical professional was unsure whether or not any pt manipulation had occurred, which may have possibly contributed to the wound opening. The physician opened the wound completely, cleaned it, and allowed it to heal. The wound was re-closed once the infection cleared and the pt is doing well. There are no plans to remove the pt's device. No cultures were taken to identify the infection type. Dhr for the pt's lead and generator were reviewed, and sterility prior to shipment was confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1327917


Title: Re: Dehiscence
Post by: dennis100 on March 09, 2018, 03:16:30 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/06/2016
Event Type Injury
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

Event Description
Report received that a patient's generator and lead were explanted due to an infection. This occurred about 14 months after the initial implant. Further information was provided from the explanting surgeon that, at the time of the explant, the patient presented with wound dehiscence and an open pocket. The generator was reportedly seen coming out of this open wound with pus. There was reportedly no note of the patient picking at the generator. A review of the generator's device history record indicated it had been properly sterilized prior to release for distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7304683


Title: Re: Dehiscence
Post by: dennis100 on March 09, 2018, 03:17:18 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 02/02/2018
Event Type Injury
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

Event Description
It was reported that a vns patient was scheduled for explant of the generator and lead. The reason was later provided from the notes that it was because the vns incision has opened and is draining pus. Review of the manufacturing records for the generator and lead confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7287555


Title: Re: Dehiscence
Post by: dennis100 on March 11, 2018, 01:26:10 AM
Model Number 105
Event Date 07/03/2012
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

Event Description
An implant card was received indicating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.

Manufacturer Narrative
Corrected data: device manufacturing records were reviewed for the patient's lead. Review of manufacturing records confirmed sterilization for the lead prior to distribution.

Manufacturer Narrative
Date received by manufacturer (mo/day/yr) on supplemental report 01 should have been (b)(4) 2012, not 2015.

Event Description
It was reported that a vns patient had their device explanted for infection. Their infection was first noticed on (b)(6) 2012. The patient was placed on iv antibiotics and later oral antibiotics. Since removal of their vns generator their infection has resolved. There are no plans to reimplant the patient with another vns system. The patient a grand mal seizure and that is what caused their generator site to open and become infected. It was red,swollen, draining and smelling. Skin and blood cultures were negative but an obvious infection was present in ther generator pocket.

Event Description
The patient's generator was returned for analysis. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2676148


Title: Re: Dehiscence
Post by: dennis100 on March 11, 2018, 01:27:43 AM
Model Number 105
Event Date 09/09/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient was hospitalized on (b)(6) 2014. The patient was experiencing coughing, breathing issues, nausea, vomiting, and chest pain at the generator site. Patient also stopped eating and had lost weight. The patient¿s caregiver wanted the patient¿s device explanted as the events began when the device was programmed on a week after vns surgery. The patient¿s seizures had increased and patient was on more seizure medications than prior to vns therapy. However, the surgeon and neurologist stated that the patient is fine. The patient is diabetic and was admitted with a very high blood sugar level. The patient¿s physician believed the events were due to the patient¿s high blood sugar levels as well as vns stimulation. Following revealed that the patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

Event Description
On (b)(6) 2015, it was reported that the patient was scheduled for explant surgery as part of the incision site had opened and some of the generator is visible and exposed. The patient underwent removal of the vns on (b)(6) 2015. The explanted generator has not been returned for product analysis to date.

Event Description
It was reported that the hospital discards explanted devices and therefore the explanted generator cannot be returned for product analysis.

Manufacturer Narrative

Event Description
It was reported that the patient has been referred for surgery. The physician does not believe the events are related to vns therapy. No surgical interventions have been performed to date.

Event Description
Clinic notes were received stating that the patient was hospitalized due to reaction to the vns device. The patient¿s symptoms were reported to have been stable.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4194303


Title: Re: Dehiscence
Post by: dennis100 on March 13, 2018, 01:26:00 AM
Model Number 105
Event Date 08/03/2012
Event Type Injury
Event Description
On (b)(6) 2012, it was reported that there was fluid around a patient's device, that the incision site had opened, and that fluid was draining. On (b)(6) 2012, an implant card was received indicating that this patient underwent generator revision on (b)(6) 2012 due to an adverse event of 'protruding through skin. ' attempts for additional information will be made.

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

Event Description
Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. On (b)(6) 2012, it was reported that the patient had a skin breakdown at the left generator site. The patient presented to the emergency room, and underwent generator revision. On (b)(6) 2012, additional information was received confirming that the patient underwent generator revision on (b)(6) 2012. The patient presented to the emergency room with skin breakdown over the left chest with exposure of the generator. It appeared that an infection may have been starting, but no information was available regarding if cultures were taken to confirm an infection. It was also unknown if the seroma was verified. The patient was reportedly developmentally delayed; therefore, it was unclear if the patient was messing with the incision site or if another event preceded the event. The patient was on iv antibiotics after revision. The patient was seen on (b)(6) 2012 and was said to be doing well at that time.

Manufacturer Narrative
Event description, corrected data: previously submitted mdr inadvertently omitted text stating that the generator and lead were confirmed to have been sterilized prior to distribution. This report is being sent to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2722493


Title: Re: Dehiscence
Post by: dennis100 on March 20, 2018, 01:30:03 AM
Model Number 104
Event Date 06/30/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Following a generator replacement on (b)(6) 2016, patient generator incision opened up the next week. The site opened up enough that the generator was visible. This was noticed on (b)(6) in the evening. Patient underwent another surgery on (b)(6) to redo the incision suture. Patient saw the surgeon on (b)(6) 2016 and everything looked good. No infection noted at this time and patient did take antibiotics prophylactically after the first surgery. The nurse at the group home did not think that the picked at the incision to cause this. Additional information was received that the patient actually had been scratching at the dressing and was sensitive to tegaderm dressing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5822996


Title: Re: Dehiscence
Post by: dennis100 on March 24, 2018, 02:07:31 AM
Model Number 102R
Event Date 10/15/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient was referred for revision of the left vns wound.

Event Description
On (b)(6) 2012, it was reported that this vns patient would be undergoing surgery on (b)(6) 2012 for an unknown reason. Follow-up with the surgeon's office showed that after the patient's prophylactic generator revision on (b)(6) 2012, the patient began itching and picking at the incision site. As a result, the wound site had re-opened. Surgery was performed to adjust the pocket. There were no signs of infection. No devices were explanted or replaced. The event was attributed to patient manipulation and resolved with surgery.

Event Description
Additional information was received indicating that the second surgery took place on (b)(6) 2013 and was for the same reason as the 2012 surgery. The patient had been rubbing at the incision site, causing it to open again. The patient was seen postoperatively in (b)(6) 2013, and he was doing fine. The patient had not been seen or heard from again since then.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2837854


Title: Re: Dehiscence
Post by: dennis100 on April 03, 2018, 12:59:50 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
A patient's lead and generator were explanted due to an infection that led to dehiscence of the generator implant site. The device history records confirmed that the generator and lead were sterilized prior to distribution. No additional 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=6672054


Title: Re: Dehiscence
Post by: dennis100 on April 04, 2018, 01:03:39 AM
Model Number 304-20
Event Date 10/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that a physician had concern that t vns patient may be having an allergic reaction to the device. In the last 2 months, swelling and fluid collections were observed in the neck near where the leads are implanted. Cultures were taken and came back negative, so it was not believed to be an infection. The patient underwent lead and generator explant on (b)(6) 2012. The patient's neck wound was noted to be red a few weeks prior. At that time, it was cleaned; however, since that time, the wound had opened up. Pus was located at the electrode site during explant surgery. Cultures were taken but the results were not provided. The explanted generator and lead were returned on (b)(6) 2012 and are currently undergoing product analysis. Device manufacturing records were reviewed. 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.
 
Event Description
An analysis was performed on the returned lead portion. Note that the lead assembly (body) including a section of the connector boot containing the serial number tag and the electrode section was not returned; therefore it was not possible to verify the model and serial number during this analysis and 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 marked 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 product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The generator was returned: results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2915389


Title: Re: Dehiscence
Post by: dennis100 on April 07, 2018, 12:48:26 AM
Model Number 104
Event Date 01/04/2013
Event Type  Injury   
Event Description
It was reported that the patient had an explant surgery on (b)(6) 2013 where the vns generator and the lead were explanted and the patient was not re-implanted with a new product. The explanted products were returned to the manufacture on (b)(6) 2013 for product analysis which is underway.
 
Event Description
It was reported that the patient was taken into surgery because her vns generator site wound in the chest was wide open and was not healing. The patient had recently had vns generator replacement surgery performed on (b)(6) 2013. Communication with the physician revealed that he does not believe any patient manipulation or trauma might have caused or contributed to the event, and there were no medical changes. It was also revealed that the patient's wound would not heal and after an office visit on (b)(6) 2013 the surgeon would have noted a hematoma occurring for the third time since the generator replacement surgery on (b)(6) 2013. It was confirmed by the physician that they have tested for infection and no infection was found. It was stated that the patient would have the vns generator and lead explanted on (b)(6) 2013.
 
Event Description
Product analysis was performed and completed for the returned products. Results of diagnostic testing for the vns generator indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
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=2968019


Title: Re: Dehiscence
Post by: dennis100 on April 08, 2018, 12:56:08 AM
Model Number 103
Event Date 08/17/2012
Event Type  Injury   
Event Description
It was reported that the patient was being scheduled to have generator explant and to have the device replaced later in the week due to an unknown reason. Additional information was received indicating that the suture was opened, but an infection at the site was not confirmed to date. No manipulation is believed to have caused/contributed to the event. The generator and lead were both replaced. Attempts for additional information from the physician have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Product analysis for the explanted generator and lead was completed. 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. Additionally, electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Corrected data: the initial report inadvertently did not report this data. Review of manufacturing history records performed. Review of manufacturing history records of the generator and lead confirmed sterilization and all quality tests passed prior to distribution.
 
Event Description
The physician reported that there was no infection or related symptoms. Cultures were negative for infection. The patient had a "burning lesion" on the upper thoracic region "many years ago" correlated to difficult healing which compromised the skin around the vns generator. Therefore, the generator began extruding. Antibiotics were given to the patient orally. The generator and portion of the lead were explanted on (b)(6) 2013, but the lead electrodes were not explanted due to fibrosis. A replacement generator was implanted on the right side of the chest off-label. The patient's epileptic seizures have reduced significantly. The patient has responded well to the replacement surgery with no additional complaints, per the physician. Diagnostics after replacement were within normal limits. Product return is expected, but the devices have not been received by the manufacturer to date. The implant card confirmed the date of replacement of the generator and lead on (b)(6) 2013 with the reason marked as "dehiscence". Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated that the reason for explant was 'dehiscense' the patient was later reimplanted. The physician reported that 'everything was told' so no additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3021530


Title: Re: Dehiscence
Post by: dennis100 on April 09, 2018, 12:50:52 AM
Model Number 302-20
Event Date 01/30/2013
Event Type  Injury   
Event Description
Reporter indicated per the mother the infection was first noted on (b)(6) 2013, but redness at the incision site had been present since early (b)(6) 2013. The patient went to the hospital emergency room on (b)(6) 2013. On (b)(6) 2013, it was previously felt there was an issue due to ¿a piece of the electrode being visible in the neck¿, and the ¿electrode¿ was placed ¿lower¿ by the surgeon. The infection was felt to be due to ¿chronic low grade infection on foreign material (stimulator). ¿ no device manipulation or trauma occurred. Wound cultures were done which identified (b)(6) bacteria. The vns generator and lead were explanted on (b)(6) 2013.
 
Event Description
Additional information was received on (b)(6) 2013. The patient's wound was flushed and irrigated, and the lead was placed in a different location. Antibiotics were prescribed. A physician indicated that the patient was very slender and skinny: a tie-down was visible. The patient's parents did not notice anything in terms of patient manipulation or trauma. There had been no changes in the previous few months.
 
Event Description
On (b)(6) 2013, it was reported that, for some time, there was has been swelling at the neck incision site. The swelling is now red, and since a few days, the incision is open. The lead is visible. The generator and lead were to be explanted. Attempts for additional information have been unsuccessful.
 
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=2976167


Title: Re: Dehiscence
Post by: dennis100 on April 14, 2018, 12:41:07 AM
Model Number 103
Event Date 11/30/2012
Event Type  Injury   
Event Description
A surgeon's office reported that a vns patient was seen on (b)(6) 2013 and it was observed that their generator incision site was oozing and open. The patient was referred for a battery replacement and wound exploration, and antibiotics were prescribed. The patient has an ongoing issue with needing to have pocket revision surgery. A clinic note was received dated (b)(6) 2013. In her history it reports that the patient's generator had migrated into their breast tissue this was repositioned. Addressed in medwatch number: 1644487-2011-01242. Currently she is experiencing irritation and possible granulation/inflammation lower in the chest and in the breast with induration. Their device was interrogated and showed roughly 40-50% on the battery. The patient had their generator replaced on (b)(6) 2013. It has been returned for analysis but not completed at this time. Previously the patient went to surgery on (b)(6) 2012 for left chest wound exploration. The patient had a granulating wound of the left chest. The patient's granulation tissue was removed and immediately revealed the wires that were immediately under the skin. Another pocket was created and the generator and wires moved into it. She did well and was discharged.
 
Event Description
The generator was returned due to low battery and demipulse eos status unknown. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the lab. The battery is partially depleted, 2. 795 volts, at ifi, as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 104. 245% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
The patient was seen for followup on (b)(6) 2013. They continue to have migration and dehiscence issues with their new generator that was implanted (b)(6) 2013 addressed in medwatch report number: 1644487-2013-01211.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr) - corrected data; supplemental 01 sent with incorrect date of (b)(4) 2013 and it should have been (b)(4) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993042


Title: Re: Dehiscence
Post by: dennis100 on April 16, 2018, 01:14:31 AM
Model Number 304-20
Event Date 12/15/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
The explanted lead was returned to the manufacturer on (b)(6) 2013 and product analysis was performed. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. Scratches most likely caused during manipulation of the lead by the user were noted on the connector ring. Abrasions were identified on the connector boot and on the outer silicone tubing at multiple locations. The cut at the outer silicone tubing 17. 5 cm from the boot reached the inner silicone tubing of the lead coils, creating an opening. No obvious damage to the lead coils was noted at this location. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Based on the appearance of the analyzed lead portion, it is believed that the identified punctures, kinks, superficial cuts, etc. Were most likely caused during the explant procedure. Scanning electron microscopy images of the positive coil show that the coil was torn (most likely due to rotational forces). Scanning electron microscopy images of the negative coil show that the coil was torn at the electrode as indicated by the presence of the weld slug still attached to the end of the coil. Also, secondary fractures identified in two of the coil strands in the vicinity of the weld suggest that this condition was most likely result of the explant procedure. Note that since the electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations, typical wear, and explant related observations, no other anomalies were identified in the analyzed portions of the lead. No other information has been provided.
 
Event Description
Additional information was received through the investigation of the patient's generator explant due to inflammatory tissue and obvious wound opening (reported in manufacturer report number: 1644487-2013-00401), that the patient's lead was removed. It was stated that there lead was removed on (b)(6) 2013 from the patient due to a break in the sutures on the neck and direct exposure of the lead. The physician confirmed that the explant was due to the extruded wires as well as the inflammatory tissue which was related to the previously reported events in manufacturer report number: 1644487-2013-00401. No patient manipulation or trauma caused or contributed to the exposure of the lead. Attempts have been made for the return of the explanted lead for product analysis; however, the lead has not yet been returned. No additional information has been provided.
 
