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dennis100
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« on: January 24, 2019, 04:32:33 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
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dennis100
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« Reply #1 on: January 24, 2019, 04:33:20 AM »

Model Number 106
Device Problems Adverse Event Without Identified Device or Use Problem; Appropriate Term/Code Not Available
Event Date 06/23/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient was complaining of pain and numbness in the chest wall around the site of the generator. The physician believed that the patient's generator may have "loosened up". Clinic notes indicated that the patient had woken up and began to feel pain at the apex of the generator. He also felt numbness around the generator site that extended to the left side of his lower neck. The physician noted erythema at the left chest and neck. The physician believed that there may have been a dislodgement of the vns generator. The patient's system diagnostics were within normal levels with impedance at 2804 ohms. Approximately 6 months prior, the patient had had a physical alteration with his brother and his chest was hit, and the patient had been worried that the generator was damaged. Impedance was within normal limits. The patient was referred for replacement. On a fax from the physician, it appeared that the patient was referred for surgery to preclude a serious injury and for patient comfort. He indicated that trauma to the vns during the patient's fight with his brother was the believed cause of the migration. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
The patient reported that there was something wrong with his device. The patient said that his brother-in-law punched him in the chest where the device was which made the generator stick out. The physician reviewed the patient's x-rays and there appeared to be no lead breaks or issue with the generator. The surgeon ran system diagnostics on the patient's device while the patient was in many different positions and all were within normal limits. He also said that the patient's device hadn't migrated. 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=6753210
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dennis100
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« Reply #2 on: January 24, 2019, 04:34:19 AM »

Model Number 103
Event Date 07/01/2011
Event Type  Injury   
Event Description
It was initially reported that the pt had been hospitalized due to a possible auto-immune response to vns. Add'l info was received indicating that the pt has a medical history pre-vns of auto-immune disease. The exact response type is unk; however, it was related to the pt's nodules. The neurologist does not feel that the response was related to vns, however, as the pt recently underwent vns surgery, this cannot be ruled out. No add'l info is available to date.
 
Event Description
Follow up with the patient's treating neurologist indicated that all of the patient's reported symptoms were not related to vns. The device was explanted for patient comfort. The neurologist indicated that with vns, the patient's seizures were well controlled. Now, with the device explanted, the patient is still having seizures. The reported dysphasia, flushing and dizziness were not occurring with stimulation, and the patient has a medical history of dysphasia, flushing, and psychosis pre-vns. No diagnostics were performed, although the device was said to be programmed on. The neurologist also indicated that the patient's symptoms have not improved since the explant, as it was again reiterated that the patient's symptoms were not related to vns,.
 
Manufacturer Narrative
The initial report inadvertently did not include the product code.
 
Event Description
Additional information was received indicating that the patient was again hospitalized. The patient was experiencing a fever, trouble swallowing, dizziness, redness and heating around her device, and swelling of her left lymph nodes. The patient indicated that she would be following up with a surgeon to have the vns explanted. The patient believes that this is all related to an auto-immune response caused by the implanted device. The patient's vns devices were explanted on (b)(6) 2011. The devices have not been returned to the manufacturer for analysis. Attempts for additional information have been unsuccessful to date.
 
Event Description
The explanted generator and lead were returned to the manufacturer on (b)(6) 2011. Product analysis was completed for the returned generator. Results of diagnostic testing and monitoring indicated the device was operating properly. 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. Product analysis on the lead was also completed. Note that the electrodes were 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 measurements 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, and no discontinuities were identified. A slice mark was observed on the outer silicone tubing. The mark penetrated the insulation and appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. The inner silicone tubes did not appear to be damaged. 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 electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Additional information was also received on the return product form for the returned products. It was indicated that the lead and generator were explanted for adverse events such as psychosis, anxiety, and the auto-immune deficiency.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2220191
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dennis100
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« Reply #3 on: January 24, 2019, 04:35:01 AM »

Model Number 102R
Event Date 12/16/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
On (b)(6) 2013, a physician reported that a patient wasn¿t feeling well and had a fever. The patient was sent to the er and noted to have erythema from the generator site up to the neck and a fever of 102 degrees. The physician aspirated copious amounts of purulent fluid from the generator site. Cultures showed (b)(6). The patient was responding well to medications and antibiotics. The patient was to be monitored, and no other interventions were planned. The physician believed the infection was due to vns surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3579352
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dennis100
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« Reply #4 on: January 24, 2019, 04:35:56 AM »

Model Number 105
Device Problem Insufficient Information
Event Date 07/09/2015
Event Type  Injury   
Event Description
An image was received showing flushing and puffiness around the generator pocket incision site. Some puffiness was also visible around the neck incision site. Notes from the surgery were also received stating that the patient developed some redness near the incision and some drainage that appears to be infected. The surgeon found some serosanguineous fluid , which was cultured and then removed the generator from pocket. The surgeon also removed the lead and was able to dissect the lead but noted that there was significant amount of scarring and inflammation in the sternoclaoimastoid muscle.
 
Manufacturer Narrative
Describe event or problem, corrected data: per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015. This information was inadvertently left out of the previously submitted emdrs.
 
Event Description
Additional information was received that the patient is still fighting (b)(6) infection and that the physician recommended explant of the lead, which was not previously removed. The initial infection was reported to have started about a week after implant.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
Per notes dated (b)(6) 2015, patient was picking at the well healed site and managed to expose of the lead wires. A second surgery to remove the remaining portion of the device was performed as a result on (b)(6) 2015.
 
