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dennis100
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« Reply #2880 on: February 26, 2019, 02:22:19 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/08/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient has an infection at the generator site, possibly due to the fact that the patient suffered a knock at the generator site. The patient has been given antibiotics for the infection. Additional information was received that the surgery occurred on (b)(6) 2017 where the generator was removed. A review of device history records showed that the implanted generator was sterilized prior to distribution. All other quality tests also passed prior to distribution. No additional relevant information has been received to date.
 
Event Description
Additional information was received that both the generator and lead were explanted and returned for analysis. The generator underwent product analysis and 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. Communication was ok, lead impedance and current delivered were normal for all diagnostic tests performed. Potential contributing factors to the infection and protrusion have been considered and evaluated, and none were found to exist in this situation. The pulse generator passed all specifications prior to its release. The entire lead was not returned, and therefore an evaluation cannot be made on that portion of the lead. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6844410
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dennis100
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« Reply #2881 on: February 28, 2019, 03:29:52 AM »

Model Number 304-20
Event Date 07/02/2015
Event Type  Injury   
Event Description
It was reported that a newly implanted patient acquired infection in the neck incision site. The patient was treated with iv antibiotics in the hospital for a couple of days and was sent home. Patient was reported to be stable on (b)(6) 2015. The patient's culture was identified to be staph infection.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization of both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4958115
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dennis100
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« Reply #2882 on: March 01, 2019, 02:30:09 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953442
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dennis100
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« Reply #2883 on: March 01, 2019, 02:30:52 AM »

Model Number 303-20
Device Problems Disconnection; Loose or Intermittent Connection
Event Date 09/10/2014
Event Type  Injury   
Event Description
It was reported that the vns patient presented swelling of a surgical scar. The patient had undergone surgery for treatment of an infection and protrusion, as reported in the mfr. Report # 1644487-2015-04683. It was reported that the recovery of the incision was evolving well, but a month later the swelling of the scar debuted. It was reported that the healthcare professional suspected that the implanted lead loops were irritating the patient¿s neck and the scar was loosening due to friction. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution. Further information was received indicating that the patient underwent surgery to assess the reported granuloma, which had worsened in the neck at the original location of the tie-downs. The lead was explanted and pieces of it were used to run an allergy test on the lead¿s material. When the generator pocket was opened for disconnection of the lead pin similar tissue growth formations similar to those found in the neck were found all throughout the generator pocket. The pulse generator was explanted and disabled. The tissue growth formation was removed from the generator pocket and the neck incision area and they were sent for microbiological testing and pathology studies. The remaining portions of the lead and the generator were returned to the manufacturer. Analysis of the devices is underway, but it has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong codes for the event.
 
Event Description
Further information was received indicating that allergy test had been run which ruled out an allergy. It was believed that the patient had and infection. The returned pulse generator was analyzed and no performance or any other adverse condition was found. Analysis of the returned lead found no anomalies in the returned portions. No discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4945967
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dennis100
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« Reply #2884 on: March 03, 2019, 04:51:00 AM »

Model Number 304-20
Event Date 12/03/2013
Event Type  Injury   
Event Description
It was reported that the patient underwent generator and lead reimplant on (b)(6) 2014. Device diagnostics with the new vns system were within normal limits.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the vns patient underwent surgery (b)(6) 2013 to explant her generator and lead due to an infection that developed at her generator and lead sites. The generator and lead sites had redness that progressively worsened following lead replacement surgery on (b)(6) 2013. 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=3782313
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dennis100
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« Reply #2885 on: March 04, 2019, 08:27:37 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/25/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that a patient was experiencing post-surgery issues. The patient has a rash which is believed to be what led to the patient picking a hole at the incision site. The patient was implanted with this device on (b)(6) 2015. Notes dated (b)(6) 2015 state that the patient was picking at the site over the weekend and then on monday exposed one of her wires. The generator was noted to be removed on (b)(6) 2015 to ensure she does not get an infection. The lead was removed as well. The design history records were reviewed for the generator and lead and it was confirmed that the devices were hp sterilized prior to release into the field. The devices were discarded after surgery so will not be returned for analysis.
 
Event Description
The patient underwent a full re-implant on (b)(6) 2015.
 
Manufacturer Narrative

Event Description
It was indicated on 09/13/2016 from the physician's assistant that the patient had an infection at the cervical area and generator site.
 