Event Description
Additional information had been received that the patient was re-implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075114


Title: Re: Dehiscence
Post by: dennis100 on April 17, 2018, 01:00:17 AM
Model Number 103
Event Date 04/14/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient surgical incision opened up after a generator and lead replacement. The patient had picked at the incision and opened up the scab and picked off all the overlying glue. The incision had begun bleeding. The patient reported that the incision had itched. The bottom of the chest incision was exposed but the subcutaneous stitches were still intact. There was no erythema at the incision site but there was some drainage. The neck incision was clean, dry and intact. The exposed incision was cleaned with hydrogen peroxide and then dermabond was used to reapproximate the skin edges. Once the dermabond was dried a dressing was placed over the incision and then layered with paper tape. The neck incision was also covered to prevent that site from being scratched.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3066120


Title: Re: Dehiscence
Post by: dennis100 on April 17, 2018, 01:01:09 AM
Model Number 302-30
Event Date 08/28/2008
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 clinic notes were received from (b)(6) 2008 which indicates that the patient recently underwent vns surgery and returned to the physician's office with some separation of her left neck and chest incisions, due to her picking at the incision sites and dressings. Additionally, the patient had significant contact dermatitis from her dressings. With betadine and valium this has all resolved. It was stated that the left neck incision is healing nicely although it does have mild superficial separation as well as her left chest incision. There is no surrounding erythema or drainage. Clinic notes dated (b)(6) 208 indicate that the patient underwent vns surgery 4 days ago and through the weekend developed an erythematous pruritic rash on her left chest an neck. The patient had completely removed her dressings and picked at her left neck incision causing superficial separation, apparently she continues to pick at her left neck. On exam, she had superficial separation of the neck incision, although fairly superficial. The physician stated that the erythematous rash over the left neck and thigh is consistent with tape irritation. The left chest incision had surrounding erythema as well, although it is covered with tegaderm dressing. The patient was given valium to provide some sedation and benadryl for her contact dermatitis. It was stated that the patient needs constant monitoring to prevent her from altering her incision further. Clinic notes dated (b)(6) 2008 indicated that he patient was seen one week ago and had significant dermatitis of her left chest and neck which is likely due to the dressing which was applied postoperatively. The patient was noted to have been picking at her dressings and removing them and then picking at her incision sites. On examination, the left neck incision is healing, although not completely closed. The physician noted that he undressed the left chest incision and revealed a small superficial separation. There were no obvious signs of infection. Clinic notes dated (b)(6) 2008 stated that the patient's wound is completely healed and she has no further rash. The surgeon and treating nurse practitioner were noted to have been retired for more than two years so no additional information would be available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3062982


Title: Re: Dehiscence
Post by: dennis100 on April 21, 2018, 01:35:11 AM
Model Number 103
Event Date 04/26/2013
Event Type  Injury   
Event Description
Further follow-up revealed that the infection was first observed on (b)(6) 2013. The physician indicated that the patient¿s caregivers kept picking up the patient by the armpits which did not allow the incision to heal properly and the wound dehisced. The infection was at the left chest incision.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the vns patient was explanted on (b)(6) 2013 due to an infection. Cultures were taken which were positive for (b)(6). It was reported that the generator and only a portion of the lead were explanted. The electrodes were left on the nerve and the lead was cut at approximately clavicle level. Attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3129631


Title: Re: Dehiscence
Post by: dennis100 on April 23, 2018, 12:48:11 AM
Model Number 103
Event Date 04/01/2013
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.
 
Manufacturer Narrative

Event Description
On (b)(4) 2013 product analysis was completed on the explanted generator. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
There was no known relationship of their events to any patient manipulation or trauma. Unknown relationship to their vns device. The patient's explanted generator was returned for analysis and pending completion. Cultures were taken on (b)(6) 2013 from chest site. Few staphylococcus and rare staphylococcus species coagulase negative. It was reported that their pocket failed to heal.
 
Event Description
It was reported via clinic notes that a vns patient was having difficulties with their vns pocket. They had a battery replacement (b)(6) 2013 and at that time their vns pocket was revised. Their sutures were removed. She then experienced dehiscence of their more superior wound and generator migration of their generator to the surface. It was granulating. The patient was scheduled for , incision, drainage, debridement and closure of the left chest wound. The patient had a wound debridement and incision and drainage on (b)(6). The superior wound was debrided of granulation tissue. The inferior wound had a small soft area in the middle. It appeared that there was a connection subcutaneously between the two wounds with some fluid present. This was evacuated. A small area of atropic skin was inferiorly excised. Copious bacitracin irrigation was used prior to closure. The patient was seen for their postop visit on (b)(6) and their incision was intact. There was some serosanguinous drainage likely from removal of their granulated tissue. The patient was put on keflex prophylactically and was to be seen again on (b)(6) for followup and to decide next plan of care. The patient thought her skin incision looked thin and was concerned about opening. On (b)(6) the patient's generator was removed and it was decided to let their pocket heal prior to generator replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3120397


Title: Re: Dehiscence
Post by: dennis100 on May 03, 2018, 01:21:05 AM
Model Number 105
Event Date 06/01/2013
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
On (b)(6) 2013, it was reported that the patient did not have an infection. Cultures were taken three times and were negative and inclusive. The patient had wound dehiscence, and the skin over the generator was very thin. There was barely any tissue left when the patient was seen (b)(6) 2013. The wound opened, exposing the generator as they were going in for surgery (in or right before or). The patient did not have the generator replaced: the generator was implanted deeper. Surgery was on (b)(6) 2013. The cause was unknown, but it was likely related to the patient¿s physiology and response. No known trauma or change that would have caused the issue. The patient had not been seen since surgery.
 
Event Description
It was initially reported that the patient had a infection at the generator site. The patient apparently had the infection for weeks. The patient was recently implanted (b)(6) 2013. The patient was having surgery to either revise or remove the vns. It has not been confirmed which was done. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3223298


Title: Re: Dehiscence
Post by: dennis100 on May 06, 2018, 01:22:35 AM
Model Number 103
Event Date 05/23/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 were received. The patient came in for a follow up for the vns implant which occurred on (b)(6) 2013. The notes state that the patient attends today with plication of a small amount of the skin at both incisions which was necrotic and sloughed off. Now these areas are wider. The subcutaneous tissues are clearly exposed. The physician states that he did not see any evidence of the device. The physician exam found no evidence of surrounding infection. The skin is healthy and clean. The neck incision looks well healed. Per the notes, the surgeon states that the best thing to do is to take the patient back to the operating room and reclose the skin, as this would hopefully prevent infection, particularly in view of the patient's past history of infection (the patient's first vns was "lost due to infection" of (b)(6) - previously reported in manufacturer report #: 1644487-2012-00700). Clinic notes dated (b)(6) 2013 indicate that post vns insertion is complicated by infection removal. The vns placement was done okay, apart from the chest incision, where the skin has dehiscenced slightly. A physician exam indicates the incision on the chest dehiscenced in two places. Operative notes from (b)(6) 2013, indicate the patient's generator was explanted. When the chest incision was opened, there was a large amount of pus in the pocket around the generator. This was all evacuated and sent for culture and sensitivity. The neck incision was opened and pus was seen to be around the lead. The three electrodes were individually removed with the lead in its entirety. The lead and generator were both completely removed. Pulse irrigation was then used on both the neck and chest incisions to significantly clean this out and half inch gauze was then placed into the incisions. The patient was seen on (b)(6) 2013 and her incisions were treated with dressing changes. A physician exam indicated that her incisions were open, but red and granulating. The notes indicate that the isolated organism is staphylococcus aureus, which is sensitive to cipro and clindamycin i. The physician gave the patient this for 21 days in addition to further hydrocodone for pain. Notes dated (b)(6) 2013, found that the patient said she was unable to take the clindamycin and was not able to afford the cipro. Per the notes, the patient now has enough money to start the cipro again and has no new problems. Per a physical exam, the neck incision was well healed and the chest incision is still open but is granulating. There is no evidence of infection. The plan at this juncture, per the notes, is that the patient should restart cipro and would be seen in three months. The device manufacturing records for both the generator and lead were reviewed. Sterilization was confirmed. The patient's last programmed settings from (b)(6) 2013 was found in the manufacturer's internal programming history database.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3292619


Title: Re: Dehiscence
Post by: dennis100 on May 08, 2018, 02:02:22 AM
Model Number 102
Event Date 06/10/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent explant after experiencing a severe wound infection. It was reported that the patient was seen at a hospital and was given antibiotics. Then approximately a month and a half later, the patient was seen by the physician to have the device explanted. It was reported that cultures were negative, but that they were most likely negative due to the antibiotics the patient took. The physician indicated that the patient may have induced the infection by "scrubbing" the infection and because of his low socio-economic status. Further follow-up revealed that the patient experienced a focal axillar dehiscence three weeks post op which had reported healed after a few days. It was reported that two months post op the patient experienced major wound dehiscence with purulent discharge. Attempts to have the device returned for analysis have been unsuccessful to date. It was reported that the hospital is refusing to release the device.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3355839


Title: Re: Dehiscence
Post by: dennis100 on May 10, 2018, 12:49:07 AM
Model Number 102
Event Date 09/02/2013
Event Type  Injury   
Event Description
It was reported that the patient underwent explant due to an infection at the chest generator site. It was reported that the patient was seen outpatient to have the device programmed on and that is when the infection was found. It was reported that the hospital decided to explant on the same date. It was reported that the hospital would not release the explanted devices to manufacturer. It was reported that the physician has not intent on implanting another vns system. It was reported that the infection was not related to vns. There was not patient manipulation or trauma. No culture were taken. It was reported that the wound was open because of the improper implant placement of the generator, which caused the infection.
 
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=3487391


Title: Re: Dehiscence
Post by: dennis100 on May 13, 2018, 12:41:36 AM
Model Number 102
Event Date 06/27/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported by a medical professional that a vns patient who was a subject to a clinical study had presented adverse events: adverse event 1: cutaneous inflammation which started on (b)(6)-2013, ended on (b)(6)-2013. The event was not ongoing at the time of the report. The severity was indicated as moderate. Relationship to implant: definite. Not related to stimulation. Action taken: treatment withdrawn. Other action taken: surgery. Outcome: recovery/resolved. This adverse event caused the subject to discontinue the study. The adverse event was serious and it resulted in an initial or prolonged hospitalization. Adverse event 2: recurrent nerve palsy which started on (b)(6)-2013 and was still ongoing at the time of the report. The severity was indicated moderate. Relationship to implant: definite. Not related to stimulation. Action taken: n/a. Other action taken but not specified. Outcome: no recovery/not resolved. This adverse event did not cause the subject to discontinue from the study. The adverse event was serious and it resulted in a persistent or significant disability or incapacity. Further information was received indicating that there were no system diagnostics. The patient was admitted to (b)(4) hospital because of an inflammatory scar with redness and blistering without purulent fluid. No fever, no functional or general symptoms. Skin samples taken were negative. The day after the hospitalization, the scar opened by breaking of the blisters exposing the devices. It was decided to explant due to the risk of infection. The inflammation was at the level of scar. The left vocal cord was paralyzed during explant surgery. The patient was evaluated by an internal of the ear nose throat department, but no results of the exploration were sent to the manufacturer. Explant surgery had been performed on (b)(6)-2013. Resumption of two previous incisions was done. Inflammatory tissue, no purulent fluid found. Explant of the vagus nerve stimulator and electrodes was completed. Surgical cavities were washed and the edges of the scar resected. No general signs. The patient has intraoperative left recurrent laryngeal nerve palsy. Dysphagia to liquids with risk of aspiration. Normal solid diet. The surgical scar was clean and the patient was discharged on (b)(6)-2013.
 
Event Description
Additional information was received stating that the study patient¿s cutaneous inflammation was determined to be moderate device extrusion. The patient¿s recurrent nerve palsy was determined to be severe recurrent nerve paralysis which began on (b)(6) 2013. The patient was also experiencing moderate dysphagia on (b)(6) 2013 possibly due to vns implant and stimulation which also caused the patient to withdraw from treatment. The patient was recovering. The event was not considered serious.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3521478


Title: Re: Dehiscence
Post by: dennis100 on May 16, 2018, 01:57:27 AM
Event Type  Injury   
Event Description
The abstract of the article ¿vagus nerve stimulation therapy in epilepsy patients. Long-term outcome and adverse effects: a retrospective analysis¿ was received and reviewed by the manufacturer. Please see abstract below: ¿background: vagus nerve stimulation (vns) is one of the numerous stimulation procedures used in the treatment of neurological diseases in which there has been growing interest in recent years. Since 1988 it has been frequently used in the therapy of epilepsies but the mechanism of action is still unknown. It is considered to be low in adverse effects. Topics: decision-making process on vns therapy as well as long-term outcome and adverse effects. Method: retrospective analysis of all 62 patients treated over a long period by vns in the epilepsy center of the university hospital of freiburg (germany) from (b)(6) 2002 through (b)(6) 2011. Results: outcome: the results show that 2 out of 62 patients became seizure-free under vns therapy while maintaining the already existing anti-ictal medication and 4 more patients under vns plus dosage increase of the already existing medication and/or new medication. However, in 34 out of 62 patients vns therapy did not improve the seizure situation. Adverse effects: vns is not as low in adverse effects as is generally considered. Only 9 out of 62 patients did not show any adverse effects and on the other hand severe, even life-threatening adverse effects also occurred. Conclusion: patients undergoing vns therapy have to be carefully checked for possible adverse effects, not only at the beginning of vns therapy but also in the long-term course. These results have to be considered in the cost-benefit analysis of this treatment. ¿ the article, written in german, was later received by the manufacturer. Per the article, thirteen patients experienced adverse events related to the vns surgery or vns. A translation of the chart with patient information and outcomes revealed the following adverse events were observed: necrosis, increase in seizures (that were possibly psychogenic), wound infections, secondary rupture of sutures, recurrent laryngeal nerve paresis, horner¿s syndrome, wound dehiscence, lead break, and asystole. The following manufacturer report numbers are associated with each patient and their respective events: mfr #: 1644487-2014-00031 -- asystole, associated with vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 -- lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00040 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.
 
Manufacturer Narrative
Date of birth, corrected data: initial mdr inadvertently provided the incorrect information. Sex, corrected data: initial mdr inadvertently stated this information was unknown; however, the information was known at the time. If implanted, corrected data: initial mdr inadvertently provided the incorrect information. Describe event or problem, corrected data: the initial mdr inadvertently referenced the related mfr numbers incorrectly. The following manufacturer report numbers are associated with each patient¿s respective events reported in the article: mfr #: 1644487-2014-00031 -- asystole related to vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery and psychotic episodes associated with vns. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 ¿ lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00040 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.
 
Manufacturer Narrative

Event Description
Follow up with the physician was performed. The physician stated that he had reported these events to the manufacturer in time and he was not willing to support any further dialog regarding these issues. The physician confirmed that there were no critical situations around the vns and that in cases where vns was critical, the device had been disabled and/or explanted. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3549167


Title: Re: Dehiscence
Post by: dennis100 on May 22, 2018, 02:24:24 AM
Model Number 304-20
Event Date 01/03/2014
Event Type  Injury   
Event Description
The patient underwent generator and lead reimplant.
 
Event Description
The physician reported that there is a "5 mm open area that appears to be a wire" on the patient's neck. The patient's brother was observing the patient and stated that he believed the patient rubbed the area and created the opening. The patient had a consult for surgery on (b)(6) 2014. System diagnostics were normal. The surgeon attributes the exposure to patient manipulation. No medication or treatment changes preceded the issue. The family was not aware when the issue started. The patient has been referred for surgery. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative

Event Description
It was reported that the generator and lead were explanted and that the patient will be reimplanted in about two weeks. It was reported that there was some concern about the patient developing an infection. The patient was placed on antibiotics.
 
Event Description
Additional information was received stating that the vns patient has not been re-implanted to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595152



Title: Re: Dehiscence
Post by: dennis100 on June 05, 2018, 02:45:39 AM
Model Number 102
Event Date 10/01/2007
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
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1590826


Title: Re: Dehiscence
Post by: dennis100 on June 08, 2018, 03:00:10 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 04/28/2018
Event Type  Injury   
Event Description
It was reported from the physician that a patient¿s vns generator and lead were removed due to a believed infection at the chest, however cultures were negative. It was stated that there was wound dehiscence at the chest which was the location that was believed to be infected. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544810


Title: Re: Dehiscence
Post by: dennis100 on June 16, 2018, 01:32:37 AM
Model Number 103
Event Date 03/19/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a seizure caused the dehiscence. The patient underwent another revision on (b)(6) 2014. The physician indicated that a resection of a neuroma in both the generator site and electrode site occurred. The patient later underwent explant of both the generator and lead. No additional relevant information has been received to date.
 