Event Description
It was reported that the patient acquired an infection, which was first observed by the physician on (b)(6) 2015. The infection was reported to have started in the chest incision and followed the lead up to the neck site. Patient underwent explant of vns system on (b)(6) 2015 as planned. No patient involvement was suspected. A culture was taken but the results were not available. Review of manufacturing records confirmed that both the generator and lead were sterilized prior to distribution.
 
Event Description
Patient underwent lead removal surgery on (b)(6) 2016 and the surgeon removed the two electrode sets and the anchor tether. During the surgery, the surgeon noted that there was evidence of left vagus nerve injury that resulted in hoarseness and coughing. The surgeon's impression was that someone pulled the lead thinking that the electrodes will unwrap themselves. Per the surgeon, the patient had seen a ent a few weeks ago and received an implant in the left vocal cord to get the vagus nerve to more approximate normal location.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5001435
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dennis100
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« Reply #5 on: January 24, 2019, 04:36:57 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
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dennis100
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« Reply #6 on: January 24, 2019, 04:39:07 AM »

Model Number 103
Event Date 06/01/2013
Event Type  Injury   
Event Description
It was reported that the patient underwent vns explant on (b)(6) 2014. A new vns system was not implanted. The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 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. Analysis of the lead is underway, but has not been completed to date.
 
Event Description
On (b)(6) 2013, it was reported that the flushing occurs when the magnet is used to abort a seizure. The flushing does not occur when the magnet is used prophylactically.
 
Event Description
Lead analysis was approved on (b)(4) 2014. An analysis was performed on the returned lead portions. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this patient was seen for his first vns dosing after implant and was programmed on. The patient did well with dosing with no side effects; however, the patient¿s mother reported on (b)(6) 2013 that when the magnet was used, there was a red flushing along the generator site and the left neck lead site. This was not painful or bothersome, and there were no complaints from the patient. The patient did not use any new topical lotions, and there are no other reported contributory events that could lead to redness and flushing. It was unknown how long it took for the ¿flushing¿ to resolve. The patient¿s mother also reported that the patient had a seizure on (b)(6) 2013. When the magnet was used, the place of vns implant and under his chin turned red and splotchy. The patient was wearing a shirt, and the skin was not touched. The patient was referred back to the surgeon for check. Follow-up with the surgeon showed that the patient was last seen on (b)(6) 2013 at which time the wound site was healing nicely with no evidence of erythema or infection. No interventions were to be taken for the flushing other than monitoring. From the surgeon¿s perspective, everything was normal. When asked if there was a pre-existing condition that may have led to the flushing, it was stated that prior to this, there was some opening of the left axillary incision site after the sutures were removed. This was resolved by using glue. There were no other conditions, pre-existing or otherwise, that would have caused the flushing. There was no known manipulation.
 
Event Description
Additional information was received that the patient had their generator turned off to see if the flushing resolves or changes. The mother contacted the manufacturer and reported that the patient was going to see an allergist to determine if the patient may be allergic to any of the components in the generator or lead.
 
Event Description
It was reported that a video was received that showed the flushing starting above the generator and arching toward the central line on the patient's neck about 20 seconds into the video. It was reported that the patient experienced two seizures the day of the video and that the flushing occurred with one, but not the other. After observing the patient's seizures it was determined that the flushing was never a reaction that the patient actually had. It was reported that the neurologist feels like the generator could be disconnected in some way from the lead causing a lead; therefore, causing flushing around the generator header. X-rays were performed and sent to manufacturer for review. Based on the x-rays, the cause for the patient¿s flushing is unknown. It was later reported that the patient was seen for follow-up and was doing good. Device diagnostics were within normal limits. The physician decreased the device output current to see if the flushing resolves. It was reported that the patient is now getting red in the face during seizures and very hot, but that the patient has been diagnosed with anhidrosis (inability to sweat) at a very young age. The physician is beginning to question if the flushing is related to the patient's anhidrosis diagnosis.
 
Event Description
On (b)(6) 2014, it was reported that the patient had not experienced further flushing.
 
Event Description
It was reported that the patient was seen by a surgeon who wanted to "watch it". The patient's mother reported that there is redness around the generator pocket and the generator is prominent and looks like it is pushing through the skin. The patient will return to surgeon in a few days for recheck. It was also reported that the patient's mother was not satisfied so she is going to take the patient to a second physician. It was later reported that the second physician is sending the patient for vns explant. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3215696
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dennis100
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« Reply #7 on: January 24, 2019, 04:40:12 AM »

Model Number 103
Event Date 06/08/2012
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
On (b)(6), 2012, this vns patient reported that she was implanted on (b)(6), 2012. The patient was implanted in (b)(6) and remained there for two days post operatively for an incision check, at which time she was well. One day after returning to (b)(6), the patient began to feel ill and was taken to the emergency room. The patient was admitted for pneumonia and incision infection. The patient stated that she spent two days in the hospital and received multiple antibiotics. When the patient reported this event on (b)(6), 2012, she stated that she was back at home, that she was feeling better, and that the incisions were looking better. On (b)(4), 2012, manufacturer records were reviewed. It was confirmed that both the generator and lead were sterilized prior to distribution. On (b)(6), 2012, follow up with the admitting hospital revealed that the patient had been admitted on (b)(6), 2012 and discharged on (b)(6), 2012. Attempts for additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2012, follow up with the admitting hospital's director of infection was performed. The director obtained information from the patient's charts and stated that the patient was admitted on (b)(6) 2012. The patient came in with pneumonia and erythema at both the neck and chest incision sites. The patient was given antibiotics and intravenous fluids. Blood cultures were taken with negative results. The patient was diagnosed with left neck surgical wound infection and sepsis. The patient returned on (b)(6) 2012. Dehiscence was seen; however, no interventions were taken as the incision appeared to be healing well. The relation of the pneumonia to vns was unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2646272
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dennis100
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« Reply #8 on: January 24, 2019, 04:41:07 AM »