Manufacturer Narrative
Correction, udi inadvertently omitted from initial mdr for suspect device, (b)(4).
 
Event Description
On (b)(6) 2015 clinic notes were received for patient referral for re-implant. The notes dated (b)(6) 2015 indicate that the physician believes the aspire generator has inferior sterility or has a metal composition different from previous generator models which he believes contribute to the extrusion which resulted in the patient's device being explanted. Notes dated (b)(6) 2015 did state that the device was successful for the two months it was implanted according to the patient's mother and physician. The patient was scheduled for re-implant but this has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5036775
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dennis100
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« Reply #2886 on: March 06, 2019, 01:55:45 AM »

Model Number 304-20
Device Problem Extrusion
Event Date 07/14/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
Patient underwent full revision of lead and generator on (b)(6 2015.
 
Event Description
It was reported that the patient's lead site was eroding through the skin so the physician explanted both the generator and the lead. It was reported that the patient would be reimplanted in 6-8 weeks. No known surgery has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Follow-up was performed with the neurosurgeon's physician assistant. The patient went to the er on (b)(6) 2015 because 2 weeks prior, her mother noticed what appeared to be an infected stitch. They removed the stitch in the er and the lead wires became exposed. They presumed that the "entire system" was infected and decided to remove the entire system. Cultures were positive for (b)(6). Interventions were removal of the vns system and antibiotics for 14 days. Interventions were taken to preclude serious injury. Patient was seen for follow-up on (b)(6) 2015 and was healing well. The events are thought to be related to the surgery. There is a plan to re-implant. A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution. A company representative received information from another physician assistant, who reported that this was a case where the deep stitch was not tight enough. The stitch comes loose and the patient grabs at it. She believed the surgery was the reason for the stitch coming loose.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4973866
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dennis100
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« Reply #2887 on: March 07, 2019, 02:01:48 AM »

Model Number 304-20
Event Date 08/20/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the recently implanted vns patient developed cellulitis of the neck and was given an antibiotics regiment. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5108615
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dennis100
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« Reply #2888 on: March 07, 2019, 02:03:19 AM »

Event Type  Malfunction   
Manufacturer Narrative

Event Description
An article titled "long-term expectations of vagus nerve stimulation: a look at battery replacement and revision surgery" was reviewed. It is noted in the article that the patient's vns generator was removed due to infection. The infection was reported to be associated with the implant surgery. It is unknown if the generator was placed subpectorally or subcutaneously for this patient. One of the most heavily colonized areas of the skin by pathogenic microorganisms is the axillary area, and the generator was placed with a para-axillary approach. Whenever possible, the surgeon removed the entire infected vns implant, including the coil wrapped around the vagus nerve. However, it is unknown if the lead was removed for this patient. The surgeon routinely uses the following methods: use of multiple chlorhexidine surgical scrubs and preps, double gloving with outer glove changes after draping and before handling hardware, and administering 48 hours of prophylactic oral antibiotics. Attempts for additional relevant information including patient details were unsuccessful. This article also reports other events as previously mentioned in manufacturer report # 1644487-2015-05918.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5109477
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dennis100
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« Reply #2889 on: March 08, 2019, 01:34:59 AM »

Event Date 10/13/2018
Event Type  Injury   
Event Description
Article titled "vagal nerve stimulation for epilepsy in adults: a database risk analysis and review of the literature" was reviewed and two adverse events were identified for the patients studied within the cohort. 1 patient had a superficial site infection. 1 patient returned to the operating room for an unspecified reason. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8302605
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dennis100
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« Reply #2890 on: March 08, 2019, 01:35:35 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2018
Event Type  Injury   
Event Description
Article published to assess indications of vns revisions and explants. The article included the following reports related to vns: 1 patient experienced hematoma requiring medical management. 4 patient's experienced infection resulting in antibiotic treatment to suppress the infection (with no resolution) and lead removal. Other adverse events reported in file captured in mfr. Report # 1644487-2019-00216 and mfr. Report #1644487-2019-00217 no other 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=8302926
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dennis100
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« Reply #2891 on: March 08, 2019, 01:36:17 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 #2892 on: March 08, 2019, 01:36:54 AM »

