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dennis100
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« Reply #30 on: February 19, 2019, 03:37:31 AM »

Model Number 103
Event Date 01/27/2015
Event Type  Injury   
Event Description
It was reported that the vns patient developed an infection at the generator site following generator replacement surgery on (b)(6) 2015 due to low battery. The generator site was found to be swollen, red, and oozy during an office visit on (b)(6) 2015. The patient was subsequently given antibiotics and the infection later resolved. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Clinic notes were subsequently received indicating that the patient experienced a post-operative infection (left chest)/incisional abscess at the site of the vagal nerve stimulator pocket on (b)(6) 2015. It was described that unspecified conservative therapy had been attempted but was unsuccessful. The patient underwent incision, drainage and debridement of the left chest wall incision on (b)(6) 2015. It was stated that a wound vac was placed and the patient was treated long-term with antibiotics. The wound vac was discontinued at a later date and antibiotic treatment was continued.
 
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=4719619
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dennis100
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« Reply #31 on: February 19, 2019, 03:38:17 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
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dennis100
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« Reply #32 on: February 22, 2019, 08:09:03 AM »

Model Number 302-20
Event Date 02/10/2011
Event Type  Injury   
Event Description
It was reported by a surgeon that a vns patient had extrusion of a lead connector which was removed in february (mfr. Report # 1644487-2011-00435) and a sensitive staph grew on broth culture. She then had an admission for vns site infection in june with high wcc but no organism isolated. Patient also presented with redness and swelling around the vns and had been treated with fluciox and cephalexin.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2308197
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dennis100
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« Reply #33 on: February 25, 2019, 02:29:43 AM »

Model Number 103
Event Date 04/07/2015
Event Type  Injury   
Event Description
It was reported that recently implanted vns patient developed what appeared to be an infection at the generator site. The patient presented with redness and swelling which resolved with antibiotics. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
(b)(4). 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=4763430
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dennis100
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« Reply #34 on: February 26, 2019, 02:12:45 AM »

Model Number 105
Event Date 05/22/2015
Event Type  Injury   
Event Description
It was reported that the patient was undergoing a left chest wall repair surgery on (b)(6) 2015, but did not know the reason for the surgery. It was later reported that the patient went to er a few weeks ago for redness and swelling around the generator incision site and was given antibiotics for possible infection. On (b)(6) 2015, the surgeon irrigated the incision site with the patient under anesthesia. The surgeon noticed some redness at the generator incision site, but no puss was found. The incision was healing well, so the surgeon did not go very deep into the wound. The patient was put on more antibiotics as the regimen from the er was finished.
 
Manufacturer Narrative
(b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4885885
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dennis100
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« Reply #35 on: February 26, 2019, 02:13:37 AM »

Model Number 304-20
Event Date 04/07/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 from the patient who reported a painful red lump having appeared on his neck within the last few months. The patient was implanted in (b)(6) 2014. The patient stated that the area looks kind of infected and has a large knot on it. He reported pain at the site and redness on the mass. It was recommended he contact his physician or surgeon regarding the issue. Follow-up with his physician showed that the patient did not show for two of his scheduled appointments. Therefore, no additional information has been obtained.
 
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=4743698
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dennis100
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« Reply #36 on: March 03, 2019, 04:47:20 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/07/2016
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 that the patient had been hospitalized due to infection, attributed to the vns surgery, and a low white blood cell count. The patient was implanted over a year prior. The patient's generator was turned off and serosanguinous fluid was removed with a needle. The fluid did not appear to be infectious and the patient was placed on antibiotics for 24 hours to see if white blood cell count improved. Clinic notes reported that an ultrasound showed a small amount of fluid increase in the pocket with no definite drainable fluid collection. It indicated stable edema with a slight increase in redness. The skin was tender and the scar inflamed. There was evidence of cellulitis of the skin of the surrounding area. The patient was on iv antibiotics. The notes indicated that the infection was present but that the patient's arm movement was improving. The patient's lead and generator were explanted. The manufacturer's device history records were reviewed. Sterilization of the suspect device prior to distribution was confirmed. The company representative then said that the surgeon hadn't believed it was related to the vns because the patient had had no signs of infection since the initial implant. No further relevant information has been received to date.
 