Model Number 302-30
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported that a patient wanted to have the vns device removed due to lack of efficacy. The patient was later seen by a surgeon who noted that the lead appeared to be protruding. Follow up with the surgeon revealed that the retention clip (tie down) on the sternocleidomastoid muscle at the anterior loop of the electrode wire is causing pressure type irritation and appeared to be near extrusion. There was a thinning of the skin and an erythematous nodule overlying the clip. This may be secondary to the patient's habitus - as the patient has a low body fat percentage thus leading to less tissue between the clip and skin. There was no patient manipulation or trauma. The patient's weight has remained stable and has no other systemic disease that would explain any decrease in tissue integrity. The lead and generator were later explanted and not replaced. Good faith attempts to obtain the explanted lead and generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1847770
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dennis100
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« Reply #9 on: January 24, 2019, 04:42:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/02/2017
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
The patient was seen by his primary care physician due to concerns of a possible infection. The primary care physician noted that the patient had keloid formation, purulence, pain, warmth, and erythema all present in the chest area or at the generator incision site. The physician believed that the infection was caused by the patient's severe case of chest acne, which was incredibly active around the generator incision site. The combination of the bacteria from the acne and the incision site led to the possible infection, according to the physician. The patient was later referred to his implanting surgeon for follow-up. The patient was seen by his implanting surgeon. The patient reportedly had an abscess at his generator incision site, according to the surgeon. Cultures were taken and confirmed the presence of the infection. The patient was told to continue taking his antibiotic medication, which appeared to be related to his acne. The patient was seen one week later by the surgeon, and the infection at the incision site began to heal. No additional intervention was taken for the patient's infection. The device history records for the lead and generator confirmed that the devices met all sterilization specifications prior to distribution. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6672229
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dennis100
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« Reply #10 on: January 24, 2019, 04:43:03 AM »

Model Number 101
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Notes dated (b)(6) 2013 indicated that the patient may have had a seizure on (b)(6) 2013. The device was interrogated at 1. 75/20/130/30/5/1. 75/30. The impedance was ok (dcdc=3), the output status was ok, and the battery was noted to be functioning well. Notes dated (b)(6) 2013 indicated that the patient presented with a 2 year history of voice changes and hoarseness. The patient did not experienced any hoarseness following vns implant, except when it fires. A flexible videostroboscopy was performed with mild atrophy and supraglottic contraction but otherwise normal results. The event was determined to be muscle tension dysphonia for which the patient was referred for speech therapy. Clinic notes dated (b)(6) 2013 stated that the patient felt that her device was no longer working. The patient had three grandma seizures during the year. Prior to that, the patient had not had any seizures in 12 years. The patient also noted that her voice felt weak at times and thought the events might be related. A flexible laryngoscopy was performed: bot, vallecula, and piriform sinuses were clear and normal. Both true vocal cords showed good mobility, but there was possible slight bowing with a 1 mm gap. Moderate arytenoid erythema and mild edema were present. It was reported that the patient has possible mild age related atrophy and mild laryngitis contributing to her voice changes. The patient was referred for generator revision. The vns generator replacement was performed on (b)(6) 2014. The explanted vns device was discarded and therefore cannot be returned. Attempts are being made for additional information; however, no other information has been provided.
 
Event Description
It was reported that the generator battery was dying and the patient experienced more seizures. The physician reported that the patient is doing much better since generator replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606821
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« Reply #11 on: January 24, 2019, 04:44:05 AM »

Model Number 103
Event Date 07/09/2014
Event Type  Injury   
Event Description
It was reported that the infection resolved and the patient is doing well without vns. At this point, the patient's mother has no intentions of having a new vns system implanted.
 
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 increased seizures were not changed in comparison to pre-vns seizure frequency levels. It was further reported that the initial implant surgery used a permanent suture. During explant surgery, the entire lead was removed from the pocket including electrodes from the nerve. The patient is severely disabled; the physician suspects that she manipulated the vns device and incision obsessively, and thereby, causing the generator migration and protrusion.
 