Model Number 300-20
Device Problem Fracture
Event Date 01/16/2019
Event Type  Malfunction   
Event Description
The physician reported that the patient had experienced a lead fracture and their generator had migrated to the right side of their chest. It was stated that the patient¿s lead and generator were explanted. It was later discovered during follow up with the sales representative present at surgery that the patient also had an infection. Generator migration and infection events have been reported in mfg report # 1644487-2019-00243. Further follow up with surgeon confirmed that lead fracture was determined via x-ray, and that the believed cause of the lead fracture was due to generator migration. The surgeon mentioned that they do not know reason for generator migration due to patient being lost to follow up. However, it was noted that the generator was previously secured with absorbable sutures (o-vicryl). The surgeon also mentioned that the infection occurred at generator site due to skin breakdown. No other relevant information is known at this point in time. It was stated that the lead was discarded after surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8324971
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« Reply #2893 on: March 08, 2019, 01:37:34 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2018
Event Type  Injury   
Event Description
The nurse reported that a patient had both vns generator and lead explanted due to a badly infected wound site. The nurse stated that the infection was present at both generator site and lead site. The patient has had several infections including a previous vns explant due to infection, captured in mfr report # 1644487-2018-00994, and an infection that lead to an above the knee amputation. Therefore, the patient was seen by an immunologist to ensure there were no underlying factors causing these infections and none were evident. Device history records were reviewed and showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No other relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8338649
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dennis100
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« Reply #2894 on: March 09, 2019, 02:51:15 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/05/2013
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported in clinic notes received for the patient¿s replacement that the patient had signs and symptoms of infection noted. The clinic notes also stated that the incisions were healing well. No interventions were noted. Device history records were reviewed and the generator and lead were sterilized prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No additional information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8331925
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« Reply #2895 on: March 09, 2019, 02:51:47 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient was explanted in (b)(6) 2016 due to an infection. Follow up with the physician indicated that the patient has their device explanted while living in another state. While the patient was with them, they were escalating the vns and didn't note any infection. The physician did not have any other information. The device history records of the generator and lead were reviewed, and the devices were sterilized according to procedure prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8320019
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dennis100
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« Reply #2896 on: March 09, 2019, 02:52:27 AM »

Model Number 303-20
Device Problem Corroded
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
It was reported that the patient underwent vns explantation surgery due to an infection. This was reported in mfg. Report #1644487-2018-01619. The explanted products were received by the manufacturer. Device evaluation was determined as not necessary for mfg. Report #1644487-2018-01619 because the reported event were determined as not related to vns therapy and, therefore, no supplemental report was performed for that file. Lead product analysis was completed. Scanning electron microscopy images suggesting pitting or electro-etching conditions occurred on the connect ring surface. Generator product analysis indicated that the generator was received programmed on. No obvious adverse effect on device performance was identified as a result. The product was received with the lead connector portion of the lead still attached to the generator header. A continuity check between the set-screw and end of the lead portion passed. Other than the above mentioned and typical wear/explant related observations, no other anomalies were identified in the returned lead portions. Generator product analysis was completed. The dhr indicates that the generator passed all specifications prior to release. The diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance or other adverse conditions found within the pulse generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8335812
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dennis100
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« Reply #2897 on: March 09, 2019, 02:53:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported by the patient¿s mother that the patient had an infection following their device implant surgery. The infection was cleaned out. The patient picked at their device a few months later and was given antibiotics. The site is now healed without redness or heat. The device history records were reviewed for the generator and lead, and the devices were sterilized prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8335674
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« Reply #2898 on: March 09, 2019, 02:53:51 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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« Reply #2899 on: March 09, 2019, 02:54:26 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Injury   
Event Description
It was reported that a patient had an infection at the neck site that was about the size of a golf ball. It was stated that the patient had picked at the site and has had an infection for about two weeks. The physician prescribed antibiotics. No additional, relevant information was received to date.
 
Manufacturer Narrative
Device evaluated by mfr?, code 81: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8338214
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« Reply #2900 on: March 09, 2019, 02:55:02 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8311627
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« Reply #2901 on: March 09, 2019, 02:55:38 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/13/2010
Event Type  Injury   
Event Description
Incoming communication indicated that the patient was referred for re-implant of the vns. Because the re-implant of the patient is not relevant to the reported serious injury of infection, no further updates related to the re-implant will be reported. This report is a continuation of medwatch mfr. Report #1644487-2011-00793.
 