Event Description
The company representative later clarified that when the surgeon had indicated that he hadn't believed the infection was related to the vns, he meant that the infection wasn't related to the vns device itself not necessarily vns surgery. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6841022
« Last Edit: June 10, 2019, 12:41:12 AM by dennis100 » Logged
dennis100
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« Reply #37 on: March 04, 2019, 08:20:56 AM »

Model Number 103
Device Problem Migration or Expulsion of Device
Event Date 05/08/2015
Event Type  Injury   
Event Description
It was reported that the vns patient woke up on (b)(6) 2015 with pain in the neck and redness around the generator site. Infection was suspected so the patient was given antibiotics. The patient's generator site was observed to be swollen and tender to touch, but the patient did not have a fever. Follow-up revealed that the surgeon did not suspect an infection but stated due to the patient's flexed posture, arm position and spasticity, the patient developed a hematoma that liquefied and caused the generator to pull away from the original implant site. Patient was given antibiotics as a precaution. Additional information was received stating that patient had developed an infection and was referred for surgery. The surgeon attributed the infection the generator migration and planned to re-implant the device deeper underneath the pectoral muscle. An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2015.
 
Event Description
The explanted vns generator was received by the manufacturer for analysis. However, analysis has not been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4907118
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dennis100
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« Reply #38 on: March 08, 2019, 01:31:53 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for vns explantation surgery. Follow up with the surgeon's office revealed that the main reason for explantation was that the patient's parents did not feel that the vns was helping with the patient's seizures. It was also noted that there was a wound on the incision site that had never healed properly. It was reported that it was treated with antibiotics, but redness and swelling were still present. It was stated that the neurologist was in agreement with the patient's parents that the vns did not improve the patient's seizures. Follow up with the company representative revealed that the surgeon stated that there was a local infection at the implant site. The surgeon informed the patient's parents that the infection could be treated with antibiotics, but they elected to explant due to the lack of efficacy. It was stated that there had been no decrease in seizures since the implantation surgery. Diagnostics were within normal limits and the patient was programmed to manufacturer-defined therapeutic levels. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. The patient underwent full vns explantation surgery. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is 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=8378792
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dennis100
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« Reply #39 on: March 09, 2019, 02:36:12 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/16/2018
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 the patient presented to the surgeon's office not long after implant as his neck incision site was red and infection. A couple days later, the lead had completely exposed out of the skin. The surgeon believed that the patient had picked at the site. As a result, the patient's generator and lead, including the anchor tether, were later removed. The other two electrodes were later removed as well as the patient's infection did not clear and progressed to mrsa (staph infection). Device history records were reviewed for the implanted lead and it was confirmed that the device was sterilized prior to distribution. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8338201
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dennis100
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« Reply #40 on: March 14, 2019, 06:17:54 AM »

Model Number 103
Device Problem Material Protrusion / Extrusion
Event Date 05/01/2015
Event Type  Injury   
Event Description
It was reported that patient had his vns device removed. It was reported that the vns system was implanted in (b)(6) 2015, but patient suffered a wound infection on the generator site in (b)(6) 2015. It was reported that patient was admitted for this infection and treated with iv anti -biotics, patient subsequently recovered and was discharged home. It was reported that patient was seen in (b)(6) 2015 for follow up and on inspection of the wound it was found to be extremely swollen, red and the device appeared to be protruding through the skin. Patient was admitted for investigation and the device was explanted on (b)(6) 2015.
 