Event Description
It was reported that the recently implanted vns patient developed an infection. The patient¿s incision site was washed out and the patient was admitted to the hospital of iv antibiotics. Clinic notes were received indicating that the patient did not present with any postoperative complications during an office visit on (b)(6) 2014. The patient was seen again on (b)(6) 2014 due to concerns regarding the patient¿s surgical incision site. It was reported that the patient¿s generator had become out of position as it was seen protruding more when the patient was lying on her side vs. Standing or lying flat. The notes indicate that the patient¿s generator may have been displaced during to patient manipulation or movement but was functioning properly. Additionally, the patient had been experiencing an increase in seizures. The patient¿s device output current was subsequently increased. No signs of infection were observed during the office visit on (b)(6) 2014. The patient¿s incisions site was noted as healing well. The notes indicate that during an office visit on (b)(6) 2014, the patient had redness and tenderness at her incision site. The patient had been more lethargic than normal and also had a fever of 100°f the day before the office visit. The patient was given antibiotics and referred for surgery to clean and drain her incision site. Operative notes indicate that the patient underwent surgery on (b)(6) 2014 due to obvious infection and erythema at the incision site. There was no active drainage. Upon reopening the incision site, pus was observed surrounding the subcutaneous pocket surround the patient¿s generator. The patient¿s generator was explanted and cleaned with antibiotics. The patient¿s incision site was washed out with antibiotics and the generator was re-implanted. Cultures were positive for staph. Aureus. Follow-up revealed that the surgeon later elected to remove the patient¿s generator and lead. The patient was placed on an antibiotic regimen and is expected to be re-implanted. The patient has not been re-implanted to date. It was noted that the patient¿s increase in seizures was back to pre-vns baseline levels.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4035190
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« Reply #12 on: January 24, 2019, 04:44:52 AM »

Model Number 304-20
Event Date 03/24/2014
Event Type  Injury   
Event Description
Analysis of the returned generator was completed. Results of diagnostic testing indicated the device operated 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.
 
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¿s incision sites were red and swollen about 2-4 weeks after implant surgery so the patient was given an antibiotic regiment. The patient¿s lead was reported to be extruding from her neck. It was noted that the patient may have been picking at her neck incision site following implant surgery. Clinic notes were received indicating that the patient had a grand mal seizure that lasted several minutes and subsequently caused her lead the extrude from the left side of her neck. The patient went to the emergency room on (b)(6) 2014 and was admitted to the hospital due to lead extrusion. The patient did not have a fever or any neck swelling. There was no change in the patient¿s seizure frequency. The lead was observed to be extruding from the neck incision site with minimal erythema. The patient¿s chest had a puffy area that was fluctuant but not especially erythematous with no surrounding induration. The surgeon stated that it was most consistent with a seroma with a possible foreign body reaction. The patient underwent surgery on (b)(6) 2014 to explant her generator and revise the lead. Operative notes indicate that there was a mass of inflammatory tissue in the chest wall upon opening the epithelium. An exuberant amount of inflammatory tissue was observed around the patient¿s generator. No abscess was encountered. Other than granulation tissue in the left neck, the lead incision site looked normal and without any sign of infection. A portion of an electrode and a tie-down were observed to be extruding from the neck. The tie-down was removed from the lead. The patient¿s device was tested and diagnostic results revealed lead impedance within normal limits. The inflammatory tissue in the chest wall was removed and the patient¿s generator was explanted. The surgeon explanted the generator because he felt it was too big to be sterilized in the contaminated generator site. The generator pocket was debrided and rinsed with an antibiotic solution. The neck incision was then reopened and the granulation tissue was removed. The surgeon pulled down the disconnected lead in the chest wall and was able to reposition the lead into the deep intramuscular tissues in the neck. The neck incision site was irrigated and then closed. Antibiotic ointment was applied to the neck incision site. The lead was secured in the chest wall with sutures and the chest incision was closed. The patient was given a postoperative antibiotic regiment. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that the patient had another surgery about three months after the generator explant to have her leads explanted due to foreign body reaction in the left neck and upper left chest. The surgeon removed an inflammatory mass of in the left chest cavity (4cm). No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3827886
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« Reply #13 on: January 24, 2019, 04:45:56 AM »

Model Number 103
Event Date 05/05/2012
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The generator was confirmed to be at ifi=yes. The data in the diagaccumconsumed memory locations revealed that 119. 305% of the battery had been consumed. The battery, 2. 679 volts as measured during completion of the final electrical test, suggests an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the explanted generator was returned for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information was received on (b)(6) 2012, when the nurse practitioner reported that the increased seizures were first observed on (b)(6) 2012. The nurse stated that the increase in seizures was due to the generator nearing end of service, but that the patient also had intercurrent macular erythematous rash that possibly exacerbated it. The patient has been referred for battery replacement. The patient's change in seizure pattern (seizure for 3 consecutive days) was reported to be possibly due to vns. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the change in seizure pattern. Attempts were made for return of the explanted generator but it has not been received for product analysis to date. Good faith attempts were made to the implanting hospital for the patient's lead product information and were successful.
 