Event Description
The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2014 due to inflammation, dehiscence, and extrusion of the lead at the generator site. In (b)(6) 2014, the patient presented with drainage at the generator site. The surgeon stated that no infection had developed and attributed the event to vns implant surgery. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012570


Title: Re: Dehiscence
Post by: dennis100 on July 03, 2018, 12:17:29 AM
Model Number 102
Event Type  Injury   
Event Description
It was reported that a vns pt developed an infection in the chest generator site area and was referred for generator removal surgery as well as removal of part of the lead near the generator. At the moment it is unk when the infection started and what could have contributed to the infection as good faith attempts to obtain additional information have been unsuccessful to date. Furthermore, the surgeon's office indicated the pt's generator was visible through the incision site and it was unk if pt manipulation or trauma contributed to the event. The pt underwent explant surgery as scheduled and at the moment the name of the explanting site is unk.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1801202


Title: Re: Dehiscence
Post by: dennis100 on July 06, 2018, 08:52:19 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 05/24/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was stated that a patient may have a wound around her generator site that had opened up and led to infection, due to patient twiddling or manipulation. The patient was scheduled for a full revision surgery. Device history records were reviewed for the patient's devices. Both lead and generator were sterilized and passed all quality inspections prior to distribution. A battery replacement surgery occurred and impedance was ok. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7596391


Title: Re: Dehiscence
Post by: dennis100 on July 06, 2018, 08:52:51 AM
Model Number 1000
Device Problem No Known Device Problem
Event Date 04/06/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
Report received that a patient developed a chest wound that appeared dehisced. Additionally, the patient's neck appeared red and swollen. The patient had been implanted with a new lead and generator only about a month before these issues were seen. The surgeon reportedly admitted the patient to perform a partial explant and washout. It was later confirmed that the generator and part of the lead were explanted. Further information was received that the chest wound was caused by the patient picking at the chest incision which caused it to become infected. It reportedly developed into (b)(6). The neck redness and swelling was reportedly indicative of an infection, too. A review of the device history records for the lead and generator indicated that both devices had been sterilized per specification prior to being released for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7592560


Title: Re: Dehiscence
Post by: dennis100 on July 07, 2018, 04:13:29 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? no, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient underwent generator and lead explant due to infection and extrusion. Additional information was received that the patient had a infection about 6 weeks after first implant. Patient underwent surgery to clean and flush the area and was provided with antibiotics. About 4 weeks after this surgery, the devices were removed via another surgery due to the wound opening and the generator and lead coming up under the skin. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650669


Title: Re: Dehiscence
Post by: dennis100 on July 08, 2018, 01:50:40 AM
Device Problem No Known Device Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported from the patient that she had high blood pressure after surgery. She took blood pressure pill and it got better. She also says the incision came apart at some point, but was put back together. It is unclear which incision she is referring to. She states her incision on her chest is red and swollen. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7566864


Title: Re: Dehiscence
Post by: dennis100 on July 10, 2018, 07:17:04 AM
Model Number 102
Event Date 08/01/2010
Event Type  Injury   
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the pt had surgery to remove the vns device due to infection and cellulitis. Pt went to er on (b)(6)2010 as her caregivers found the generator site had opened up (generator was visible) and was draining. Physician prescribed antibiotics. The device was removed (b)(6)2010 and the infection site was debrided and cleaned. The surgeon thought perhaps the pt's body had rejected the implant which caused the infection. However, per neurologist, the generator became loose and migrated slowly over 5 years to the pt's armpit, and came out. Once it was exposed to air, the infection started. It was also noted that the pt was likely manipulating the device which may have contributed to the events. Pt will be reimplanted in the future in a different location to prevent pt manipulation of the device. Explanted product was returned to the mfr and underwent analysis. Upon analysis, no anomalies were noted. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1833656


Title: Re: Dehiscence
Post by: dennis100 on July 18, 2018, 03:05:11 AM
Model Number 106
Event Date 02/24/2016
Event Type  Injury   
Event Description
It was reported on (b)(6) 2016 that the patient has swelling at the chest incision. The patient was implanted on (b)(6) 2016. The swelling was described as raised and warm to touch. The vns device is not on. There is no neck swelling. Of note, the patient does cpt (chest percussion therapy) vest therapy. He did cpt the 1st day postop and there was some bleeding of the chest incision site, so since then the cpt therapy has been discontinued. Follow-up with the surgeon's office showed that the patient was seen on the 10th. It was determined that the patient had a seroma above the chest incision and antibiotics were prescribed as a precaution for any infection that may develop and the seroma was drained at the appointment. No infection was confirmed but the precautionary medicines were provided. The patient's home was instructed to give the antibiotics. No explant of the device is planned. On (b)(6) 2016, it was reported that the patient's lead wire is poking through the incision.
 
Event Description
The generator and the lead were explanted on (b)(6) 2016.
 
Event Description
Clinic notes received (b)(4) 2016 and dated (b)(6) 2016 states that patient has problems with lead. It was stated it was complicated by a small seroma which was evacuated 2 weeks ago. The patient returns today with a small portion of the vns lead extruding through the skin. This is in the area where the seroma had thinned out the wound. There is no sign of infection or drainage. The surgeon recommends revising the pocket in such a way that his leads will be placed back in the tissue deeper. Due to the patient's mental status, this will have to be done in the or. The patient's surgical intervention has not occurred to date due to the patient being hospitalized for pneumonia and dehydration.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the patient was taken to the hospital due to a hemotoma. The surgeon performed surgery that day to clean out the generator site due to the lead being exposed. System diagnostics performed at this surgery showed the device was working within specifications. It was reported on (b)(6) 2016 that the patient underwent a surgery that morning. It was stated that the patient had a hemotoma at the chest incision and the lead wire was still poking through the skin. The surgeon cleaned out the hematoma, covered the area in antibiotic powder and put a wound vac in place that he planned to keep in through the weekend. Per the nurse, the patient thrashed around a lot, picked at his incision site and they felt that was contributing to the problems.
 
Event Description
It was reported on (b)(6) 2016 that the patient is referred for explant as it appears that his body is rejecting the lead/generator. The patient now has an open incision. No confirmation of the explant surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529930


Title: Re: Dehiscence
Post by: dennis100 on July 19, 2018, 06:01:44 AM
Model Number 103
Event Date 12/19/2014
Event Type  Injury   
Event Description
It was reported that the patient developed an infection at the generator site and would undergo generator explant. It was reported that the surgeon would clean the generator pocket and then making a new generator pocket and implanting another generator. It was later reported that the patient presented to surgery with a badly infected generator pocket with an open wound and the generator missing. It was reported that the lead was sticking out of the pocket with the lead pins torn off. It was presumed that the lead pins were still connected to the missing generator. The surgeon decided to explant the lead and let the mrsa infection heal before re-implanting in 2-4 weeks. It was reported that the patient did not know what happened to the generator. The surgeon indicated that the chest wound broke down and extruded. The patient initially had a seroma, but that the generator eventually extruded through the skin. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative

Event Description
Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. On 03/11/2015 it was reported that the physician lacerated the carotid artery of the patient during the re-implant surgery. A vascular surgeon was called in to assist. After 7 hours, the patient appeared to be stable and was sent to the icu to stay the evening.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532501


Title: Re: Dehiscence
Post by: dennis100 on August 07, 2018, 01:05:19 AM
Model Number 102
Event Date 04/17/2007
Event Type  Injury   
Manufacturer Narrative
Device mfg records were reviewed. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported via clinic notes that vns pt developed infection at the generator site. Three weeks after vns generator re-implantation, the pt developed redness purulence from the chest incision. Despite iv antibiotics, this wound worsened with increasing fluid collection underneath the wound. The generator pocket became swollen and the neurosurgeon drained the excess fluids. At this point, the surgeon decided to remove pt's vagal nerve stimulator and drain the postoperative wound infection. The pre-existing incision which had largely dehisced. The physician used pulse irrigator and irrigated extensively; however, the infection recurred so he used a suction drain. Dhr review of the generator showed that both generator and the lead were sterilized with hp on (b)(6) 2006. The pt was later reimplanted on (b)(6) 2010 with a new vns generator and lead. Good faith attempts to obtain additional info from the implanting surgeon have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956374


Title: Re: Dehiscence
Post by: dennis100 on August 10, 2018, 03:50:12 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/04/2018
Event Type  Injury   
Event Description
It was reported that surgery was being taken to reposition the patient's generator as the generator had migrated to an axillary position. It was also reported that the generator had been replaced recently and since there had been issues with wound healing and the wound had opened. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726467


Title: Re: Dehiscence
Post by: dennis100 on August 10, 2018, 03:50:41 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/11/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had their generator and lead explanted due to an infected collection of fluid around the battery. The patient had been on antibiotics continuously since implant in (b)(6) 2017. Prior to explant, the patient had two neck wound revisions due to would dehiscence. During the second case of wound dehiscence, the patient's electrode coil was "trying to escape. " review of the manufacturer's device history records verified sterilization of the lead and generator prior to release. Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7723003


Title: Re: Dehiscence
Post by: dennis100 on August 11, 2018, 01:02:34 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2018
Event Type  Injury   
Event Description
It was reported that a vns patient was referred for surgery as the incision site had opened, and was infected. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7664030


Title: Re: Dehiscence
Post by: dennis100 on August 14, 2018, 12:42:27 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? (b)(4). Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
Further information was received that the generator incision site opened and the device could be seen. This was reportedly caused by the previous infection that returned. As a result, the generator and lead were explanted. No additional relevant information has been received.
 
Event Description
Report received that a patient developed an infection at the chest incision site within three months of initial implant. The area was debrided and reclosed. A review of the generator device history record indicated it had been sterilized according to specification prior to being released for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7293377


Title: Re: Dehiscence
Post by: dennis100 on August 25, 2018, 06:00:48 AM
Model Number 105
Event Date 04/15/2011
Event Type  Injury   
Manufacturer Narrative
Method: device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was initially reported on (b)(6) 2011 that the pt had been admitted to the hospital due to an infection and was scheduled to have her generator explanted. The pt had been picking at her incision site. She was previously provided oral antibiotics, but the infection did not improve. Additional information was rec'd from the surgeon indicating that the infection was first observed right after implant. Cultures of the infection indicated that the infection was methicillin-resistant staphylococcus aureus. The infection site was described as "grossly purulent". The generator was explanted, but no other interventions were taken or planned. The surgeon again indicated that the pt had scratched open her incision site, causing the infection. The infection has since resolved. Manufacturer records indicated that both generator and lead were sterilized by hydrogen peroxide prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133615


Title: Re: Dehiscence
Post by: dennis100 on September 07, 2018, 11:01:40 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/13/2018
Event Type  Injury   
Event Description
It was reported that the patient was referred for a possible revision surgery and is currently admitted to the er. The surgery was stated to be a wound washout surgery. Design history record for the generator was reviewed. The generator was confirmed to have been hp sterilized prior to distribution. Further information and operative notes were received. Both the generator and lead were explanted. The patient is developmentally delayed and had been picking at the site prior to the surgery. The wound was fully open when he came in. Operative notes stated drainage and fever were noted. The cultures were consistent with infections; therefore, iv meds were administered in conjunction with his ancef. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? code 81, device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7790584


Title: Re: Dehiscence
Post by: dennis100 on September 07, 2018, 11:02:26 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/27/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.
 
Event Description
It was reported that a patient's device was explanted due to infection. The patient had had a recent battery replacement surgery which had opened up. It was stated that the mom did not get an antibiotic order filled, so the wound led to infection and the device was visible. Device history records were reviewed for the implanted devices. Both the lead and generator were sterilized and passed all quality inspections prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7750790


Title: Re: Dehiscence
Post by: dennis100 on September 12, 2018, 02:31:54 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


Title: Re: Dehiscence
Post by: dennis100 on October 03, 2018, 07:07:19 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/21/2018
Event Type  Injury   
Event Description
The infection stated in the initial report was made incorrectly, as there was no report that the patient had experienced an infection. There was no sign of an infection per the physician. No additional or relevant information has been received to date.
 
Event Description
It was reported that the patient had picked at the generator's incision site and had reopened the wound causing a part of the generator to extrude through the skin. Also, the patient had developed an infection at the generator incision site. The patient's generator was subsequently replaced. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Describe event and patient code; corrected data; initial mdr submitted incorrect data as there was no infection.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7741433


Title: Re: Dehiscence
Post by: dennis100 on October 05, 2018, 12:33:03 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


Title: Re: Dehiscence
Post by: dennis100 on October 06, 2018, 05:12:27 AM
Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/16/2018
Event Type  Injury   
Event Description
It was reported that a patient was scheduled for a lead revision due to extrusion of the lead caused by the patient picking at his device. It was stated that the generator might also be replaced in case of infection. An update was received after the surgery occurred indicating that no revision or replacement occurred. It was stated that there was "wound dehiscence from a white tab", likely referring to a tie down. The wound was fine with no infection and was reclosed after removing the tie downs. Further clarification was then received that the devices were not visible through the wound, and that the incision site had just opened up as a result of the patient's picking. Device history records were reviewed for the lead product. The device was sterilized and passed all quality inspections prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7863106


Title: Re: Dehiscence
Post by: dennis100 on October 11, 2018, 06:41:30 AM
Model Number 104
Event Date 05/30/2012
Event Type  Injury   
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day".
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient's vns had been previously explanted due to an infection and now wanted to be re-implanted. The patient's mother indicated that the patient picks at the wound site. Follow-up with the physician's office found that drainage was noted at the wound site on (b)(6) 2010. The patient underwent debridement on (b)(6) 2010. The next note indicated that blood blisters were observed around the generator site per the patient's mother on (b)(6) 2011. The patient was then seen in the clinic on (b)(6) 2011 and the patient was taken to the or on (b)(6) 2011 for irrigation and re-suturing of the generator pocket. A note dated (b)(6) 2011 indicated that the patient pulled out 7 of his stitches. The generator was explanted on (b)(6) 2011 due to "multiple infections. " a later note dated (b)(6) 2011 indicated left wound revision "with plastics. " cultures taken on that date indicated (b)(6). The patient's parent elected to not have the lead removed at that time. A note dated (b)(6) 2011 indicated "infection with dehiscence evident. " the entire lead was removed on (b)(6) 2011. Cultures taken on that date indicated (b)(6). Antibiotics were used throughout the treatment of the infection.
 
Event Description
Additional information was received indicating the patient has been reimplanted with a new vns lead and generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2618817


Title: Re: Dehiscence
Post by: dennis100 on October 15, 2018, 11:41:35 AM
Model Number 102
Event Date 07/25/2012
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, a vns surgeon's coordinator reported that the vns patient was scheduled for an incision and drainage surgery on the chest wound on (b)(6) 2012 and her generator will be explanted at the same time. The patient's generator pocket/incision was infected/dehiscence. The patient had recently undergone battery replacement surgery on (b)(6) 2012. It was later discovered that the surgery was postponed until (b)(6) 2012. The surgeon plans on explanting the generator and then repositioning the lead, leaving it fully intact. The infection will be healed before the patient is re-implanted with a new generator. The device was explanted as planned. The surgeon believes that the patient picked at the sutures at the generator incision in the patient's left chest which caused the infection/dehiscence. Cultures were taken but the results were not provided. 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=2706616


Title: Re: Dehiscence
Post by: dennis100 on October 25, 2018, 02:43:50 AM
Model Number 103
Event Date 07/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that, about one month prior, a surgeon explanted a patient's device due to infection. (the exact date of explant is unknown. ) the patient presented to the office with an open wound and exposed generator. The patient was reportedly doing great with seizure control, so replacement was anticipated once the patient was healed. A review of manufacturing records showed that the generator and lead were sterilized prior to distribution. Attempts for additional information have been unsuccessful.
 