Manufacturer Narrative
This report is a continuation of medwatch mfr. Report #1644487-2011-00793. Device evaluated by mfr? device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8341818
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« Reply #2902 on: March 09, 2019, 02:56:08 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/24/2019
Event Type  Injury   
Event Description
Patient underwent explant of the generator and lead due to infection. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted products were received by product analysis. Device evaluation is not necessary as reported infection is not related to the functionality or delivery of therapy of the device. No other 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=8373409
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« Reply #2903 on: March 10, 2019, 02:24:22 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/05/2018
Event Type  Injury   
Event Description
It was reported that a patient had a bump to the left of her incision site, which was treated with antibiotic spray. The bump recently burst, however had not completely gone away. It was also noted that the patient feels her incision site healing. Follow up with the physician's office confirmed that there was an infection at the site. It was stated that the bump was at neither the generator nor lead sites, and did not have drainage. The physician had no assessment for the bump/infection. Both the implanted generator and lead were confirmed to have been sterilized prior to the distribution. Both devices passed all quality inspections prior to distribution. No additional relevant information was received to date.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8298382
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« Reply #2904 on: March 11, 2019, 08:00:25 AM »

Model Number 304-20
Device Problems Fastener; Device Slipped
Event Date 08/26/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that the patient's incision site is still showing signs of infection. It is unknown what treatment plan the patient will undergo at this time.
 
Event Description
It was reported that the patient was scheduled for explant due to the infection. The vns was removed on (b)(6) 2015.
 
Event Description
On (b)(6) 2016 it was reported that the patient's lead would be explanted as well. Although surgery is likely, it has not occurred to date.
 
Event Description
The physician later reported that she is not aware of any patient manipulation or trauma that is believed to have caused or contributed to the tie-down becoming loose.
 
Event Description
The physician reported that only the generator was explanted on (b)(6) 2015.
 
Event Description
It was reported that the patient has an infected lead. The manufacturing record for the lead was reviewed and sterilization was confirmed prior to shipment. The patient underwent surgery on (b)(6) 2015 and it was found that a loose tie-down was causing the perpetual wound infection. The physician noted that this was the second time it was loose. The vns remains implanted and there was no infection down inside the wire. The tie-down was loose causing a granuloma. Additional information has been requested but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5090558
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dennis100
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« Reply #2905 on: March 13, 2019, 01:40:36 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5059042
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dennis100
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« Reply #2906 on: March 14, 2019, 06:24:35 AM »

Device Problem Insufficient Information
Event Type  Injury   
Event Description
An article titled "vagus nerve stimulation in children with drug-resistant epilepsy: age at implantation and shorter duration of epilepsy as predictors of better efficacy?" was published and the abstract was reviewed, which included adverse events involving 4 vns patients. One child had a wound infection three weeks after implantation requiring intravenous antibiotics and eventually replacement of the vns device. In 3 other patients, a lead break necessitated re-intervention. This manufacturer report involves the patient who presented infection three weeks after implant. The manufacturer report # 1644487-2015-06251 involves the first patient who underwent surgery due to lead break. The manufacturer report # 1644487-2015-06252 involves the second patient who underwent surgery due to lead break. The manufacturer report # 1644487-2015-06253 involves the third patient who underwent surgery due to lead break.
 
Manufacturer Narrative
The previously submitted medwatch report was found to be a duplicate of the medwatch report # 1644487-2010-02147.

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dennis100
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« Reply #2907 on: March 16, 2019, 01:57:21 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 12/10/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
A provider reported that a patient experienced left-sided vocal cord paralysis attributed to vns implantation surgery. It was reported that the patient's vns system was subsequently removed to allow the vocal cord paralysis to heal. The patient has not been re-implanted to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was clarified that the patient was diagnosed with vocal cord paresis following explant of the patient's vns system. The explant of the patient's vns system was due to infection (reported in mfr. Rpt# 1644487-2015-06367). The vocal cord paresis was deemed to be related to the device explant procedure. The patient will be reassessed at a future date for possible vns re-implantation. No known interventions have been reported for the vocal cord paresis.

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dennis100
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« Reply #2908 on: March 16, 2019, 01:58:13 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.

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dennis100
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« Reply #2909 on: March 18, 2019, 02:17:52 AM »

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

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