Event Description
On (b)(6) 2012 clinic notes were received from a vns treating nurse practitioner (np). Review of the clinic notes dated (b)(6) 2012 reveal that since the patient's last clinic visit on (b)(6) 2012 the patient had stable seizure control until about two weeks prior when she had a flurry of increased seizures and was hospitalized for several days. The patient had a rash over her entire body at that time, but otherwise had no signs of illness. The patient's zonegran was increased to the current dose during that hospitalization. The patient has not had any seizure since discharge from the hospital. Prior to this flurry of seizures the patient had an average of 2-3 seizures/month which is her baseline. These seizures typically have a catamenial pattern an area of the same semiology described as feeling nauseated, then eyelid fluttering, head turning usually to the left but sometimes to the right, then tonic followed by clonic activity of either arm, both arms, or both legs. Duration is typically 1 minute. All the seizures occur just as she is going to sleep. The patient's vns settings are output=1. 5ma/on time=30sec/off time1. 8min/pulse width=500usec/frequency=30hz/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=500usec and the patient was noted to be tolerating it without adverse effects. The vns is nearing eos and the patient was referred for replacement surgery. A system diagnostics test was performed which showed 2467ohms/ifi=yes and the device to be functioning properly. The rash was noted to be nearly resolved. The patient's mother feels that the vns has been very efficacious; prior to implant the patient had daily seizures. Clinic notes dated (b)(6) 2012 were also received. The patient had fairly stable seizure control although she had one seizure for 3 consecutive days the past weekend which was unusual for the patient. The patient was noted to typically have an average of 1-2 seizure every 2 weeks associated with ovulation and her menses; otherwise, she is seizure free. A system diagnostics test showed the patient's device to be functioning properly with impedance value=2408ohms/ifi=yes. The np stated that the increased seizures this past weekend may be due to the gradual depletion of the generator. Per diagnostic testing the patient continues to have more than 6 month battery life remaining, but close monitoring is recommended. Attempts for further information from the nurse practitioner have been made but have been unsuccessful to date. The patient underwent generator replacement on (b)(6) 2012. Attempts for product return are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2744864
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« Reply #14 on: January 24, 2019, 04:46:50 AM »

Model Number 102R
Event Date 05/20/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient developed swelling and erythema in the area of the generator. It appears to be directly related to the device and the erythema extends below the swelling towards the patient's left nipple and laterally towards the axilla. The patient was prescribed antibiotics and exploratory surgery was considered. Further follow-up revealed that explant surgery was planned, but it was reported that if the infection resolves by the next visit the device will not be removed. It was later reported that the site was much less swollen and inflamed and that the patient has responded well to the antibiotics. The explant surgery was cancelled and the patient was given an additional week of antibiotics.

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« Reply #15 on: January 24, 2019, 04:47:54 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3165711
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« Reply #16 on: January 24, 2019, 04:48:54 AM »

Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful. Surgery is still likely, but has not occurred.
 
Event Description
On (b)(6) 2012, a surgeon's office reported that they had received a phone call from a patient's mother. The mother reported that the vns patient had been experiencing continual hoarseness, choking, blue lips, face redness, vomiting, and inflammation at the surgical site. The patient's mother stated that the device was turned on at the date of surgery. At first, the patient's coughing was mild; however, as the day progressed, the coughing and choking became worse. She reported that the patient was feeling anxiety and, as a result, pacing due to the side effects. She also stated that the patient feels "like her head is going to explode. " the mother also reported that the patient has not had a grand mal seizure in two years; however, she has had two grand mal seizures since implant and went to the emergency room. (the date of the hospital visit is unknown. ) the patient went in to see her neurologist and the settings were decreased; however, the symptoms continued. The patient returned to the neurologist on (b)(6) 2012 and the device was disabled; however, the magnet output current was intentionally not programmed to 0 ma, and the patient and mother were told to swipe the magnet if they felt a seizure coming on. On (b)(6) 2012, a physician's office reported that they had spoken to the patient's mother on this date. The mother reported that the neck incision was swollen (there was a somewhat hard bump there that hurt when touched). She also stated that each time the device stimulated, the patient felt like she was being choked, turned red, the lips turned blue, and she would vomit. When the patient spoke, the mother noticed that the nerves were "pulling at her upper lip. " on (b)(6) 2012, a voicemail was received from the neurologist. He stated that he saw the patient and disabled the output current, expect for magnet stimulation. The physician stated that the patient was problematic and could not tell if the patient had a lot of anxiety or if the events were actually occurring. He stated that the patient reported choking; however, he did not see this and thought her swallowing was normal. He also stated that the patient reported tightness in her throat and coughing. In addition, he stated that there is a little swelling at the neck incision that was typical for surgery and not alarming. On (b)(6) 2012, the neurologist reported the patient's wounds were fine; however the patient was very anxious about the device and wanted it removed. The neurologist suggested using vitamin e cream for the wounds and giving the healing process a chance. The neurologist believed that the device was still programmed to only deliver magnet stimulation. The neurologist also believed that it would be best to leave the device in for a few months, especially after wound healing. On (b)(6) 2012, a surgeon's office reported that the patient's anxiety made the mother become anxious and any little pin prick sensation caused them to call everywhere. Surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2638613
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« Reply #17 on: January 24, 2019, 04:49:53 AM »

Model Number 10X
Event Date 01/01/2001
Event Type  Injury   
Event Description
It was initially reported in the article titled "vagal nerve stimulator infection: a lead-salvage protocol" that there 6 patients that had infections after being implanted with vns. Follow-up with the physician indicated that he would not be providing any additional information. He was not willing to go back through the data to determine who the patients were and felt that all adverse events would have already been reported this medical device reporting (mdr) report is for patient 5. The infection occurred after the patient¿s initial implant. The patient presented 8 weeks post-operative with erythema and edema at the generator incision site. The patient had the associated presenting symptom of fever. Cultures were taken and showed (b)(6) and p. Mirabilis. The patient was treated with cefazolin intravenously (200 mg every 8 hour) for 21 days. The lead salvage procedure was not successful and the patient had to have a total removal and was re-implanted at a later date.
 