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=2724140


Title: Re: Dehiscence
Post by: dennis100 on October 27, 2018, 12:59:24 AM
Model Number 103
Event Date 08/17/2012
Event Type  Injury   
Event Description
A vns patient reported that they had their generator and lead explanted for an infection at the electrode site. The family wants device replaced if possible once their infection heals. Thus far no further information has been attained.
 
Manufacturer Narrative
Describe event or problem: omitted off initial report.
 
Event Description
Additional information was received. The patient's surgeon reported that their explant was more related to a rejection to the implanted products, not an infection. It is possible that picking at the wound led to the eventual dehiscence, but the exuberant tissue overgrowth was likely the main problem and not related to the trauma or manipulation. Cultures were taken from the neck incision when the vns was explanted on (b)(6) 2012. They grew out staph aureas. The patient was treated with antibiotics starting (b)(6) 2012 and the extruded neck lead was reimplanted after re-exploration and thorough irrigation on (b)(6) 2012. Their infection has resolved. At this time they do not plan to re-implant it since i believe the patient's hypertrophic reaction is a rejection to the device material.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterlization for both the lead and generator prior to distribution.
 
Event Description
The patient's explanting surgeon reported to the patient's mother that at the time of explant it was noted that there was a lot of scarring and thin, loose skin around the device, probably causing the patient to feel some pain since not enough fat to insulate the device. The patient did not report any pain events prior to their explant event. Prior to explant in (b)(6) 2012, the patient was having coughing and dysphagia with stimulation. The patient's surgeon reported that their explant was more related to a rejection to the implanted products not an infection. It was reported that the vns seemed to reduce the patient's seizures as was reported to have had only 1 big seizure (b)(6) 2012. The patient was having seizures again since their device was explanted. No further information has been received at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2794269


Title: Re: Dehiscence
Post by: dennis100 on November 01, 2018, 02:45:20 AM
Model Number 103
Event Date 10/24/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was later reported on (b)(6) 2013, that the vns patient had passed away on (b)(6) 2013 (death reported on mfr. Report # 1644487-2013-00234). It was stated that she had previously had the vns removed because it had come open and there was a possible infection.
 
Event Description
On (b)(6) 2012 it was reported that the vns patient was having an issue with her wound closing. It was later reported that the patient was admitted for gi issues and someone said that they could see the patient's vns device. The patient was noted to often use restraint type straps in a stroller. It was later reported that the surgeon decided to remove the patient's generator on (b)(6) 2012 as she believed the patient was picking at the site causing the problem with the wound healing. The surgeon stated that she would not put another vns in the patient due to her being a picker.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2836402


Title: Re: Dehiscence
Post by: dennis100 on November 06, 2018, 07:23:23 AM
Model Number 304-20
Event Date 01/06/2013
Event Type  Death   
Manufacturer Narrative
 
Event Description
On (b)(6) 2013, it was reported that the vns patient has passed away on (b)(6) 2013. It was also reported that the physician does not know anything yet about the cause of death and are waiting for the autopsy to be performed which will take time. It was stated that when they have more information they will provide it to the manufacturer. The patient was only implanted with a vns lead at the time of death as the generator had been previously explanted on (b)(6) 2012, due to the wound not closing, extrusion, and possible infection (reported on mfr. Report # 1644487-2012-03036). The surgeon believed that the patient had been picking at the site causing the problem with the wound healing. The patient's obituary was found online which indicated that the patient had passed away in the hospital. A sudep evaluation was performed by the manufacturer with the information available and it was determined to be a possible sudep at this time.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the manufacturer of the patient's medical device is not eligible to obtain a copy of the patient's death certificate in the state the patient passed away in according to their department of vital records.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2935007


Title: Re: Dehiscence
Post by: dennis100 on November 08, 2018, 01:47:36 AM
Model Number 103
Event Date 11/27/2012
Event Type  Malfunction   
Event Description
The return product form indicates the generator was explanted due to "vbat < eos threshold". Product analysis was performed on the returned generator. The premature eol (end of life) was duplicated in the product analysis lab. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the surgical procedure. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccum consumed memory locations revealed that 6. 035% of the battery had been consumed. No additional information has been provided.
 
Event Description
Reporter indicated a patient developed a wound infection at the vns generator site pocket in the chest on approximately (b)(6) 2012. The patient had been recently implanted with the generator on (b)(6) 2012. The wound was noted to be open on (b)(6) 2012. The vns lead was visible at the height of the left breast. The vns generator was performing as intended and working properly. Oral antibiotics were given, and the patient had wound debridement and irrigation surgery performed with high-pressure iodum solution. Antibiotics are to continue. The cause of the infection may be due to the recent implant surgery, but the patient may have also had trauma/device manipulation that may have contributed to the infection.
 
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.
 
Event Description
Reporter indicated the vns lead was removed due to infection on (b)(6) 2013, but the generator remained in the patient. The patient was implanted with a new generator and lead on (b)(6) 2013. The generator was replaced as it was felt it had been damaged by electrocautery use during the (b)(6) 2013 lead removal surgery. The explanted generator was returned on (b)(4) 2013 and is pending analysis. The explanted lead was not returned.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution. The lead information is currently unknown; as such a review of the lead manufacturing records is not possible.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2899542


Title: Re: Dehiscence
Post by: dennis100 on November 09, 2018, 02:36:06 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Event Description
It was initially reported that the patient was scheduled for a surgical washout which was believed to be due to an infection. During the surgical procedure, it was reported that there was no infection present, but rather the patient's wound had dehisced due to the patient picking at their device. The device history record showed that both the lead and generator were sterilized prior to distribution. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7985174


Title: Re: Dehiscence
Post by: dennis100 on November 13, 2018, 07:08:51 AM
Model Number 104
Event Date 01/06/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this patient was seen in clinic on this date with an open chest incision and infection. Per the patient's mother, the patient did not pick at the incision site. Clinic notes dated (b)(6) 2013 indicated that the patient's mother noticed on (b)(6) 2013 that the battery incision had opened up and that there was swelling. The patient was seen in the emergency room, bandaged up, and sent home. The patient's mother stated that the patient had a chest x-ray that revealed normal generator placement and an ultrasound looking for abscess that was also normal. The patient was prescribed amoxicillin which improved the swelling significantly; however, while the wound had closed somewhat, it was still slightly open. It was noted that there was a 1/2 centimeter opening in the inferior portion of the patient's chest incision, purulent drainage and culture. There was tenderness with palpitation. Notes from the patient's (b)(6) 2012 appointment did not note any problems with vns. Cultures were taken after five days of antibiotics and returned (b)(6) for (b)(6). On (b)(6) 2013, the patient underwent full explant. The infection was noted to have spread up to the lead site.

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=2958323


Title: Re: Dehiscence
Post by: dennis100 on November 17, 2018, 04:39:19 AM
Event Date 03/25/2013
Event Type  Injury   
Manufacturer Narrative

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3074526


Title: Re: Dehiscence
Post by: dennis100 on November 19, 2018, 08:00:58 AM
Model Number 104
Event Date 03/01/2013
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
It was reported that the patient underwent surgery to explant the remaining portion of the lead on (b)(6) 2013.

Event Description
It was reported that the patient's generator site was infected and that the patient was referred to surgery. It was reported that the patient was originally scheduled for "closure" surgery; however, the surgeon decided to do a generator replacement to be safe and that it was being considered to place the new generator on the patient's right chest area. It was reported that the surgeon was uncertain if the infection was due to surgery or the presence of the device. There was no trauma or manipulation that occurred; however, it was reported that the patient may have picked at the incision. Clinic notes dated (b)(6) 2013 indicated that the patient had an open wound on the chest and that the patient's father reported that the wound was still draining and that the neurologist recommends that the vns be moved to the right site to allow abscess on the left to heal. Clinic notes dated (b)(6) 2013 indicated that the chest abscess was excised on (b)(6) 2013 and that the patient's mother reported that the wound was draining yellow with some odor. Further follow-up revealed that the patient underwent explant on (b)(6) 2013. It was reported that the plan is to reimplant a vns system in 5-6 months after the wound heals. Both the generator and lead were returned to device manufacturer for analysis on (b)(4) 2013. Product analysis is underway; however, had not yet been completed to date. The patient's father reported on (b)(6) 2013 that he was in the hospital with the patient due to the infection. The father reported that he was under the impression that both generator and lead were explanted; however, the patient underwent a ct scan which showed that a portion of the lead was still implanted. The father reported that the patient's infection has spread to the patient's neck where the lead portion is still implanted. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Event description, corrected data:the mfr. Report 03 inadvertently reported that the surgery was to replace the remaing portion of the lead.

Event Description
It was reported that the patient underwent surgery to replace the remaining portion of the lead on (b)(6) 2013.

Event Description
Further follow-up revealed that the patient was explanted due to possible infection at the site of incision. Reimplant is planned when the patient has healed. The returned product form indicates the generator and lead were returned; however, the reason was not marked. The op note revealed that the patient has an open wound of the chest and is for repair of chest wound from vagal nerve stimulation hematoma and possible skin flap with removal of vagal nerve stimulation. The generator and lead were received into product analysis on (b)(6) 2013. Analysis of the generator indicated that the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead will be reported in mfr report # 1644487-2013-01235.

Event Description
Further follow-up revealed that the physician did not believe that the vns system was related to the infection. Cultures were taken at the hospital; however, the results were not known.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3053763


Title: Re: Dehiscence
Post by: dennis100 on November 22, 2018, 03:02:07 AM
Model Number 103
Event Date 05/01/2013
Event Type  Injury   
Event Description
On (b)(4) 2013, it was reported by the surgeon that the patient was recently implanted on (b)(6) 2013 and came into the hospital on (b)(6) 2013 with a wound on her neck. It was stated that the patient fell in the shower from a seizure and her neck incisions were ripped open. After the patient went to the hospital, her sutures were removed and the surgeon re-sutured the wound and closed it. No other interventions were taken or planned. Diagnostic results were ok. Follow up with the nurse at the surgeon's office found that the wound was not related to vns. It was stated that the wound was directly caused by the seizure incident which was unrelated to vns. No known medication changes preceded the event. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3137281


Title: Re: Dehiscence
Post by: dennis100 on December 03, 2018, 04:20:38 AM
Model Number 102R
Event Date 06/19/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, additonal product information was received.

Event Description
On (b)(4) 2013, it was reported that the explanted products were discarded.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent full explant due to infection. The physician believed that the patient twiddled which may have been the cause of the infection. Cultures were taken and came out negative for (b)(6), but the physicians still believe there is an infection. The patient was on antibiotics. Follow-up showed that the explant surgery took place on (b)(6) 2013. The patient¿s father noticed on (b)(6) 2013 that the chest incision site had split open. The patient went to the emergency room and then underwent explant. The patient was scheduled for a later lead revision due to high impedance. The high impedance event is captured in mfr report #1644487-2013-01959.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3202684


Title: Re: Dehiscence
Post by: dennis100 on December 07, 2018, 10:47:39 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient underwent a full vns explantation surgery. It was noted that the patient was "a picker. " follow up with the patient's neurologist revealed that the patient was explanted due to a post-operative hematoma that compromised the patient's respiratory airway. A review of device history records revealed that both the lead and generator were sterilized prior to distribution. The explanted products were received by the manufacturer and are pending product analysis. The explant data form received with the products indicated that a dehiscence wound was present at the generator site. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8081287


Title: Re: Dehiscence
Post by: dennis100 on December 15, 2018, 02:43:13 AM
Model Number 105
Event Date 07/15/2013
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
It was reported that the patient experienced an infection shortly after implant. The patient was given antibiotics and then the infection would subside, but would flare up again after the antibiotics were discontinued. It was reported that this was a continuous process until the surgeon felt that the generator needed to be removed to help heal the site. It was reported that the chest area had erythema on (b)(6) 2013. The patient was given a 10 day course of keflex. The patient also received two 3 day courses of keflex (one in (b)(6) after the initial 10 day course had ended and one in the beginning of (b)(6)) for dental reason. On (b)(6) 2013 the patient was seen and put on 2 weeks of keflex for left chest incision abcess. On (b)(6) 2013 the patient was seen in the office with open neck and chest incision with drainage. The physician reported that the patient's lead could be seen coming through the neck. The patient underwent explant on (b)(6) 2013. The patient was discharge on antibiotics. It was reported that the cause of the infection is unknown. No patient manipulation or trauma occurred that could have caused or contributed to the infection. Cultures were positive for staph aureus. It was reported that reimplant will occur after the patient had a few more months to heal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3425741


Title: Re: Dehiscence
Post by: dennis100 on December 16, 2018, 04:17:27 AM
Model Number 303-20
Event Date 09/15/2013
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.

Event Description
It was reported that the patient presented to the emergency room on (b)(6) 2013 with redness at the incision site and was sent home. The following day the neck incision opened up and the patient was seen by the surgeon's pa on (b)(6) 2013 and was sent to the emergency room to have the wound closed with suture and the patient was sent home. It was reported that the wound again opened up on (b)(6) 2013 and the patient was admitted to the hospital and infection was noted. The patient underwent vns system explant on (b)(6) 2013. It was reported that there was pus up into the lead in the neck and chest area. Cultures were taken; however, the results were not yet available. It was reported that the infection was believed to be due to the patient picking at the incision site. Reimplant is likely, but has not occurred to date. The lead and generator were returned on (b)(6) 2013. The generator analysis was completed on (b)(6) 2013. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead analysis was completed on (b)(6) 2013. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead assembly were performed with no discontinuities identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. There is no evidence to suggest an anomaly with the returned portion of the device.

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

Event Description
Clinic notes dated (b)(6) 2013, 17 days post vns implant, indicate the patient's seizures had decreased slightly, there was less postictal effect, the patient was more alert, and the magnet worked to stop a seizure. However, the notes state that the operation site over the unit was puffy, but not red, warm, or tender. The patient had a very low grade fever that started five days ago. The site was swollen and tender to touch. The low grade temperature was 99 to 100 degrees. No redness or drainage was noted. At this time, the physician did not think there was a wound infection and did not start the patient on antibiotics. The patient's medication and vns settings were changed. The device was removed on (b)(6) 2013. Per the notes, the patient was having about five seizures per week. They usually occured right after he falls asleep or awakens. Bilateral arms and legs pull up and stiffen, lasting 15 to 30 seconds. Clinic notes dated (b)(6) 2013 were received which indicate the patient's vns device was removed due to the infection. The notes state that the patient would be re-evaluated the next month for having the device replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414426


Title: Re: Dehiscence
Post by: dennis100 on December 18, 2018, 01:02:51 PM
Model Number 102
Event Date 09/06/2013
Event Type  Injury   
Manufacturer Narrative
Brand name, corrected data: follow-up showed that the suspect medical device was a model 102 generator. This information was inadvertently omitted from supplemental report 01. Attempts for the device serial number have been unsuccessful. Model, corrected data: follow-up showed that the suspect medical device was a model 102 generator. This information was inadvertently omitted from supplemental report 01. Attempts for the device serial number have been unsuccessful.

Manufacturer Narrative
Serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.

Event Description
It was reported that the patient underwent surgery to reposition the generator because the generator was coming out of the incision. The surgeon reported that the generator had just been placed and that the pocket was not big enough and this was the reason the generator was coming out of the incision. The surgeon deepened the pocket and repositioned the generator. The surgeon indicated that device diagnostics were within normal limits following the surgery. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Product information was obtained.

Event Description
Follow up with the physician found that there was no trauma or manipulation. No infection found after cultures were taken. Parents called because they believed they could see an opening at the generator site. The physician reported that the generator may need to be to deeper location in the left chest. Wound dehiscence performed on (b)(6) 2013. Patient's device was repositioned on the (b)(6) 2013. No causal or contributory medication or diet changes (affecting wound healing) preceded the onset of the event. It was clarified that the device was repositioned in surgery, and not replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3388554


Title: Re: Dehiscence
Post by: dennis100 on December 18, 2018, 01:03:37 PM
Model Number 103
Event Date 09/05/2013
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
It was reported that the patient was involved in a fight which caused the chest incision to open up. The physician indicated that he believes the generator site is infected. Culture were performed, but showed no growth; however, the physician reported that the patient had already been on antibiotics at the time the cultures were performed. The physician indicated that explant is planned. Surgery is likely, but has not occurred to date.