Manufacturer Narrative
Date of implant; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Event Description
Review of manufacturing records confirmed that both, the generator and the lead were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5188050
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dennis100
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« Reply #41 on: March 16, 2019, 01:47:29 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
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dennis100
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« Reply #42 on: March 16, 2019, 01:48:14 AM »

Model Number 106
Event Date 08/25/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on that this patient was recently implanted on (b)(6) 2015 and the device was activated on (b)(6) 2015. The patient's mother called in stating that the patient is complaining of shocking sensations at the site of the generator. When the patient's device was activated, the patient tolerated that well. It was then noted from a nurse at the surgeon's office that she as a 4 inch line from the generator up to her neck that is red, swollen and hot. The patient states it keeps shocking her. There was no breakdown of the incision and the incision was said to look nice. It was noted that the patient was being admitted. The patient had a 3rd dosing and she tolerated well. The patient was diagnosed with cellulitis and it is now resolved with medication and iv. The infection was attributed to the implant procedure. The patient is now doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5131124
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dennis100
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« Reply #43 on: March 21, 2019, 01:14:21 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient is infected. It is believed to be a blood infection. The patient's vns was explanted on (b)(6) 2015. The patient's device had recently been implanted on (b)(6) 2015. The manufacturing records for the lead and generator were reviewed and both devices were sterilized prior to shipment.
 
Manufacturer Narrative
Evaluation codes (refer to coding manual), conclusions; corrected data: inadvertently listed incorrect conclusion code on initial report.
 
Event Description
On (b)(6) 2016 the physician reported that a blood culture was taken on (b)(6) 2015 which showed positive for sphingomonos pacimobils and the patient had some redness at the generator location. Therefore the patient was admitted and started on vanco. On (b)(6) 2015 the wound appearance started to separate and a blood culture was then taken on (b)(6) 2015 which showed positive for staph aureus. The device was therefore explanted on (b)(6) 2015. The physician indicated that the patient has severe retardation and he suspects the patient may have palpated the incision to cause the staph infection. The physician also mentioned that he was not aware that the patient had a severe urinary tract infection prior to the patient's generator replacement on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5194576
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dennis100
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« Reply #44 on: March 24, 2019, 02:56:04 AM »

Model Number 106
Device Problem Insufficient Information
Event Date 11/02/2015
Event Type  Injury   
Event Description
It was reported that a patient, recently implanted with vns system, had pain and hoarseness. The patient was stating that it was tight and hurting a lot. It was reported that the patient was seen by a nurse and her physician, where she received antibiotics because the incision looked red. But the patient's throat was sore and her voice was still hoarse. It was reported by the nurse that the device had not been turned on yet, so the pain and soreness was likely a result of the surgery. Further information received indicates that the patient was again seen in clinic and she was doing well; the pain has stopped and her wound was dry. The patient's voice has been settled. It was reported that the device is now turned on. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Additional manufacturer narrative and/or corrected data, corrected data: (b)(4). The suspect device udi was inadvertently not provided in the initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5260052
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dennis100
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« Reply #45 on: March 24, 2019, 02:56:57 AM »

Model Number 304-20
Event Date 08/25/2011
Event Type  Injury   
Event Description
Analysis of the explanted vns lead and generator has been completed. The electrode portion of the lead was not returned. No anomalies were observed in the returned portion. Analysis of the generator found no anomalies and it performed to specifcations.
 
Event Description
Additional information was received indicating the remainder of the vns lead has been explanted. The rest of the lead was returned and underwent analysis. No anomalies were observed in the newly returned portion of the lead.
 
Event Description
Additional information was received stating that the vns patient will not be re-implanted. The surgeon suggested that the patient should wait a few years before being re-implanted to allow the patient to grow. The patient was prescribed new medication by her neurologist and reported to be doing fine.
 
Event Description
It was reported by the surgeon that the patient had to go back to the operating room to re-secure the lead and remove a tie-down that was protruding beneath the skin. Follow-up with the surgeon's office found that the patient had inflammation in her left neck and swelling. The tie-down was protruding through the skin; however, no skin rupture had occurred. It was noted that the patient skin is naturally thin at electrode site likely leading to the protrusion and irritation. At a recent follow-up visit, the patient's mother stated that the wound site appeared to be getting worse after it had been healing well. The surgeon noted that there was only redness and no other signs of infection; however, the patient was given a refill of antibiotics as a precaution. No infection is believed to be present at this time; however, the surgeon's office will contact the manufacturer if an infection is believed to be present. No trauma or manipulation has been reported.
 