Manufacturer Narrative

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2829344
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« Reply #18 on: January 24, 2019, 04:50:43 AM »

Model Number 105
Event Date 04/10/2013
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
Additional information was received that the patient had elective generator replacement that was complicated by a post-operative wound infection. Another physician attempted in situ treatment of the infection. The infection was at the generator site, but the whole system was removed due to chronic infection. Cultures were taken but returned negative as the patient had been on a long term antibiotic. No patient manipulation or trauma occurred that is believed to have caused/contributed to the infection.
 
Event Description
On (b)(4) 2013, it was reported that this vns patient had an infection at the surgical site along with generator extrusion. The patient was to be kept on antibiotics for several weeks. Clinic notes from (b)(6) 2013 indicated that the patient was having more brief seizures but the clusters were not lasting as long. The patient had an infection at this time in the pocket that was being treated with antibiotics. No changes were made to settings. The patient also presented with an infected suture line with some purulent drainage that improved on antibiotics with some redness. The site was cleaned on this date. Notes from (b)(6) 2013 indicated that there was progressive opening of the wound such that the generator could be seen. It was believed that the patient's brace may have put pressure on the incision and continued to breakdown of the wound and/or wound infection. Follow-up showed that the patient was previously seen on (b)(6) 2013, and the patient's seizures had not significantly improved because the patient was not up to his previous settings. The increase in seizures from (b)(6) 2013 was believed to be related to the lower settings, but the relation to baseline was unknown. Additional follow-up showed that cultures returned negative because the patient was treated at different facility with antibiotics. There was no known patient manipulation or trauma that is believed to have caused/contributed to the infection. The infection was at the generator site with no visible infection at the lead site. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Lead and generator explant occurred on (b)(6) 2013, and the devices were returned on (b)(6) 2013. Generator product analysis concluded that the device was operating properly. Electrical tests showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Lead analysis was performed: what appeared to be white deposits were observed on inner silicone tubing. Energy dispersion spectroscopy was performed and identified the deposit as containing silicon, phosphorus and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3112828
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« Reply #19 on: January 24, 2019, 04:51:44 AM »

Model Number 102R
Event Date 10/09/2012
Event Type  Injury   
Event Description
Additional information was received from the patient's surgeons office in regards to culture results in the patient's vns generator pocket. Rare white blood cells, no bacteria seen.
 
Manufacturer Narrative
This information was inadvertently left off of mfr. Report #3.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization prior to shipment of their generator.
 
Event Description
It was reported by a vns implanting surgeon that his patient was in hospital with an infection at the generator site. The patient recently had a battery replacement for end of battery life on (b)(6) 2012. On (b)(6) 2012 - the mother reported that her child was fine and no sign of any problems. Somewhere in between tuesday and friday, he began to lose appetite, get sick, developed a low-grade fever, then had redness and swelling at incision site. No report of any draining or bleeding. He was taken to the emergency room and given iv antibiotics and then po clindamycin. The patient was then told to return to ent surgeon first thing (b)(6). On (b)(6), it was reported that the patient was doing better now, has increased appetite and the fever is down. The incision is healed and intact, however, there is still redness and swelling - a fluid-like feeling around the incision. The surgeon reported that he recalls a hard calcification during surgery that had formed around first generator and he removed it during the replacement procedure. He feels some fluid may have accumulated and gotten infected. They did take blood cultures. He planed to admit the patient into the hospital for a couple of days and administer iv antibiotics. (b)(6) the surgeon reported patient is overall a 'lot' better, fever is gone, skin has cleared except for a slight pinkish color localized to generator. Fluid collection is down and he can feel the generator. The surgeon was keeping the patient in hospital on iv antibiotics until 18th, then releasing on antibiotics po. The surgeon planned to aspirate fluid collection around the generator in a week, unless the patient worsened. If patient's infection worsened, he would explant their generator and attempt to salvage the lead. The surgeon is attributing the event to surgery - in particular, the result of the removal of hard calcification that had formed around the generator. He feels that may have left the tissue raw, and caused fluid to collect. He didn't feel it was due to any interaction from the patient. The patient's generator extruded and it was explanted on (b)(6) 2012. Good faith attempts are underway to obtain culture results.
 
Event Description
The lead was explanted and replaced on (b)(6) 2013.
 
Event Description
It was reported that prior to lead replacement and generator implant surgery the patient's wbc count was "a little elevated". The patient had a temperature of 100. 4 degrees following the surgery at 10pm and then by 3am the temperature was 104. 2 degrees. It was reported that the fever broke between 3 am and 6 am that morning.
 
Event Description
Clinic notes dated (b)(6) 2012 were received which summarize the reported infection event. On the patient's last visit to vns battery was dead. Patient had been vns generator battery replaced on (b)(6) 2012, that got infected seen and er at enterprise treated with clindamycin developed cellulitis and subsequently had incision break down and had the procedure done for removal of the vns generator. The notes state that the patient came in on this day for a follow up after having the vns stimulator removed. Two weeks after the patient had a battery implant, he had developed a severe infection for which he was placed on vancomycin iv from (b)(6) 2013 to (b)(6) 2013. This infection progressed to the degree that he could not lift his arm. This continued to progress to the point that the suture line ruptured and the entire stimulator pushed out of his skin. He ended up having it removed on (b)(6) 2013 and stayed in the hospital until (b)(6). He has completed a course of two weeks of clindamycin after being hospitalized and he is no longer on abx. Since the surgery, he initially had an increase in seizure activity but that has decreased to his baseline levels. He continues to have one to two of his more severe seizures per week with other petit seizures interspersed. His lead remain in place at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2822202
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« Reply #20 on: January 24, 2019, 04:52:33 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253
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« Reply #21 on: January 24, 2019, 04:53:36 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
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« Reply #22 on: January 24, 2019, 04:54:29 AM »