Event Description
Additional information received revealed that the patient had the device explanted on (b)(6) 2013. No signs of infection were found during a follow-up appointment post device removal. The patient will have another appointment next year to determine what the next steps will be.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406168


Title: Re: Dehiscence
Post by: dennis100 on January 15, 2019, 03:20:00 AM
Model Number 103
Event Date 03/01/2013
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
It was reported that the patient has an infection and will undergo generator explant. It was reported that the lead will be left in place. It was reported that reimplant is planned at a later time. It was reported that the patient has a chronic neck infection that appears to be associated with the vns. Several types of antibiotics were tried ; however, the neck incision reopened again. It was noted that a small amount of granulation tissue is in the medial aspect of the neck wound. The patient underwent generator explant on (b)(6) 2014. It was reported that the explanted device will not be returned for analysis. The physician reported that the infection started six months following implant. The patient became sick and was hospitalized. The physician reported that the infection started at the generator site and traveled to the neck through the tunneled site. It was reported that the neck wound grew (b)(6). Multiple antibiotics were administered and the neck site was ok. The physician reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the infection. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3815763


Title: Re: Dehiscence
Post by: dennis100 on January 15, 2019, 03:20:45 AM
Model Number 103
Event Date 04/28/2014
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
It was reported that the patient underwent generator replacement. It was reported that the surgeon wanted the device discarded because it was infected. No analysis can be performed as the device was discarded.
 
Event Description
Clinic notes were received for the vns patient¿s office visit with the neurosurgeon on (b)(6) 2014. The notes indicate that the patient developed a dehiscence at the generator site several weeks prior to the office visit. The dehiscence had been draining either yellow or clear fluid. Cultures showed only normal skin flora at the generator site. Antibiotics have not been helpful and the patient continued to have drainage. The patient was referred for surgery for wound debridement and deeper generator placement. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the vns patient¿s generator incision site was red and leaking yellow fluid. The patient did not have any fever or pain. Further follow-up revealed that the generator could be visualized through a pin-sized hole at the patient¿s generator site. Yellow fluid was reported to be draining from the site. Cultures were negative. The patient was given an antibiotic regiment. No known surgical interventions have occurred to date. 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=3824799


Title: Re: Dehiscence
Post by: dennis100 on January 17, 2019, 02:53:25 AM
Model Number 103
Event Date 01/14/2014
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
It was reported that the recently implanted vns patient underwent surgery to explant her device on (b)(6) 2014. High levels of serous secretion and signs of infection were observed at the generator site with 50% wound dehiscence. There were no signs of trauma at the generator site. The generator site had not improved since implant so the patient¿s device was explanted. The generator pocket was washed out with antibiotics following generator explant. One of the electrodes could not be explanted due to fibrosis which the physician attributed to vns. The remaining portion of the lead was explanted and the wound was washed out with antibiotics. Cultures were (b)(6) and the patient was given an antibiotic regiment. Further follow-up revealed that the infection developed at the generator site approximately three month following implant surgery. The patient is not expected to be re-implanted. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
The lead and generator were returned for analysis on 02/27/2015. Product analysis for the lead was completed on 03/18/2015. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis for the generator was completed and approved on 03/24/2015. Potential contributing factors to the infection have been considered / evaluated and none were found to exist in this situation. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 023 volts as measured during completion 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.
 
Event Description
The patient was discharged in (b)(6) 2014 because the infection was resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899763


Title: Re: Dehiscence
Post by: dennis100 on January 25, 2019, 09:39:54 AM
Model Number 103
Event Date 07/21/2014
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
The physician reported that the cultures were positive for staphylococcus aureus. It was reported that the generator and a portion of the lead were explanted. The physician reported that the infection was a result of implant surgery and the presence of the device. There wa no patient manipulation or trauma that is believed to have caused or contributed to the infection. The device protrusion was secondary to the wound infection and wound dehiscence. The patient is now stable and did not experience systemic symptoms and the local infection has resolved.
 
Event Description
It was reported that the patient was seen in the emergency room the past friday night. The patient was started on antibiotics and did not have any fever. The patient was scheduled to see the surgeon. The patient had recently undergone generator replacement. The patient was seen by the surgeon who drained "milky fluid" from the wound at the chest pocket. The area was flushed and cultures were taken. The surgeon administered iv antibiotics. The surgeon believes an infection is present and was considering explant. It was later reported that the patient was experiencing wound dehiscence. The patient's family feels the device needs to be removed. The patient was admitted to the hospital and underwent generator explant. It was reported that the lead was left in place. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4018076


Title: Re: Dehiscence
Post by: dennis100 on January 26, 2019, 03:59:07 AM
Model Number 102
Device Problem Insufficient Information
Event Date 06/16/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns study patient developed an infection on (b)(6) 2014 at the incision site. Furthermore, the patient¿s incision site reportedly had opened. The infection was attributed to the vns implant surgery. The patient was hospitalized from (b)(6) 2014. The patient underwent surgery on (b)(6) 2014 to explant the generator and lead.
 
Event Description
Further information indicated that the event ended on (b)(6) 2014. The patient recovered. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Manufacturer Narrative
Pt age at time of event: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth for the patient. Pt gender: the previously submitted mdr inadvertently provided an incorrect sex for the patient. Operator of device; corrected data: the previously submitted mdr inadvertently provided the wrong device operator for the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3987355


Title: Re: Dehiscence
Post by: dennis100 on January 27, 2019, 09:50:37 AM
Model Number 105
Event Date 07/11/2014
Event Type  Injury   
Event Description
The patient has decided not to re-implant the vns device for fear of infection recurring.
 
Manufacturer Narrative
Conclusions, initial report inadvertently omitted. Conclusion code for device discarded.
 
Event Description
It was reported that the patient was scheduled for surgical exploration of the generator incision site. It was reported that the patient's wound was not healing poorly. The operative notes dated (b)(6) 2014 note that the patient is an avid hunter and shoots his gun from his left shoulder. It was noted that the generator is implanted on the right side of the patient's chest. It was noted that the patient was admitted to the hospital on (b)(6) 2014 with the medial 1-2 cm of his right chest incision broken down and a small piece of the lead and generator exposed. Further follow-up revealed that cultures were negative for infection. The patient was taken back to the hospital on (b)(6) 2014 because the incision opened up again. The patient underwent generator explant. It was reported that the lead was left in place. The patient requested explant of the device. The surgeon plans to wait a couple of months with the generator removed so the incision can heal and then reimplant another generator. There was no known cause for the impaired incision healing. It was reported that the patient has had good healing prior to vns implant. The explanted generator was discarded; therefore, will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4051959


Title: Re: Dehiscence
Post by: dennis100 on February 02, 2019, 08:29:01 AM
Model Number 103
Event Date 02/12/2014
Event Type  Injury   
Event Description
It was reported that the patient was scheduled to undergo lead explant due to infection. It was reported that the generator was previously explanted due to the infection. The surgeon indicated that the patient underwent generator explant on (b)(6) 2014 and lead replacement on (b)(6) 2014. The patient had wound dehiscence and pus. The surgeon reported that there was no patient manipulation or trauma that caused or contributed to the infection.
 
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=4163742


Title: Re: Dehiscence
Post by: dennis100 on February 03, 2019, 03:50:57 PM
Model Number 103
Event Date 08/11/2014
Event Type  Injury   
Event Description
Initially, it was reported that the patient underwent generator replacement for an unknown reason. Further follow-up revealed that the generator was replaced due to left anterior chest wound dehiscence with purulent drainage. The patient underwent a "washout" of the left anterior chest wall with generator replacement. No patient manipulation or trauma occurred that is believed to have caused or contributed to the wound dehiscence. There were no medication changes that could have caused or contributed to the wound dehiscence. The explanted generator was received for analysis. Analysis was completed on 09/22/2014. 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.
 
Manufacturer Narrative
Method: 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=4281354


Title: Re: Dehiscence
Post by: dennis100 on February 06, 2019, 02:46:34 AM
Model Number 103
Event Date 11/14/2013
Event Type  Injury   
Event Description
Analysis of the generator showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the vns patient developed an infection and subsequently underwent surgery to explant the device. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. The patient has not been re-implanted to date.
 
Event Description
Additional information was received regarding the infection. In the month of (b)(6) 2014, a follow up appointment showed a dehiscent wound and infectious secretions. The culture showed e. Coli. Patient was admitted (b)(6) 2014. Patient's generator was explanted on (b)(6) 2014 and patient was discharged on (b)(6) 2014. Patient was readmitted (b)(6) 2014 due to secretions from the wound and extrusion of the electrode from the chest site, for which he was hospitalized and explanted partially on (b)(6) 2014. Culture showed staphylococcus aureus. He was kept in the hospital to receive antibiotic therapy. The explanted generator was returned on (b)(4) 2015. Analysis is underway but has not been completed.
 
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=4347863


Title: Re: Dehiscence
Post by: dennis100 on February 07, 2019, 02:42:04 AM
Model Number 302-20
Event Date 10/20/2010
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
It was reported that the vns patient developed an infection and dehiscence due to patient manipulation of the lead site which caused the lead to extrude from the patient¿s skin. The patient underwent surgery on (b)(6) 2011 to explant the generator and lead. Follow-up revealed that the patient¿s incision site had never fully healed. The patient previously underwent surgery on (b)(6) 2010 to revise the incision site. 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=4442128


Title: Re: Dehiscence
Post by: dennis100 on February 09, 2019, 02:39:00 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/26/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event "have" been determined as not related to vns therapy.
 
Event Description
It was reported that the patient¿s generator was exposed after their replacement incision had been opened during a bicycle accident. The patient¿s generator and a portion of their lead wire were removed. The patient was reported to have had an infection, and the infected encapsulation tissue was removed. The devices were discarded and will not be returned. Device history records were reviewed and the generator and lead were sterilized and passed all specifications prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8258460


Title: Re: Dehiscence
Post by: dennis100 on February 09, 2019, 02:39:49 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient's generator and lead were explanted due to infection and wound breakdown with no immediate replacement. Further clarification was received that the infection was at the vns generator site and the wound had stated to dehisce. The explanted devices were returned. It was further stated that the patient had been in-patient for 4 days with glucose readings of over 400 mg/dl every night. The surgeon stated that the glucose being uncontrolled was a contributing factor to the infection. Device history records were reviewed for the implanted devices and were noted to have been sterilized and passed all quality inspections prior to distribution. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8241440


Title: Re: Dehiscence
Post by: dennis100 on February 10, 2019, 03:50:26 AM
Model Number 304-20
Event Date 11/06/2014
Event Type  Injury   
Event Description
The explanted product was received by the manufacturer for analysis.
 
Event Description
Analysis was completed on the explanted products. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. 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 which may have contributed to the stated complaint. 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.
 
Event Description
It was reported that the patient's caregiver noticed an internal infection about two weeks prior at the neck incision site. The patient had implant surgery on (b)(6) 2014. The infection was reported to have developed to be external with scabbing on the left side of the incision. The infection was not mentioned or visible at post-operative follow-up, as the company clinical specialist was present during most of the patient¿s appointments. No interventions for the infection have been reported to date.
 
Event Description
It was later reported that the patient¿s lead was extruding after the incision opened on (b)(6) 2015. The patient was seen in the emergency room and evaluation by the surgeon confirmed that the vns explant was warranted. The hospital reported that the generator and lead were explanted on (b)(6) 2015 due to infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4385251


Title: Re: Dehiscence
Post by: dennis100 on February 12, 2019, 03:17:54 AM
Model Number 105
Event Date 01/29/2015
Event Type  Injury   
Manufacturer Narrative
Suspect device udi: (b)(4). Additional manufacturer narrative and/or corrected data: suspect device udi was inadvertently left out of the initial mdr.
 
Event Description
It was reported that the patient underwent initial vns implant and that on the way home from the surgery the patient scratched at the generator incision so much that the incision opened and the generator was pulled out along with several inches of lead body. The patient was taken back to the hospital where generator and lead (including electrodes) explant occurred. It was reported that the explanting facility plans to keep the explanted products for investigation and that product return may not occur for some time. It was reported that the plan is to let the patient heal and consider reimplant at a later date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535664


Title: Re: Dehiscence
Post by: dennis100 on February 13, 2019, 02:55:23 AM
Model Number 105
Event Date 01/28/2015
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
It was reported that the vns patient was picking at the generator site and opened the wound, causing infections to develop at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to explant the device. The patient has not been re-implanted to date. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
This information was inadvertently left off of previous mfr. Report: suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4553967


Title: Re: Dehiscence
Post by: dennis100 on February 14, 2019, 02:10:13 AM
Model Number 304-20
Event Date 02/18/2015
Event Type  Injury   
Event Description
It was reported that the patient underwent generator and lead replacement due to an infection. It was reported that the lead was rejected and that it is believed that the infection was caused by a bacteria that the patient brought to the operating room. Cultures showed staphylococcus aureus. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. Surgical notes indicate that the wound dehiscence is suspected to be caused by hypoproteinemia from neurological deterioration of the patient as the patient will not eat solid foods.
 
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 lead was completed on 04/02/2015. Note that the electrodes were 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 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 at one time. Additional setscrew marks found on the 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. Analysis of the generator was completed on 04/06/2015. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4636128


Title: Re: Dehiscence
Post by: dennis100 on February 19, 2019, 03:41:28 AM
Event Date 12/19/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the physician that the patient's lead was extruding in the patient's neck with redness at the site. The surgeon did not believe an infection was present; however the surgeon elected to reposition the lead. Follow-up with the surgeon's office learned that the patient had scratched at the neck site leading to dehiscence of the wound. This eventually led to a 2cm opening in the neck. The patient was admitted to the hospital and put on iv antibiotics, the surgeon reportedly performed a multi-layer closure and closed the opening. No indication of infection was present. The surgeon reported that he caught the wound opening early, so there were very few complications. The patient is now reportedly well healed and the patient's sutures have been removed. No other contributory factors are believed to have been present other than the manipulation of the wound by the patient. Attempts for the lead model and serial number have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2418508


Title: Re: Dehiscence
Post by: dennis100 on February 28, 2019, 03:28:17 AM
Model Number 105
Event Date 05/01/2015
Event Type  Injury   
Event Description
It was reported that the patient is scheduled for a explant due to infection at the generator site. Patient underwent generator replacement on (b)(6) 2015 and acquired an infection following the surgery. Antibiotics were provided to patient and wound dehiscence was observed at the generator site. The device was explanted and a subcutaneous drain was placed on (b)(6) 2015.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4883555


Title: Re: Dehiscence
Post by: dennis100 on March 01, 2019, 02:27:24 AM
Model Number 102R
Event Date 07/08/2015
Event Type  Injury   
Event Description
Additional information was received that the patient's generator was removed and that the lead was coiled up and secured in the chest so that it could not migrate. The caregiver reported that the patient had a hard time with the infection (she reported it was so bad that it had traveled up the wire) and an open wound after implant of the vns. Patient had an open wound at the vns incision site. Because of the wound, the patient has been in wound care therapy until the device was removed. The wound was reportedly still present, but was described as an open wound about the size of an eraser that still had fluid discharge. The wound was reported to be almost fully healed. The infection is reported in mfr. Report # 1644487-2016-02286.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A report was received indicating that a patient had scratched her surgical incision to the point that the implanted generator was showing. Surgical intervention was undertaken to close the opened incision. The generator was left in the same location and no products were explanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953442


Title: Re: Dehiscence
Post by: dennis100 on March 01, 2019, 02:28:21 AM
Model Number 105
Device Problem Improper or Incorrect Procedure or Method
Event Date 03/25/2015
Event Type  Injury   
Manufacturer Narrative
Describe event or problem, corrected data the following statement was inadvertently not reported in supplemental mdr 1 : "it was reported that the patient had had some inflammation at the electrode site in (b)(6) 2016 and so the patient received an injection of kenalog in the electrode site. " the following statement was inadvertently not reported in supplemental mdr 2: "it was reported that the patient's physician had not believed that the patient's lead had extruded from a boil. It was believed that the patient had dug it out of her skin. ".
 