Event Description
Additional information was received from the physician indicating that the extrusion and possible infection were a result of the patient picking at her wounds. The patient had two surgeries to relocate the lead further underneath the patient's skin however the extrusion issues persisted. The surgeon eventually decided to explant the patient's vns lead and generator. Cultures were taken to rule out a possible infection however the results have not been provided at this time. The explanted products have been returned and are currently undergoing analysis. The return product form received with the explants indicated that the "lead was starting to come out of skin. ".
 
Event Description
Additional information was received indicating that the patient will likely be reimplanted. Surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2260227
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dennis100
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« Reply #46 on: March 24, 2019, 02:58:12 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
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dennis100
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« Reply #47 on: March 25, 2019, 01:29:21 AM »

Model Number 106
Device Problem Insufficient Information
Event Date 12/11/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed a post-surgical infection. The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics. The symptoms of infection had reportedly resolved at that time. Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm. The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis. No interventions for the thrombophlebitis have occurred. The patient was not admitted to the hospital. The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm. A review of device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
Follow up communication indicated that the patient's generator was actually implanted in her left armpit. Additionally, it was indicated that the patient was a regular smoker. This was the same location that her previous generator was located. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5397383
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dennis100
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« Reply #48 on: March 26, 2019, 02:18:59 AM »

Model Number 106
Event Date 12/02/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient may have developed an infection from vns surgery, because there was redness over the generator site. The patient also had an abscess along the suture at the generator incision site. The physician prescribed antibiotics for the infection. No cultures were taken, and no further intervention was planned at that time. The device history record for the generator was reviewed, and the generator was sterilized prior to release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5357938
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« Reply #49 on: March 27, 2019, 01:34:12 AM »

Model Number 105
Event Date 12/01/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
A physician informed an international distributor that a patient had experienced redness in the generator area, thought to be an allergic reaction, which resolved. Redness later appeared in the neck/lead area. The patient was to admitted to the hospital for allergy examination and treatment. Follow up revealed that the redness around the generator started in (b)(6) 2015 and the subsequent redness around the neck/lead area started at the beginning of (b)(6) 2016. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Requests to obtain further relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5462855
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« Reply #50 on: March 28, 2019, 07:25:10 AM »

Model Number 106
Event Date 01/27/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed staph infection at the generator site that required system explant. The physician indicated that during explant she found signs of infection at the generator site and along the lead. It was reported that the tissue was "like concrete" and required her to cut the lead into pieces to remove it. The surgeon indicated that all of the infection was removed and indicated that prior to, during and after surgery they used several precautions to avoid infection. The surgeon indicated that initially after implant the patient was healing fine; however, over time the redness started and the infection became much worse. No patient manipulation or trauma is suspected to have caused the infection. The surgeon indicated that the patient was very cautious about the incision. The surgeon plans to reimplant the patient when the infection resolves. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 03/11/2016. There were no performance or any other type of adverse condition found with the pulse generator. Analysis of the lead was completed on 03/21/2016. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
Clinic notes dated (b)(6) 2016 note that the patient's incisions are all healed. It was noted that the patient would like to proceed with re-implant. The generator will be placed on the right chest given the adhesions on the left chest wall. There is no pain over the patient's scars.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5451173
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« Reply #51 on: March 29, 2019, 08:12:28 AM »