Event Date 06/04/2013
Event Type  Injury   
Event Description
On (b)(4) 2013 information was received from the reporter stating that the physician was concerned about redness and swelling around the patient¿s chest incision for her recent generator and lead replacement surgery. Follow up with the patient¿s mother determined that the patient was taken to the local er on (b)(6) 2013, where she then admitted to the hospital to aspirate liquid, which was whitish in color mixed with blood, from the chest site. The physician informed the patient¿s mother he did not think it was an infection, but that to prevent it from becoming an infection that the patient would start receiving iv antibiotics. Further follow-up on (b)(6) 2013 determined that the patient was still in the hospital and that her neck lead incision site had been tapped and that a clear liquid with tinges of blood was aspirated. The physician feels that the site was a seroma. A ct scan was performed, showing a large pocket of fluid collection, which was suspicious for potential abscess formation. The patient was taken to the or on (b)(6) 2013 to receive wound washout and picc placement for wound infection. After, the patient was released and placed on iv antibiotics for 6 weeks. Attempts for additional information will remain ongoing.
 
Manufacturer Narrative

Event Description
It was reported that patient consent would be needed to release any information regarding the patient.

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« Reply #23 on: January 24, 2019, 04:55:05 AM »

Model Number 302-20
Event Date 01/14/2009
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 following lead revision surgery, a vns patient began experiencing neck pain when turning her neck from the left to right and upon tilting her chin back. During the surgery, the lead has been dropped on the floor. The surgeon soaked the lead in betadine and rinsed it off prior to implanting the lead in the patient. The vns device had not been programmed on after the surgery. There was some redness and swelling at the neck incision site which resolved with antibiotics. However, the patient continued to experience neck pain. The surgeon indicated there was no infection at that time. X-rays were sent to the manufacturer for review, and no discontinuities or anomalies were observed. An ultrasound report was received indicating that there was some fluid around the lead and at the generator site. The neurologist believes the ultrasound report suggests that the patient may have an infection. Both the neurologist and surgeon think the pain may be a neuralgia from the surgery, though this has not been confirmed. Both do not think the event is permanent in nature. The patient was treated with another round of antibiotics. Additional information revealed that the patient was evaluated by a different surgeon. Evaluation by that surgeon showed that the patient's pain in her neck has improved and there is currently no infection. Review of the manufacturing records show that the product was sterilized prior to distribution.

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« Reply #24 on: January 24, 2019, 04:55:54 AM »

Model Number 103
Event Date 05/16/2013
Event Type  Injury   
Event Description
It was reported that the patient¿s generator site was infected. There was puss presents. Antibiotics were prescribed but did not help and the generator was explanted. 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.
 
Event Description
It was reported that the patient had lead explant surgery on (b)(6) 2013. Pus was reportedly oozing from the generator site and antibiotics were unsuccessful in resolving the infection. Therefore, the generator was explanted on (b)(6) 2013.
 
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 surgeon mentioned that the originally implanted leads that were explanted were placed on a sensory nerve and not on the vagus nerve. On (b)(6) 2013, the patient presented with redness at the implant site and the patient subsequently later had generator removed. The patient returned to the neurosurgeon¿s office on (b)(6) 2013 with drainage from the incision site and was admitted to the hospital for washout on (b)(6) 2013. She presented at the other hospital on (b)(6) 2013 for a second opinion and then had the lead explant on (b)(6) 2013.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not provide details about antibiotics not helping to resolve the infection.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3241380
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dennis100
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« Reply #25 on: January 24, 2019, 04:56:59 AM »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that the patient's the device was previously turned off due to painful stimulation. Explant may occur due to reasons unrelated to vns therapy. However, no known surgical interventions have occurred to date.
 
Manufacturer Narrative

 
Manufacturer Narrative

Event Description
Analysis was completed on the explanted products. In the pa lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Analysis in the analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Note that since a 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.
 
Event Description
Additional information was received stating that the vns patient¿s swollen generator site was causing the patient to experience painful stimulation. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
On (b)(6) 2014, it was reported that the generator site is "extremely" swollen (described as the size of a pocket with four generators inside), which has been like this for about a year. It was confirmed that the swelling was not normal. The patient also reports periodic swelling at the incision site in the neck. Normal mode diagnostics were performed with showed dcdc = 3. It was noted that the patient recently had an mri and it was not turned off during the procedure. At this time, the patient would like it resolved since she is getting efficacy and would prefer to not have the device explanted. Surgery is likely, but has not occurred to date.
 
Event Description
It was reported that the patient's vns was explanted on (b)(6) 2015 due to the patient not wanting vns any longer and feeling that vns did not help her. Both the generator and majority of the lead was explanted. On (b)(6) 2015, the patient was doing well after explant. The nurse reported that the patient has a lot of psychiatric issues, so the patient thought vns was causing a lot of the problems. However, the nurse does not think that vns necessarily was and that it was likely more psych-related. The explanted devices have not been received by the manufacturer for analysis to date. Clinic notes dated (b)(6) 2015 reported that the presented to the clinic on (b)(6) 2014 with complaints of left shoulder and chest being "inflamed. " she was advised to go to nearest er for evaluation but the patient declined. At that time, the patient was still wanting the vns settings to be adjusted. The neurologist assessed that since the patient had non-epileptic seizures, there was no plan to revise the vns. However, due to the patient's complaints, the decision was made to explant the vns. The patient reported redness and warmth over the left chest intermittently and typically applied an icepack to the area to relieve the symptoms. The patient stated that she had symptoms related to the vns when it is on, including throat tightness and right shoulder pain. However although the device was off, the patient still complained of difficulty swallowing at times with right arm pain and swelling. Therefore at that time, the surgeon assessed that the events very likely may have not been related to vns.
 