Event Description
It was reported that the patient developed an infection after the vns was implanted. The patient reported that the sutures were removed too soon and the incision opened up. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
It was reported by the surgeon that there was no infection noted. It was reported that the staples were removed at 10 days and the patient returned days later and 3 staples were replaced for 10 days. The patient is very thin and has thin chest wall. The physician reported that due to the patient's poor wound healing in the past the staples will be left in for 2 weeks if the patient undergoes vns replacement in the future. The patient was prescribed prophylactic antibiotics after re-stapling the incision. The physician indicated that the patient manipulated the generator and lead sites. It was reported that the incision opening was dealt with promptly and that the patient is "skin and bones"; therefore, it was not possible to place the generator with excess skin overtop. Clinic notes dated (b)(6) 2015 note that the generator is palpable but there was no evidence of infection.
 
Manufacturer Narrative
(b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
The patient reported that the lead wire is extruding and that it formed a boil and popped out. The patient is not currently being seen by a neurologist or neurosurgeon as the patient has a history of drug abuse. Mfr. Report # 1644487-2015-05357 previously reported that the patient dug the lead out of her skin and deliberately cut the wire.
 
Event Description
It was reported that the patient had had some inflammation at the electrode site in (b)(6) 2016 and, so the patient received an injection of kenalog in the electrode site. It was reported that the patient's physician had not believed that the patient's lead had extruded from a boil. It was believed that the patient had dug it out of her skin.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949590


Title: Re: Dehiscence
Post by: dennis100 on March 07, 2019, 02:00:18 AM
Model Number 304-20
Device Problem Insufficient Information
Event Date 07/30/2015
Event Type  Injury   
Event Description
Additional information was received stating that the patient's physician did not believe that the event was related to vns surgery. The patient had been seen several times following surgery and the patient's incision sites had healed well. The physician concluded that the patient's symptoms were superficial during the office visits. The incisions sites were cultured and treated with an appropriate antibiotic regiment. Patient manipulation or trauma is not believed to have caused or contributed to the event, and no known medication or diet changes preceded the onset of the event.
 
Event Description
It was reported that the vns patient presented with drainage at the generator site and inflammation at the neck incision site. The patient was subsequently given antibiotics. Follow-up revealed that the infection-like symptoms were reported by the physician to be superficial, isolated to the patient¿s skin, and not related to the implanted devices. Patient manipulation or trauma is not believed to have caused or contributed to the event. Additional information was received stating that the vns patient went to the hospital as his neck incision site had opened and exposed the patient¿s lead. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4964297


Title: Re: Dehiscence
Post by: dennis100 on March 09, 2019, 02:43:20 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/31/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events (dehiscence wound, extrusion, and infection) are not related to the functionality or delivery of therapy of the device.
 
Event Description
The physician's assistant reported that a patient had their vns explanted due to wound dehiscence and lead extrusion, which led to a mrsa infection. The physician's assistant mentioned that during the explant, it was found that the lead coils could not be removed due to fibrosis. The physician's assistant clarified that the patient has a lower level of function, so patient manipulation was to blame for this extrusion, infection, and explant. Device history records were reviewed and showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. 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. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8311627


Title: Re: Dehiscence
Post by: dennis100 on March 11, 2019, 07:58:30 AM
Model Number 106
Event Date 08/28/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient's incision site had opened. Additional information was received that the patient's wound was re-stitched. No infection was noticed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5094043


Title: Re: Dehiscence
Post by: dennis100 on March 12, 2019, 03:37:10 AM
Model Number MODEL 304
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/04/2015
Event Type  Injury   
Event Description
Product information was received for the explanted products.
 
Event Description
Additional information was received that the patient underwent a generator and lead re-implant surgery on (b)(6) 2016, indicating that the infection had cleared. No additional relevant information has been obtained to date.
 
Event Description
It was reported that the recently implanted vns patient was needing device explant due to site infection. Additional information was received from clinic notes that the patient's chest incision was healing normally but that the neck incision was open in the midline with the vns wire exposed. Infection was confirmed. The vns was disabled and system diagnostics showed normal lead impedance. Additional information was received that the patient did not report any picking at the incision site. It was unknown how the infection began, other than from the incision site from surgery which did not heal properly. The generator and lead were explanted from the patient on (b)(6) 2015 due to the infection.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5071307


Title: Re: Dehiscence
Post by: dennis100 on March 13, 2019, 01:39:02 AM
Model Number 304-20
Device Problem Insufficient Information
Event Date 08/07/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had experienced wound dehiscence at the electrode incision site due to manipulation. The patient received medical intervention. The area was drained and a new suture was performed. The physician did not see any evidence of an infection, but did prescribe antibiotics. The physician believed that the patient's caregiver applied pressure to the incision during bathing, which caused the wound to open.
 
Event Description
It was reported that the physician performed drainage of an abscess on (b)(6) 2015. He then decided to remove the entire vns system due to infection with secretion at the generator site. The patient was not hospitalized for this procedure. The cause of the infection was probably due to the mother of the patient cleaning the incision site roughly with some contaminated product or bacteria on the skin. The infection was located at both the generator and incision sites. No culture results were available, but the physician indicated that there were signs of infection. A review of the device history records showed that the generator and lead were sterilized prior to release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5059042


Title: Re: Dehiscence
Post by: dennis100 on March 14, 2019, 06:21:26 AM
Model Number 304-20
Event Date 12/01/2014
Event Type  Injury   
Event Description
It was reported on (b)(6)2015 that the patient¿s incision is starting to open and the patient¿s mother thinks she can see the lead wires. The patient¿s most recent vns surgery was a full revision on (b)(6) 2014 (captured in file (b)(4)). The mother first noticed it appeared ¿bubbly¿ on (b)(6) 2015 and the physician put the patient on antibiotics. Things then seemed better. However, the morning of (b)(6) 2015 the patient¿s crusty scab fell off and now the patient¿s mother thinks she can see the lead. The patient¿s physician noted that the extrusion was located at the left axilla. He noted that the patient¿s previous re-implants of generators through the initial axillary led to the battery migration laterally to incision twice (b)(6) 2014 and (b)(6) 2015. The physician indicated that the patient has generalized seizures where the patient strikes her chest and has a tendency to pick at the incision line. The first dehiscence was in (b)(6) 2014 and was treated with antibiotics and the generator was placed deeper with layered closure to prevent migration. No causal or contributory medication or diet changes (affecting wound healing) preceded the onset of the extrusion. There was no infection, just exposure to surface bacteria. Cultures showed results of skin flora, ¿staph epi¿.
 
Event Description
Additional information was received that the patient's lead wires were coming out of the patient's arm pit incision site. The generator is in place but the excess lead has migrated to the arm pit and is extruding from the old incision site. Patient underwent surgery to reposition the lead wires on (b)(6) 2016. Patient manipulation is not suspected to be the cause. According to the surgeon, patient's vns device was originally implanted under the pectoral muscles and generator was in the armpit. In (b)(6) 2015, the leads had extruded out of the skin and the surgeon had gone in and moved the generator to a new location in the chest. He did not move the leads due to risk of damaging it and just routed the leads to the generator in the new location. However now, some of the leads is again extruding out of the skin in the old generator location. He suspects that the contractions of the pectoral muscles are what caused the leads to be pushed and extruded out for both times. The surgeon went back into the area of the extrusion and pushed the leads in further and cleaned out the area. Device was not even taken out of the body and no replacement of products took place. No visible infection was seen. Diagnostics performed afterwards showed everything was ok with 2611 ohms and ifi=no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5159327


Title: Re: Dehiscence
Post by: dennis100 on March 16, 2019, 01:51:29 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient presented to the physician's office with the vns chest incision red and "angry" looking, per the physician. It was stated at the time that there was no infection or drainage, but the incision was red and puffy looking. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. Follow up with the physician's office revealed that the wound site did not seem to be manipulated other than potentially by tension pulling at the incision site. It was stated that this was possibly from pulling at the patient's arm or lifting the patient under the shoulders. It was reported that the patient was very hyperactive and may have caused the separation from rough play. It was unclear if this was a report of the incision coming open. Removal of the vns was planned to preclude serious injury. Further follow up with the physician's office revealed that the incision had come open, but did not come completely open. The incision site was reported as infected, but the physician caught it in time and were able to treat the infection with antibiotics. It was reported that there was no surgical intervention, but the patient was admitted to the hospital where iv antibiotics were provided. The patient was then sent home on two weeks of antibiotics. The physician's office reported that they had seen the patient since and the patient was doing well. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7044768


Title: Re: Dehiscence
Post by: dennis100 on March 18, 2019, 02:14:18 AM
Model Number 304-20
Device Problems Low impedance; Component Missing ; Material Protrusion / Extrusion; Lead
Event Date 11/04/2015
Event Type  Malfunction   
Event Description
It was reported that a low impedance warning was received during diagnostic testing of a patient's generator. The patient had a bandage over his generator incision site. The patient underwent exploratory surgery to determine the cause of the low impedance. When the bandage was removed from the generator incision site, a portion of the lead was sticking out of the generator incision. Two surgeons spent 1. 5 hours searching for the rest of the lead, but they were unable to find it other than a small portion of one of the coils in the neck. There was an infection present at the generator site, so the surgeons decided to remove the generator and remaining portion of the lead that was attached to the generator. X-rays and ultrasound confirmed that no lead was present. The surgeons believed that the patient pulled the lead out of his body through the generator incision site. The device history record for the lead was reviewed, and the lead was sterilized prior to release. Attempts for further information regarding the infection were unsuccessful to date. The explanted generator and remaining portion of the lead have not been received to date. The patient has not had a new vns system implanted to date.
 
Event Description
Analysis was completed on the generator on 01/11/2016. The generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
The explanted generator and remaining portion of lead were received on 12/14/2015. Analysis on the lead was completed on 01/05/2016. The portion of the lead containing the manufacturing id tag was not returned, thus the model and the serial number of the returned lead portion could not be verified. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation could not 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. Analysis has not been completed on the generator to date.
 
Event Description
The cause of the infection was the patient picking at the incision site until it opened up and exposed the lead. It has been planned to replace the vns system in the future with the generator implanted on the patient's back. The patient has not had re-implant surgery to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5252502


Title: Re: Dehiscence
Post by: dennis100 on March 20, 2019, 11:05:33 AM
Model Number 304-20
Device Problems Extrusion; Lead
Event Date 10/09/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had inflammation and lead extrusion at the neck incision about six weeks after implant surgery. There was no indication of an infection. The physician did not know the cause of the inflammation or lead extrusion since the wound had been healing well after the implant surgery. On (b)(6) 2015, the lead was reinserted into the neck without the nerve and electrodes being touched during the procedure, and the incision was closed. The incision was reported to be healing well after the surgery.
 
Event Description
It was reported that an infection was present at the generator and lead sites on (b)(6) 2015. Infected skin necrosis on the left chest wall was found, and an open wound was visible with drainage. The generator and lead were explanted on (b)(6) 2015. The infection appeared spontaneously and was not attributed to patient manipulation. The physician plans to re-implant the patient with a new vns system in 3 months, because the patient responded well to therapy. The device history records for the generator and lead were reviewed, and both were sterilized prior to distribution. Attempts for additional information were unsuccessful to date.
 
Event Description
The physician believed that the cause of the infection was that the patient developed a seroma at the generator site 4 weeks post-op. Cultures were taken, and the result was staphylococcus aureus with multiple sensitivities (not (b)(6)).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5224608


Title: Re: Dehiscence
Post by: dennis100 on March 21, 2019, 01:18:43 AM
Model Number 106
Device Problem Human-Device Interface Problem
Event Date 10/07/2015
Event Type  Injury   
Event Description
It was originally reported by the physician the patient had a large infection at the generator site. The patient's lead and generator were explanted and the surgeon noted dehiscence caused by the patient smoking, and not infection. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The generator is expected to be returned for analysis; however, analysis is not relevant to the wound dehiscence as the dehiscence was reported to be due to the patient's smoking. Product analysis, if the generator is received, will be reported in mfr. Report # 1644487-2015-05824.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted lead was returned for analysis. It should be noted that only approximately 15cm of the lead was returned, not including the electrode array; therefore, an evaluation could not be performed on the entire lead. Setscrew marks were seen on the connector pin, providing evidence that, at one point in time, proper contact between the setscrew and the lead pin existed. Other than typical wear and explant related observations, no anomalies were identified in the returned portion of the lead. No other additional relevant information has been received to date.
 
Event Description
A vns implant card was received indicating the patient had been re-implanted with a new vns generator and lead on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5201164


Title: Re: Dehiscence
Post by: dennis100 on March 22, 2019, 02:17:22 AM
Model Number 106
Device Problem Insufficient Information
Event Date 12/02/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the neurologist the patient had an opening a little bit smaller than the size of a pencil eraser in her chest incision. It was noted it appeared that a stitch may have come out. The patient was sent to neurosurgery for further evaluation. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported by the physician the cause of the patient's small incision opening was due to patient picking. Daily bandages will not be kept on the patient to prevent access to the wound. The physician also noted the wound is well healed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5333113


Title: Re: Dehiscence
Post by: dennis100 on March 23, 2019, 01:17:00 AM
Model Number 106
Device Problem Insufficient Information
Event Date 10/09/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient needed to have his vns system removed, because the patient picked at his generator incision site until it opened unless he was under constant supervision beginning on (b)(4) 2015. An infection was present, and the physician had to give the patient multiple courses of antibiotics to treat the infection. However, the patient continued to pick at the site, and the infection would not clear. Therefore, the physician decided that the system would have to be removed. Device history records indicated that the devices were sterilized prior to distribution.
 
Event Description
The patient had vns system explant surgery on (b)(6) 2015 due to infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5312729


Title: Re: Dehiscence
Post by: dennis100 on March 24, 2019, 03:02:09 AM
Model Number 102
Device Problem Patient-Device Incompatibility
Event Date 06/30/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's vns implant surgery ((b)(6) 2015) incisions were not closing. Cultures were taken and there was no infection. Redness, granular tissue masses were reported as well, thought to be due to dead immune tissue in response to the open wound. The tissue was excised and irrigation of the site was also performed. The patient has been referred for device explant because the wounds will not stay closed. It is believed that the patient may have a metal allergy of some other foreign body response which is preventing proper healing of the incisions. No known surgical interventions have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the patient underwent vns explant surgery on (b)(6) 2015, and upon explant infection was noted. It was believed that the infection began in the patient's neck and spread to the patient's generator site. Cultures confirmed the infection was from staphylococcus. This patient's infection was previously reported in mfr. Report # 1644487-2015-06728 as the patient's identity was unknown at that time. Device history record sterility was reviewed and no non conformances were found. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5270831


Title: Re: Dehiscence
Post by: dennis100 on March 29, 2019, 08:19:00 AM
Model Number 106
Event Date 03/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Initially, it was reported that the patient developed an infection related to vns and that the physician was working on a plan. It was later reported that the site was not infected, but that the generator had poked through the incision. Further follow-up with the surgeon revealed that the generator was not extruding, but the incision was opening up. The surgeon indicated that he believed the scar retracted and caused the generator to push out with pressure from the way the patient sat in a wheelchair. The patient underwent revision surgery at which time the surgeon moved the generator further back into the pocket.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5542272


Title: Re: Dehiscence
Post by: dennis100 on April 04, 2019, 01:32:52 AM
Model Number 106
Event Date 05/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's vns incision was open. It is not known if this is relates to a previous report of tie-down extrusion and revision reported in medwatch 1644487-2015-05596. The site of the wound was not made apparent. The patient was reportedly seen by her surgeon, but the outcome is not known to the manufacturer. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Follow up with the surgeon's office indicated that the patient did not have an open vns incision at the time of her office visit. As an outcome of the appointment, no interventions were planned or taken. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5739981&pc=LYJ


Title: Re: Dehiscence
Post by: dennis100 on April 05, 2019, 01:36:48 AM
Model Number 304-20
Event Date 05/16/2016
Event Type  Injury   
Event Description
A report was received indicating that a patient's lead site incision had opened up and the implanted lead was exposed. Surgery to repair the incision was scheduled. Follow up with the provider indicated that on (b)(6) 2016 the provider successfully repaired the incision wound opening and was able to leave the implanted system intact; no devices were removed, explanted, or replaced. The patient has not returned for follow-up but the provider indicated they believe the patient is healing fine. The provider indicated the patient was seen in (b)(6) 2016 and there were no issues at that time. The cause of the lead extrusion is unknown per the provider.
 