Model Number 106
Event Date 12/16/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing a sharp pain in the chest that was not related to stimulation. The patient had a recent generator replacement surgery, and the surgeon believed that the patient had an infection on (b)(6) 2016. The surgeon disabled the normal mode stimulation, but the pain continued. The surgeon then disabled the magnet mode and autostimulation mode on (b)(6) 2016. The patient's mother reported a red spot or rash on the patient's chest. She stated that the last time the patient's settings were changed was in the middle of (b)(6) 2016. The patient was also prescribed an antibiotic regimen by the surgeon that was to be completed on (b)(6) 2016. The patient reported feeling burning in his left chest on (b)(6) 2016 and that the area was red and warm to the touch. Chest x-rays were performed, and the surgeon stated that the generator had "shifted a little. " clarification was requested, and the notes stated that there was a foreign object next the generator. However, it was discovered that the patient's mother placed the magnet over the generator for the x-ray, which was the "foreign object" that the surgeon saw. The patient's neurologist did not believe that the redness in the chest was related to vns in any way, and he advised against turning off the patient's output currents because the patient had good seizure control with vns. The device history records of the generator and lead were reviewed, and the devices were both sterilized prior to release. Due to the conflicting information, it is not known at this time if the patient has an infection or not. No additional relevant information has been received to date.
 
Event Description
It was clarified that the surgeon prescribed the antibiotics prophylactically. There was no evidence other than the redness and pain at the generator site to indicate that the patient had an infection. Also, the surgeon continued to believe that there was an infection because of the "foreign object" in the x-ray that turned out to be the magnet. The neurologist did not think the redness or pain was due to an infection, but most likely due to the patient picking at the site or from something that happened at school. It was also clarified that the generator had not shifted at all. No further intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529212&pc=LYJ
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dennis100
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« Reply #52 on: April 02, 2019, 01:18:14 AM »

Model Number 304-20
Event Date 05/19/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, the vns patient reported that she has been experiencing some post-operation surgery effects. The patient was implanted on (b)(6) 2012. The patient stated that the vns is protruding, the patient's voice is altered and is high, and the patient's head is turned away from incision mark 4 and there is redness around the site. The patient's mother stated that the patient had to go back to the hospital overnight on (b)(6) 2012 due to pain as the patient had a hematoma and could not turn his head to the left. The patient's voice was still impaired. The patient's mother stated that the patient is doing better now. The physician later stated that they have no explanation for why the patient couldn't turn his head to the left however; the physician did not believe it was due to vns. The pain is located on the right side. No interventions were planned or taken and on (b)(6) 2012 the device was turned on. The physician does not believe the pain is related to vns. The physician clarified that there is no protrusion; the patient's mother was worried because the events occurred right after surgery, but the physician stated that the patient is healing quite nicely. The patient's implanted product information has been requested from the implanting hospital but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2620968
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dennis100
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« Reply #53 on: April 04, 2019, 01:27:13 AM »

Model Number 106
Event Date 05/26/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing redness and swelling near her chest incision after she had initial implant surgery on (b)(6) 2016. A culture was taken and the results concluded that there was an infection near the incision site. The patient was prescribed iv antibiotics. It was later reported that the antibiotics were helping clear the infection. The device history record for the implanted generator and lead were both reviewed and verified that both devices were sterilized per manufacturer specifications prior to release for distribution. No known surgical intervention has occurred to date. Additional relevant information has not been received to-date.
 
Event Description
It was reported that the patient is expected to recover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5746518
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dennis100
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« Reply #54 on: April 04, 2019, 01:27:58 AM »

Model Number 105
Event Date 05/12/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient had complaints of redness, swelling, and pain at the vns generator site. The physician programmed the vns off and referred the patient back to the ent for evaluation of the site for infection. Additionally information was received which stated the patient also believes the generator is heating and not working. The patient stated he has had an increase in seizures as well as a change in seizure type. Later it was reported the physician does not feel the patient's symptoms were related to vns, but believed it was a "nerve issue". It is unknown what the nerve issue is, or what may have caused the nerve issue to occur. A x-ray assessment was provided by the physician which stated "gross satisfactory vagal nerve stimulator. No acute finding". Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes were received due to re-implant surgery referral due to a "problem with the vagus nerve stimulator". It was mentioned in the notes that the patient was still having seizures. The patient's replacement occurred on (b)(6) 2016 and it was noted he was switched from a model 105 generator back to a model 102 generator. After the generator was replaced with the new generator, the system diagnostic results confirmed the device was working as intended. It was reported by the physician's office that the patient was last seen on (b)(6) 2016 and had mild pain, redness, and 4 seizures. It was confirmed that these seizures have increased from her baseline. It was noted that an additional event had occurred which lasted for hours and the patient felt heating around the vns device. There was not reason specifically given for the increase in seizures. It was noted that the vns settings on (b)(6) 2016 were at therapeutic levels and the diagnostics were within normal limits. It was noted the device would not be returned per hospital regulations. It was further reported by the company representative who was at the surgery that the m105 was "faulty" and needed to be replaced, or per patient request, would be removed completely. The patient requested to have a 102 as he did not have any issues with the m102. Per the patient and the surgeon, the believed cause of the burning sensation and irritability was due to the 105 generator. According to the patient, the burning sensation occurred immediately after the 105 settings were adjusted, but continued even after the device was programmed off. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5726096
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dennis100
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« Reply #55 on: April 05, 2019, 01:30:17 AM »