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dennis100
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« Reply #26 on: January 25, 2019, 09:36:41 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/30/2014
Event Type  Injury   
Manufacturer Narrative
Age at time of event, date of birth; corrected data: the previously submitted mdr inadvertently did not provide age for the patient. Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Device available for evaluation?; corrected data: the previously submitted mdr inadvertently did not provide the information.
 
Event Description
It was reported that the patient had recently undergone generator replacement prior to the infection. It was reported that the patient presented with erythematous swelling to the wound and debridement occurred with explant. The generator was cultured and noted to have staphylococcus aureus. The patient is being treated with oral antibiotics. The explanted generator was received for analysis. The returned product form indicated that the generator was not replaced during explant surgery. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification.
 
Event Description
It was reported that vns patient underwent generator replacement on (b)(6) 2015. The lead impedance of the implanted vns system was 1993 ohms. It was reported that the decision made for replacement is due to patient having increase in seizures without the vns therapy.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2014 to explant the patient¿s generator due to infection. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012597
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dennis100
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« Reply #27 on: February 14, 2019, 02:07:06 AM »

Model Number 104
Device Problem Fracture
Event Date 02/11/2015
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 patient had an infection following generator replacement and that the patient would undergo generator replacement the next day due to the infection. During the generator replacement surgery a lead fracture was also identified. The lead fracture is reported in mfr. Report # 1644487-2015-04270. Both the generator and lead were explanted as the physician did not plan to perform both lead and generator replacement. The patient has been admitted to the hospital and is being followed by infectious disease and will undergo device reimplant once cleared by infectious disease. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Product analysis has been completed for the generator and lead. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead was completed on 03/30/2015. No obvious anomalies were noted with the returned lead portion that was not attributed to the explant procedure. Analysis of the lead is reported and captured in mfg report #: 644487-2015-04270.
 
Manufacturer Narrative
Suspect device udi: (b)(4). This information was inadvertently left off of initial mfr. Report.
 
Event Description
Clinic notes dated (b)(6) 2015 reported that the patient's incisions were healing well, and that the vns system was intended to be replaced after approval from the treating physician. The clinic notes indicated that the incision still had seepage. Cultures were taken and showed (b)(6), with the infection thought to be limited to the generator pocket. The patient was treated with iv antibiotics. Clinic notes dated on (b)(6) 2015 reported that the incision had healed, and that re-implantation would be scheduled. The patient was seen by an infectious disease specialist on (b)(6) 2015 where it was noted there was an increase in erythema and pain at the left chest incision where the leads were clipped. The site at the generator was reported to be doing well. It was then reported by the surgeon on a visit on (b)(6) 2015 that the remaining lead would be removed due to the remaining infection. The remaining portion of the lead was removed on (b)(6) 2015. The device was discarded and is not available to be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638165
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dennis100
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« Reply #28 on: February 16, 2019, 02:48:03 AM »

Model Number 103
Event Date 02/10/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital for complaining of a possible infection due to some redness and swelling around the generator site. The patient did not have an infection but the patient was given antibiotics due to the prophylactically due to the fever. It was reported that the redness and swelling was very minimal and may have been caused by sleeping on that part of the chest or patient manipulation. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4600900
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dennis100
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« Reply #29 on: February 18, 2019, 01:24:24 AM »

Model Number 105
Event Date 11/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Information was received from the surgeon on (b)(6) 2015. According to the patient the swelling, redness, and fluid accumulation started around (b)(6) 2014 after routine generator replacement the month before. The events are related to the presence of the device. Interventions were taken both for patient comfort and to preclude a serious injury. Additional interventions included wound irrigation and local steroid injections. The interventions were of minimal help. The surgeon believes the patient has developed a titanium allergy or hypersensitivity and that the only recourse is to totally remove the generator and lead. All cultures for infection have been negative.
 
Event Description
Additional information was received stating that the patient underwent generator replacement on (b)(6) 2015 for the previously reported infection. The explanted product was not returned to the manufacturer to date.
 
Event Description
It was reported that the patient will be undergoing surgery to reposition the vns generator as it is extruding from the skin. There was no patient manipulation that led to the extrusion. The implanting surgeon did not use an absorbable suture for the placement of the generator and there were no known trauma or obvious cause for the extrusion of the device. The patient was seen by the neurologist¿s office in (b)(6) 2014 when patient had initially reported the extrusion but the neurologist office could not identify the cause of device extrusion. The patient underwent repositioning surgery on (b)(6) 2015. Following surgery, the patient experienced swelling, pain and redness in the chest. The patient was prescribed antibiotics prophylactically to prevent an infection. It was later reported that the patient had fluid coming from the generator site in the chest. The patient was admitted to the hospital on 02/20/20115 for the infection and was administered with antibiotics intravenously.
 
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=4565524
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