Manufacturer Narrative
The manufacturer's initial mdr report inadvertently did not include the suspect device udi. The suspect udi should have been reported as (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5708741


Title: Re: Dehiscence
Post by: dennis100 on April 05, 2019, 09:55:37 PM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/22/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient had an incision and drainage procedure with chest would debridement. The vns generator site was infected with green drainage and wires and hardware from the vns were exposed. Device history records were reviewed for the generator. The device was sterilized and passed all specifications prior to distribution. The patient¿s infection was believed to be related to a previous infection, reported in mfr. Report 1644487-2018-01176. This infection is being reported separately as it occurred on a new generator. Information was received that the patient was continuing to reopen his wound. The patient had the sutures removed, and the wound had reopened. The patient was doing well and the site was clean with no drainage. The patient is on antibiotics. 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. No additional surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8449326


Title: Re: Dehiscence
Post by: dennis100 on April 05, 2019, 09:56:24 PM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Patient presented with an open wound with generator exposure on the patient¿s left side/chest. The wound was caused by a surgical site infection after device implant. The patient underwent a surgical procedure on (b)(6) 2019. The procedure was noted to be successful and the vns system remained in the patient¿s body with ok impedance. Further information was received that the patient had to go to the operation room to close the open wound and the patient has since been discharged from the hospital. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8458088


Title: Re: Dehiscence
Post by: dennis100 on April 06, 2019, 02:18:15 AM
Model Number 106
Device Problem Corroded
Event Date 02/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator explant due to their generator "eroding" at the site where the lead enters the generator, the header receptacle. The physician indicated that were was evidence of infection in the cervical and chest pockets and that the patient had wound dehiscence through his vns site. The patient was admitted to the hospital and given antibiotics. The patient's vns was removed, cultures were taken, and the infection was reported to have been cleaned out. It was reported that the vns site was "glued and looks great" and that the epileptologist requested to have the vns replacement placed in the patient's left axillae or left back. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications and was sterilized prior to distribution. The explanted suspect product has not been received to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387619


Title: Re: Dehiscence
Post by: dennis100 on April 07, 2019, 03:06:28 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's incision had opened and that there was pus draining from the open incision. It was also reported that the patient's generator was visible. It was reported by the neurologist's office that the physician was unable to assess what caused the extrusion as it could have been related to manipulation, the infection, or inadequate wound healing. The patient's generator was explanted and their leads were clipped due to the infection. 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 are 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=8439540


Title: Re: Dehiscence
Post by: dennis100 on April 07, 2019, 03:07:16 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/11/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient was having vns explanted due to incision on his chest breaking open, exposing the vns. The patient continues to pick at the incision site. The patient is autistic and requires 24 hour supervision. The physician plans to explant the lead as well due to risk of infection. The patient¿s vns generator was recently implanted. Device history record for the generator and lead showed that both devices were hp sterilized prior to distribution into the field. The devices were explanted. It was noted that the generator was exposed, system was removed, cultures were taken and revealed (b)(6) post-op and the patient was put on antibiotics. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8439742


Title: Re: Dehiscence
Post by: dennis100 on April 24, 2019, 02:15:12 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/03/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported by the neurologist that a young patient, who had been implanted earlier the previous month had been explanted due to infection. The neurologist believed it was related to the sterile field in the operation room. The manufacturer's device history records of the patient's lead and generator were reviewed. Sterility prior to distribution was verified. No further relevant information has been received to date.
 
Event Description
It was reported that in the pre-operative explant notes it was indicated that the patient had reportedly picked part of the generator site open. The surgeon's office indicated that surgery occurred after (b)(6) 2017 but that by (b)(6) 2017 both the lead and generator were removed and the sites were healing well. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6950577


Title: Re: Dehiscence
Post by: dennis100 on May 01, 2019, 12:58:26 AM
Model Number 302-20
Device Problems Fluid Leak; Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's generator incision had approximately a 1 cm opening. The patient was taken to surgery to where the incision cleaned and closed. The generator was left implanted. Review of the manufacturing records confirmed that the generator was sterilized and passed quality control inspection prior to distribution. It was noted that a few months prior to this report the generator had been repositioned due to infection. This event was reported in mfg report #1644487-2016-02673 however with the information available it does not appear that the current dehiscence wound is related to the previous infection. No additional relevant information has been received to date.
 
Event Description
It was reported that the generator pocket began filling up with fluid shortly after surgery that addressed the dehiscence wound. The fluid appeared to be building up behind the generator and the generator appeared to be "floating" in the pocket due the fluid. The patient was referred for surgery to drain the pocket and explant the generator. During the operation the surgeon observed that there was fluid inside the lead. Diagnostic testing was performed prior to surgery and there were no issues observed with the lead impedance. The surgeon was concerned that the fluid leaks in the lead could have been a contributing factor for the infection issues that were previously reported in this report and in mfg report #1644487-2016-02673. Manufacturing records were reviewed for the lead it was confirmed that the lead was sterilized prior to distribution. The lead and generator were both explanted at that time. Historically, the explanting facility does not return explanted products to manufacturers. Therefore product return is not expected. This report will continue to capture the fluid leaks in the lead and dehiscence wound events while g report #1644487-2016-02673 will capture the initial infection that occurred after the generator replacement surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6324817


Title: Re: Dehiscence
Post by: dennis100 on May 05, 2019, 01:06:01 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/24/2017
Event Type  Injury   
Event Description
It was reported that a few weeks following generator implant surgery the patient developed a dehiscence wound. It was noted that the wound was draining from a hole the size of a pin and the generator was protruding. The surgeon did not feel that there was an infection present however he felt it was best to refer the patient to surgery to have the generator replaced and to change the pocket to prevent an infection from developing. Manufacturing records for the generator were reviewed and confirmed that the generator was sterilized prior to distribution. The patient underwent surgery where the generator was replaced and the generator pocket was moved. The explanted generator was discarded following the surgery. Further follow-up found that the physician believed that patient manipulation and/or trauma contributed to the generator protruding and the dehiscence wound that had formed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6431341


Title: Re: Dehiscence
Post by: dennis100 on May 08, 2019, 10:31:52 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/06/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4). Device evaluation is not necessary because the reported infection is not related to vns therapy.
 
Event Description
It was initially reported the patient may have a potential infection that may result in vns removal. The surgeon explained that the patient's wound had split slightly at the chest incision site and they were optimistic it was external and at the suture closures, but the issue still didn't resolved. An additional antibiotic was prescribed. Later it was reported that the patient will have the vns removed due to infection. Clinic notes were received in regards to the referral for explant. Within the notes it was stated that after the patient's normal generator replacement, the patient developed a postoperative infection, which was treated with multiple antibiotics for several months. However, despite the patient being on antibiotics for several months, the wound continues to drain yellow fluid periodically and also swells up. Previously the patient had a fever, but he has not had the fever recently. The infection does appear painful. An attempt to cauterize the wound site did not stop the drainage of yellow pus. The patient's vns generator has since been explanted. Review of the device history record for both the lead and the generator confirmed sterilization prior to distribution.
 
Manufacturer Narrative
Operator of device, corrected data, initial report inadvertently selected incorrect device operator name and address, fax, #, corrected data, initial report inadvertently contained incorrectly-formatted fax number.
 
Event Description
The patient later underwent lead explant surgery due to continuation of the infection. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6521723


Title: Re: Dehiscence
Post by: dennis100 on May 08, 2019, 10:32:29 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2017
Event Type  Injury   
Event Description
It was reported that the patient's generator incision was starting to open and that patient was referred to see the surgeon. The surgeon cleaned the wound and re-stitched the incision. Follow up indicated that the neck incision and generator site looked good. Per clinical specialist, the incisions looked healed after the incision was re-stitched.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6374254


Title: Re: Dehiscence
Post by: dennis100 on May 09, 2019, 07:26:04 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2016
Event Type  Injury   
Event Description
The patient underwent a tracheostomy during a hospitalization for kidney stones. During the tracheostomy procedure the vns lead became exposed. The wound was left open and the medical staff was attempting to keep it covered. It was later reported that the wound was still open and the physician intended to take action to close the wound. However no surgical interventions were reported to occur at that time. Several months later it was reported that the patient was being referred for explant due to infection. No surgical interventions. A review of the manufacturing records for the lead and generator confirmed that both were sterilized prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported that the vns lead and generator were explanted to allow for the patient to recover from the infection. However the date of the surgery is not known. No additional relevant information has been received to date.
 
Event Description
It was reported that the wound closure surgery had never occurred because the patient was not deemed healthy enough to undergo a surgery where an already exposed implantable device was to be potentially retained. The physician believed that the exposed vns device led to the subsequent infection which led to the devices explant. It was noted that the infection was occurring along the implanted device and especially centered around the vns generator.
 
Manufacturer Narrative
Corrected data: evaluation codes; (b)(4). This information was inadvertently left off on mfg. Report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6520738


Title: Re: Dehiscence
Post by: dennis100 on May 10, 2019, 01:40:40 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient underwent a recent vns generator replacement, and it was reported that a possible abscess was observed on the patient¿s neck area close to the lead since the replacement. Additionally, two small openings in the chest wound were reported and the generator can be seen through the wound. The generator was later removed along with most of the lead. The manufacturing records for the lead and generator were reviewed and verified both devices were sterilized prior to distribution. The devices met all specifications for release prior to distribution. No additional, relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8566643


Title: Re: Dehiscence
Post by: dennis100 on May 11, 2019, 02:23:20 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/07/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device return and evaluation is not needed as the cause is oh.
 
Event Description
It was reported from clinic notes received that the patient has a small opening at their chest site and that the leads are exposed, and they are referred for site revision or lead explant. This patient's generator was explanted previously due to infection which is housed in mfr report # 1644487-2018-01342. The patient does have a history of picking at the site however it is not clear if this is the cause of the wound opening as the physician's office did not have a definitive answer for the cause. Device history records showed that the lead was sterilized prior to distribution. The patient's lead was explanted. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8475056


Title: Re: Dehiscence
Post by: dennis100 on May 11, 2019, 02:24:00 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an infection, which led to the removal of their vns generator and a wound debridement. The patient's neurologist indicated that the reason for the generator pocket infection was unknown. It was reported that prior to generator explant, the generator was visible, likely due to the infection per the physician, and that the patient had a history of wound dehiscence, generator migration, and erosion through the skin. The patient's leads were initially left and the patient was treated with iv antibiotics for 10 weeks. The patient was hospitalized due to worsening condition of the neck area, that had began to drain due to infection, and the lead was infected and extruding through the skin as well. The patient additionally had a red "pimple-sized" bump at their neck incision site where the lead was coming through. The patient then had their vns leads removed on (b)(6) 2018 due to the reported infection and foreign body response. The patient had discomfort at their neck due to the reported lead extrusion. The patient had their vns electrodes removed on (b)(6) 2019 due to the infection, foreign body response, and discomfort at neck caused by the presence of the electrodes. A review of the device history records verified that the implanted products were sterilized and passed all functional specifications prior to distribution. Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506142


Title: Re: Dehiscence
Post by: dennis100 on May 11, 2019, 02:24:35 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that when the patient went in to have their chest wound examined following vns implant surgery their wound had opened and there was bloody drainage observed. The patient was prescribed antibiotics. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8488466


Title: Re: Dehiscence
Post by: dennis100 on May 18, 2019, 01:11:05 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the event was not related to the performance of the device.
 
Event Description
It was reported by the surgeon's office the patient's vns generator pocket site had split open. The patient underwent explant surgery of both the lead and the generator due to the dehiscence and infection. Review of the device history records for the generator and the lead confirmed both devices had been sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6572351


Title: Re: Dehiscence
Post by: dennis100 on May 30, 2019, 06:23:15 AM
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/18/2017
Event Type  Injury   
Event Description
It was reported that a patient developed an infection at his generator site shortly after vns surgery. Antibiotics were administered when the infection first appeared, and the infection began to recede. No additional medical intervention was taken for the patient's infection. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
Progress notes from the patient's surgeon indicated that the patient experienced swelling at his generator site. Specimens were taken from the neck incision site and no infections were identified. The patient's generator incision site also had a slight wound opening of 2-3 mm. The patient reportedly had a massive keloid which the physician believed contributed to the patient's swelling and wound dehiscence. The patient was given antibiotics. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6610062


Title: Re: Dehiscence
Post by: dennis100 on May 30, 2019, 06:24:02 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/19/2017
Event Type  Injury   
Event Description
It was reported by a company representative that a patient was in surgery for irrigation and debridement of the incision site had opened. The reason the incision site had opened was unknown at the time. The surgeon opened the incision and washed it out and the put the generator back in. Diagnostics were then tested and the incision was then closed. The diagnostics were reported to be good. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Device evaluated by mfr? no. Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
Patient underwent complete vns removal due to infection. Device evaluation is not necessary as reported 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=6638804


Title: Re: Dehiscence
Post by: dennis100 on June 01, 2019, 03:43:19 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's chest incision had opened up and went to the emergency room. The neurosurgeon on duty provided antibiotics and applied several stitches to close the wound. The patient was seen by his surgeon, and it was planned to reposition the generator. The patient's generator and lead were explanted due to infection, and the surgeon believed that the patient had manipulated the device and caused the wound to open and the infection. The device history record of the generator was reviewed, and the device was sterilized prior to release.
 
Event Description
The physician confirmed that the infection was caused by the patient itching and manipulating the device. The device history record of the lead was reviewed, and the device was confirmed to be sterilized prior to release according to procedure. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6712521


Title: Re: Dehiscence
Post by: dennis100 on June 02, 2019, 07:09:59 AM
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2017
Event Type  Injury   
Event Description
Patient was scheduled for a full revision but instead underwent explant surgery due to infection. Patient had an open wound at the generator site with an infection. The explanted devices were discarded. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? na. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Notes from the explant surgery were received. The surgery was for left chest wound breakdown over the generator. The device had stopped working but no intervention was sought and no significant changes occurred. Patient however had a wound breakdown at the left side of the chest at the generator site. Patient was provided with antibiotics but the wound failed to heal. The generator was visible through he broken wounds, so it was decided to explore the wound via surgery. The generator was removed and 50% of the lead was removed. The surgeon also removed debriding necrotic material. Device return and evaluation is not necessary as reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6688353


Title: Re: Dehiscence
Post by: dennis100 on June 02, 2019, 07:10:34 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/23/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had dehiscence wound and infection that required vns explant and wound washout surgery. The patient had generator replacement surgery about two and a half months prior. The device history records of the generator and lead were reviewed, and both devices were sterilized according to procedure prior to release. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685454


Title: Re: Dehiscence
Post by: dennis100 on June 04, 2019, 08:04:04 AM
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient woke up the night after a vns surgery covered in blood because 2/3 of the incision had opened up. No other information was received regarding when this occurred, interventions that were taken, or the cause of the incision opening after surgery to date.
 