Model Number 106
Event Date 05/10/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient who is subject to a (b)(6)study had the vns neck site red with a visible area of puss present. The severity of the event was moderate. It was reported that the event was unlikely related to study therapy, not related to implant nor to vns stimulation. It was reported that the treatment was not changed but the medication was added. It was reported that the patient is recovering. The event was not indicated as a serious adverse event. Additional information indicated that this adverse event could be related to a "septic arthritis", which occurred after a motorcycle accident the patient had on (b)(6) 2016. Review of manufacturing records confirmed sterilization for the lead prior to distribution. The vns patient's device was tested on 06/05/2016 and system diagnostics returned impedance results within normal limits with 3821 ohms.
 
Event Description
Update received states the drainage and redness as previously report appears to have resolved. Medications were noted to have been provided. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5722869
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dennis100
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« Reply #56 on: April 09, 2019, 12:40:34 AM »

Model Number 106
Event Date 06/13/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
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.
 
Event Description
It was reported that the patient started having redness and swelling at the left neck. The physician performed an ultrasound, which identified a cyst surrounding the remaining portion of the lead. The physician aspirated fluid from the cyst, which was dirty; and looked infected. The patient then had the remainder of the lead explanted. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5835493
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dennis100
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« Reply #57 on: April 10, 2019, 01:32:05 AM »

Model Number 106
Event Date 06/09/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported that vns patient has a surface infection on the generator site and is being referred to neurosurgeon after a short course of antibiotics. Additional information was received that the infection was noticed at 2 weeks follow up following vns system implant. It was reported that mainly generator site was infected but neck was red; patient was pulling and scratching at it. Patient was given course oral antibiotics. It was reported that patient was reviewed by neurosurgeons and no active infection confirmed. Medial aspect of the wound has opened up slightly and will take a little bit of time to heal fully. Patient has been advised to continue with regular dressing changes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5815095
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dennis100
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« Reply #58 on: April 14, 2019, 01:40:22 AM »

Model Number 105
Event Date 11/15/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported by the patient that she had a generator pocket revision on (b)(6) 2014 for the sake of comfort. It was later explained by the physician's office that the patient initially thought she had an infection as she had a fever and the generator site was red; however, the physician ruled out infection. The patient noted she had a stinging pain which was worse with movement. It was confirmed the surgery was performed due to pain, and not to preclude a serious injury.
 
Manufacturer Narrative
This information was inadvertently incorrectly reported on the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5876872
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dennis100
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« Reply #59 on: April 19, 2019, 01:21:26 AM »

Model Number 105
Event Date 09/15/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received that indicates that the patient's generator had began extruding from his body. The site had become red and liquid was seen around the wound area. The device was then explanted on (b)(6) 2016. The surgeon indicated that the extrusion was due to poor wound healing. No other relevant information has been received to date.
 
Event Description
The patient's explanted generator was received on 11/01/2016 and is undergoing product analysis, which has not be completed to date. No other relevant information has been received to date.
 
Event Description
Product analysis was completed on 12/05/2016 for the explanted generator. The generator was able to complete all functional tests with no anomalies identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6069744
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