Event Description
Clinic notes were received from the day of surgery and report that "the estimated blood loss was about 65 cc. There was never any vigorous bleeding, but there was a very noticeable oozing of almost all of the would surfaces. Spent much of the total surgical time coagulating these small points. " no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6796984


Title: Re: Dehiscence
Post by: dennis100 on June 06, 2019, 02:26:19 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/03/2017
Event Type  Injury   
Event Description
It was reported that after a generator repositioning surgery the vns patient¿s chest incision from the surgery opened up on one side estimated to be ½ to ¾ inches. The patient went to an urgent care clinic and they noted redness and the opening and prescribed oral antibiotics. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Event description, corrected data: results of the dhr review were inadvertently not provided in the initial report.
 
Event Description
Review of the manufacturing records revealed the lead and generator were sterilized prior to distribution.
 
Event Description
Full revision surgery occurred.
 
Event Description
Follow-up from the surgeon indicated the cause of the migration was unknown and a suture securing the generator was not detected.
 
Manufacturer Narrative
Explant date, corrected data: the date of explant of the suspect device was inadvertently provided incorrectly on follow-up report #2. Event description, corrected data: details regarding migration of the device was inadvertently not provided on follow-up report #2. (b)(4).
 
Event Description
It was clarified by the treating provider that the repositioning surgery occurred because the generator was noted on x-rays taken to have fallen behind the patient¿s left breast.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6861945


Title: Re: Dehiscence
Post by: dennis100 on June 06, 2019, 02:27:00 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/09/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
A company representative reported that a patient was admitted to the hospital and subsequently had her generator explanted two months after initial implant surgery due to infection and generator extrusion. The infection and extrusion were caused by the patient rubbing and picking at her generator incision site. The explanting surgeon noted that there was no pus present in the pocket. Cultures performed at the surgeon's office confirmed the presence of an infection. The surgeon's office reportedly originally intended to prescribe infection medication for the patient; however, the patient soon returned to clinic with her generator extruding from her incision site, leading the physician to explant the device. The surgeon's office later reported that the patient's neck incision site was not healing well, and a noticeable protrusion of the leads at the neck incision site was also observed. A company representative clarified that the wound had opened and the lead was visible at the incision site. The representative stated the patient continued to pick at her wounds, causing the dehiscence wound and lead extrusion. The device history records for the lead and generator were reviewed and revealed that both devices met all specifications for sterilization prior to release. No additional relevant information has been received to date. No additional surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6874643


Title: Re: Dehiscence
Post by: dennis100 on June 07, 2019, 05:11:31 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/10/2019
Event Type  Injury   
Event Description
It was reported that the patient¿s chest incision had opened. The patient¿s device was recently implanted. It was stated the patient had a culture ran and was prescribed antibiotics. Device history records for both the generator and lead were reviewed and both devices were hp sterilized and passed all specifications prior to distribution. Per the physician, the believed cause of the chest incision opening was due to patient manipulation of the device. When asked if infection was confirmed the physician indicated ¿cx grew(?) skin flora¿ which appears to suggest that the cultures (cx) showed skin flora or skin microbiota referring to the microorganisms which reside on the skin. Many of them are bacteria of which there are around 1000 species upon human skin from nineteen phyla. They never confirmed that infection was seen just bacteria on the skin. The information also stated that no further interventions are planned. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8579149


Title: Re: Dehiscence
Post by: dennis100 on June 08, 2019, 05:41:32 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2019
Event Type  Injury   
Event Description
It was reported that the patient¿s incision was open. The patient presented in the hospital with dehiscence of the chest incision, and had surgery the next day for wound washout and re-closure. The patient¿s parents had noticed the chest incision had opened when giving him a bath. The patient was said to be fussier, indicating that he may have been in pain. At the previous appointment with the surgeon¿s office, the incision was said to be healing well. The physician did not have an assessment as to the cause of the wound opening. The device history records were reviewed for the generator and lead and the devices were sterilized prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8649403


Title: Re: Dehiscence
Post by: dennis100 on June 09, 2019, 01:04:51 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/26/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing numbness and pain under his arm following vns implant surgery. The patient was initially prescribed pain medication however this did not provide the patient any relief from the pain. It was later reported that the patient's neck and chest incisions from the surgery were not healing well. The patient was then taken to surgery for wound debridement and incision revision. Manufacturing records for the lead and generator were reviewed and confirmed that both devices were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
It was later reported that when the patient was having the wound healing issues the incision had opened and was infected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6853405


Title: Re: Dehiscence
Post by: dennis100 on June 11, 2019, 01:10:54 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/14/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported that the patient's incision site had come open and the patient had an infection. The patient was referred for surgery. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. Follow up with the company representative revealed that the vns generator site incision had opened and the vns lead was visible. It was reported that the patient underwent surgery. The surgeon cleaned up the infected area, then put the vns back in, and closed the patient. No additional relevant information has been received to date.
 
Event Description
The operative report from the previous vns generator replacement surgery were received by the manufacturer. The operative report indicated that the left chest was prepped and draped in sterile fashion. The previous vns generator incision site was open and the previous generator was disconnected from the vns lead and removed. The wound was irrigated. The new vns generator was connected to the vns leads and then placed back into the previous generator's pocket. The wound was closed with interrupted 2-0 vicryl and followed by a steri-strip closure of the skin. There were no complications reported.
 
Event Description
It was reported that the patient underwent vns explant surgery. Follow up with the surgeon's office revealed that the it look as if part of the patient's vns was sticking out of the patient's body like her body was rejecting it. The patient was reported to have continued drainage from both sites and had been on iv antibiotics. The vns was explanted due to the continued infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6966095


Title: Re: Dehiscence
Post by: dennis100 on June 12, 2019, 02:53:53 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient who was recently implanted has a golf ball sized lump over his generator. There is no redness or obvious signs of infection. The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder. The patient reported that the chest has become swollen like a golf ball. It is slightly warm to the touch, but not red. The patient saw the surgeon the surgeon decreased his output for the time being. It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep. The patient was advised not to bother the site and prescribed antibiotics. No additional relevant information has been received to date.
 
Event Description
Information was received indicating that the patient's lead came out of his neck incision. The physician's believe the patient has been picking at the site. It was indicated that the surgeon will be moving the patient's current vns system to his right side and checking lead integrity. The patient will also be placed on doxycycline for infection. Images were received that showed that the patient¿s lead is extruding out of his neck incision as well. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6958245


Title: Re: Dehiscence
Post by: dennis100 on June 12, 2019, 02:54:41 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/16/2017
Event Type  Injury   
Event Description
It was reported that the patient has an infection at both incision sites. The neurologist is putting patient on an antibiotic and the surgeon was notified of the patients situation. Additional information was received that the infection was clearing up and that the device is not being removed. No known surgical interventions have occurred to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.
 
Event Description
Patient was reported to have developed an infection again at the surgical site. The patient was asked to see the surgeon. No additional relevant information has been received.
 
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Patient reported that the device is still on and working but the generator and lead are "coming out of his chest". A few days later, an er physician and a general surgeon reported that the patient was in the er with a gaping wound and the vns device was out and swinging back and forth. The patient underwent removal surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6945466


Title: Re: Dehiscence
Post by: dennis100 on June 13, 2019, 03:20:35 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation not needed because the reported events have been determined as not related to vns therapy and stimulation. (b)(4).
 
Event Description
Report received that a patient's generator was exposed in the left chest. The patient was reportedly admitted to the hospital and put on antibiotics before the generator was to be explanted. Further information was received that the patient's neurologist believed an infection caused the generator to extrude from the skin, but the origin of the infection was reportedly unknown. Further information was received from operative notes that about a month prior to the extrusion, the patient presented with multiple erythematous areas over her neck and chest. It was noted that the patient's neurologist evaluated these bumps and determined they were related to insect bites. However, it appeared the patient did not recover with antibiotics and the generator began to extrude from the wound. It was not stated whether these insect bites led to the infection. The patient's mother reported that the site opened up and a gush of red tinged drainage was seen. The op-notes stated that during the explant, the generator was removed and the wound was cleaned. They also indicated that the surgeon removed some scar tissue in the generator area while performing the surgery. A review of the device history record indicated the generator had been properly sterilized to specifications prior to release for distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7047271


Title: Re: Dehiscence
Post by: dennis100 on June 21, 2019, 12:45:01 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/22/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported extrusion and infection are determined to not be related to vns therapy.
 
Event Description
It was reported that the patient's lead body was extruding out of the generator site which had occurred a few days before it was reported. The physician stated that it appeared that the patient had picked at the wound at the generator site since the wound had opened up and the lead exposed. The lead and generator were explanted and it was stated that the physician believed the site was infected. No antibiotics were prescribed to the patient for the infection. A review of the device manufacturing records showed that both the lead and generator were sterilized prior to distribution. The patient was referred for an additional surgery to remove the "anchor" which has worked its way out of the generator site and is exposed. No surgical intervention is known to have occurred to date.
 
Event Description
Additional information was received that the patient had an "anchor" that was removed due to it extruding at the neck incision site for the patient.
 
Manufacturer Narrative
Unique identifier (udi) # - corrected information: the udi number included on the initial manufacturing report was incorrect and was corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7202222


Title: Re: Dehiscence
Post by: dennis100 on June 22, 2019, 03:42:11 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/03/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that a patient had her vns generator explanted due to infection at the generator site. The infection was reported to have "eroded straight through to the battery pack". A device history review showed that both the generator and the lead were sterilized prior to distribution. As indicated through a follow-up with the surgeon's, the patient's generator was removed with no complications. The surgeon did not know the reason for the infection, but the nurse indicated that the patient is severely autistic and mentally and physically delayed. It was suspected that the infection may have been due to patient manipulation to the site, although this could not be confirmed. The patient's generator was implanted in 2016, so the reason for infection is not suspected to be due to implant surgery. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Udi #, corrected data: initial report inadvertently listed wrong udi/di number.
 
Event Description
It was later reported from the patient's neurologist that the patient's caregiver noted a "darkened area the size of a quarter" over the patient's vns generator site. The physician and neurosurgeon examined the darkened area and noted no fever, no drainage, and no signs of infection. The patient later went to the emergency room because the area over the generator had opened and the generator was visible. The device was explanted. System diagnostics were provided indicating no device failure. Follow up with the neurologist's office indicated that the suspected cause of the bruising and the incision site opening up was a pressure sore from the patient's chin that eventually opened up. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7205818


Title: Re: Dehiscence
Post by: dennis100 on June 23, 2019, 03:58:49 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
It was reported that the patient underwent vns generator explant surgery as the patient had picked at the incision site so much that the wound was open and the generator was exposed. It was reported that there was no infection and there was no plan for replacement at the time. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187826


Title: Re: Dehiscence
Post by: dennis100 on June 27, 2019, 12:05:09 PM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient with special needs had picked at the generator incision site causing it to open. The patient was prescribed antibiotics, and the generator was later explanted due to an infection. The device history record of the generator was reviewed, and it was sterilized prior to release. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7311348


Title: Re: Dehiscence
Post by: dennis100 on July 04, 2019, 01:05:03 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported that a vns patient has an infection at the generator site. Full explant surgery occurred. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the company representative provided the patient was picking at the wound site which is what caused it to re-open.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7666235


Title: Re: Dehiscence
Post by: dennis100 on July 14, 2019, 04:29:06 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that the surgeon is planning to perform a vns battery replacement with possible explant due to infection. Patient is delayed and kept picking at incision site and has picked it open and is now infected. The patient¿s generator was recently implant in (b)(6) 2018. While explant is likely, no known surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The generator was explanted and the lead was kept in and preserved. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7753035


Title: Re: Dehiscence
Post by: dennis100 on July 20, 2019, 10:45:39 PM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's vns was explanted due to infection. The patient was (b)(6) at the time she was implanted on (b)(6) 2017. After she was implanted, the generator was visible under the skin. In (b)(6) 2018, the patient's parents found a small crevasse at the generator site. The patient was provided anti-infection treatment, but the wound continued to expand until the generator was exposed. The generator was explanted on (b)(6) 2018 to let the site heal. However, the lead became infected as well and the surgeon explanted it on (b)(6) 2018. The patient's parent believed that the size of the generator and was too big for the patient. The manufacturer's device history records of the involved lead and generator was reviewed. Sterilization of the products was verified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939196


Title: Re: Dehiscence
Post by: dennis100 on July 26, 2019, 01:11:40 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that this patient had to have their vns generator explanted due to an infection in the generator pocket. It was stated that the patient was hospitalized. 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.
 
Event Description
Postoperative notes were received which stated that the reason for surgery was due to an infected vagal nerve stimulator battery with wound dehiscence and moderate inflammation. There was complex wound debridement and drainage. Complex would repair greater than 7cm. Information was received that the patient presented in the emergency department (ed) with wound breakdown and exposed hardware and the ed doctor expressed purulence at the initial evaluation. There was no evidence of neck tenderness or infection at the neck wound site. It was determined to keep the lead implanted while just removing the generator. It was stated that there was some necrotic tissue and the tissue bed was debrided back to good healthy tissue. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8280839


Title: Re: Dehiscence
Post by: dennis100 on July 30, 2019, 10:40:16 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2006
Event Type  Injury   
Event Description
A voluntary mdr report that was submitted 01/16/2019 was received to the manufacturer's. It was reported that in 2006 when the device was implanted, the patient began to have pain and 6 days later, the incision site opened, leaking blood and pus, with extrusion of the lead wire. The patient had the lead removed and 22 days later the device was reportedly "hanging outside the body" and the patient was readmitted to the hospital for surgery to remove the device. Then 3 months after, the patient noticed a 4-5' tube sticking out of the incision site that was draining large amounts of pus. The patient stated that she suffers from post-traumatic stress related to this case. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8389686


Title: Re: Dehiscence
Post by: dennis100 on August 10, 2019, 12:19:33 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/17/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported that the patient had a hematoma and an infection at the generator site following their generator replacement surgery. The incision site had reportedly opened up. It was reported that the patient continually rubbed the incision site. The patient was referred for generator explant. The device history records were reviewed for the generator and indicated that the product passed all quality tests and was sterilized per specifications. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8753583


Title: Re: Dehiscence
Post by: dennis100 on August 10, 2019, 12:20:19 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient who reported since last implant they have lost 30 lbs over the past 6 months. The device has migrated causing pain at the generator site. The generator is poking out and there is an area in the wound that is opening where the last stitch was located. The issue was noted in february and has gotten worse to the point where the wound in draining with blood. There was no infection reported nor a fever. The generator site was stated to be painful and purple/black. The patient does not think the device is protruding. The patient was informed by neurologist to see pcp before seeing surgeon. During follow-up it was stated that the patient was scheduled for revision surgery as there was a hole in their chest. Additional information was received from the surgeon that the cause of the migration, extrusion and dehiscence wound was patient manipulation. No non-absorbable sutures were used when the generator was implanted. Intervention is planned for the migration, extrusion and dehiscence wound to preclude infectious issues. It was stated that there was no relationship between the weight loss and vns. When asked what the believed cause of the bruising was it was stated none, therefore the cause is likely not known. No settings or diagnostics is known. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8823879


Title: Re: Dehiscence
Post by: dennis100 on August 10, 2019, 12:20:59 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported by the neurosurgeon that the patient presented with suture dehiscence at the electrode implant site. Upon re-examination, the surgeon indicated that according to medical report and physical examination there was no sign of an infection, which would also suggest a possible rejection. The device history record's of the lead was reviewed. The lead passed final quality and functional specifications prior to release. Additional information was received that the suture dehiscence meant the suture did not close up and the patient's skin was not weak. The wound had difficulty healing. It was stated that the physician attempted to perform an on-site clean-up and re-stitch but there was no success with this and that patient continued with poor healing. This led the patient to have the device removed due to suspicion of rejection of the device. The physician believes the patient presented rejection to some component of the device. After the explant, the site of the surgical wound was healing as expected. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8828642


Title: Re: Dehiscence
Post by: dennis100 on August 10, 2019, 12:21:41 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/09/2019
Event Type  Injury   
Event Description
Patient admitted to the hospital because he was picking at his neck incision site. The incision site was opened and the patient pulled the electrodes and anchor off of the nerve. It was noted that the patient is severely autistic. The patient underwent generator and lead explant surgery the following day. The explanted products were noted to be discarded. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8375680