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dennis100
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« Reply #120 on: May 10, 2018, 12:49:07 AM »

Model Number 102
Event Date 09/02/2013
Event Type  Injury   
Event Description
It was reported that the patient underwent explant due to an infection at the chest generator site. It was reported that the patient was seen outpatient to have the device programmed on and that is when the infection was found. It was reported that the hospital decided to explant on the same date. It was reported that the hospital would not release the explanted devices to manufacturer. It was reported that the physician has not intent on implanting another vns system. It was reported that the infection was not related to vns. There was not patient manipulation or trauma. No culture were taken. It was reported that the wound was open because of the improper implant placement of the generator, which caused the infection.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3487391
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dennis100
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« Reply #121 on: May 13, 2018, 12:41:36 AM »

Model Number 102
Event Date 06/27/2013
Event Type  Injury   
Manufacturer Narrative

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 Action taken: treatment withdrawn.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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3521478
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dennis100
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« Reply #122 on: May 16, 2018, 01:57:27 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3549167
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dennis100
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« Reply #123 on: May 22, 2018, 02:24:24 AM »

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

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

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

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dennis100
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« Reply #124 on: June 05, 2018, 02:45:39 AM »

Model Number 102
Event Date 10/01/2007
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the vns patient underwent a surgery for explantation of the device due to an infection. It was reported that the generator and the lead were both explanted. Follow up with the physician revealed that the patient's implant surgery was in (b) (6) 2007, the patient had developed an infection. Cultures were taken prior to the explantation surgery and the results revealed a "+" infection confirming the event. The explant surgery took place in (b) (6) 2007. In addition, physician's office notes revealed that the patient had also developed an allergic reaction, and dehiscence wound following the implant surgery. Further follow up with the physician revealed that all the events occurred due to the patient picking at his wound. The explanted products were returned to the manufacturer and product analyses have been completed. No anomalies were identified with the products that could have contributed to the reported event. The patient was recently implanted with a brand new device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1590826
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dennis100
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« Reply #125 on: June 08, 2018, 03:00:10 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544810
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dennis100
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« Reply #126 on: June 16, 2018, 01:32:37 AM »

Model Number 103
Event Date 03/19/2014
Event Type  Injury   
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012570
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dennis100
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« Reply #127 on: July 03, 2018, 12:17:29 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1801202
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dennis100
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« Reply #128 on: July 06, 2018, 08:52:19 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/24/2018
Event Type  Injury   
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7596391
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dennis100
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« Reply #129 on: July 06, 2018, 08:52:51 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7592560
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dennis100
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« Reply #130 on: July 07, 2018, 04:13:29 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650669
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« Reply #131 on: July 08, 2018, 01:50:40 AM »

Device Problem No Known Device Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7566864
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dennis100
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« Reply #132 on: July 10, 2018, 07:17:04 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1833656
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dennis100
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« Reply #133 on: July 18, 2018, 03:05:11 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529930
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dennis100
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« Reply #134 on: July 19, 2018, 06:01:44 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532501
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« Reply #135 on: August 07, 2018, 01:05:19 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956374
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« Reply #136 on: August 10, 2018, 03:50:12 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/04/2018
Event Type  Injury   
Event Description
It was reported that surgery was being taken to reposition the patient's generator as the generator had migrated to an axillary position. It was also reported that the generator had been replaced recently and since there had been issues with wound healing and the wound had opened. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726467
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« Reply #137 on: August 10, 2018, 03:50:41 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7723003
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« Reply #138 on: August 11, 2018, 01:02:34 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7664030
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« Reply #139 on: August 14, 2018, 12:42:27 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7293377
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dennis100
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« Reply #140 on: August 25, 2018, 06:00:48 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133615
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dennis100
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« Reply #141 on: September 07, 2018, 11:01:40 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7790584
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dennis100
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« Reply #142 on: September 07, 2018, 11:02:26 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7750790
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« Reply #143 on: September 12, 2018, 02:31:54 AM »

Model Number 103
Device Problem Patient-Device Incompatibility
Event Date 08/24/2011
Event Type  Injury   
Event Description
Additional information was received from a nurse with the surgeon's office indicating that the issue was first identified on (b)(6) 2011. The patient's home health nurse reported to the surgeon's office that the patient's wound was draining yellow purulent fluid. At that time, the patient was admitted to the hospital. Manipulation is not suspected as the patient is handicap and cannot reach her chest or generator site. The surgeon felt that issues were caused by tissue deterioration from an allergic reaction to the generator. Cultures were taken of the wound site and were found to be negative for growth. The lead and generator were both explanted on (b)(6) 2011. After the explant, the patient was sent home on antibiotics. The patient was then seen again on (b)(6) 2011 as her wound had re-opened and was again draining fluid. The patient was put on another dose of antibiotics however cultures were not taken. The nurse indicated that if the infection did not resolve they may have to admit the patient and administer stronger (intravenous) antibiotics to try to resolve the infection. There are currently no plans for replacement, however the surgeon did indicate that if they did chose to re-implant in the future, they may chose a different implant location. The nurse indicated that the issues were solely isolated to the chest area with no problems or infection in the neck. When the patient was seen on (b)(6) 2011, the neck incision was healing with no issues. The patient's generator model and serial number were also provided by the surgeon's office. The device history record was reviewed for the patient's generator and sterility was confirmed prior to shipment. During the follow-up with the nurse on (b)(6) 2011, it was reported that the patient's lead was extruding through the patient's chest wall. This event is reported under mdr number: 1644487-2011-02717.
 
Event Description
The explanted generator was received on (b)(4) 2015. Analysis has not been completed to date.
 
Event Description
It was reported that the patient was experiencing an allergic reaction to the metal used in the vns. Device explant was required, however the date of explant is currently unknown. Attempts for additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2012 an operative report from the day of surgery was received and indicated that the patient had "breakdown of her wound and then some drainage". She was not having a fever. The patient's generator and lead were explanted at that time and it was indicated that the tissue quality was "quite poor". It was also noted that hardware could be seen through the wound. It is unclear if the hardware that could be visualized was the generator or the lead. Additional information was then received on (b)(4) 2012 that the patient was healed and ready for implant, which then occurred on (b)(6) 2012.
 
Manufacturer Narrative

Event Description
Analysis was completed, and no anomalies were identified with the generator. The generator was left on after explant, and the generator was pulse disabled upon receipt. A battery life calculation estimated 0 years remaining battery life.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2293177
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dennis100
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« Reply #144 on: October 03, 2018, 07:07:19 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7741433
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dennis100
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« Reply #145 on: October 05, 2018, 12:33:03 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2018
Event Type  Injury   
Event Description
It was reported by a medical professional that a vns patient¿s incision had opened. After evaluation by the surgeon, it was believed the cause of the site opening was that the patient was having an allergic reaction to the sutures. The patient was scheduled for surgery to debride and restitch the wound. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842172
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dennis100
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« Reply #146 on: October 06, 2018, 05:12:27 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7863106
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dennis100
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« Reply #147 on: October 11, 2018, 06:41:30 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2618817
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« Reply #148 on: October 15, 2018, 11:41:35 AM »

Model Number 102
Event Date 07/25/2012
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
On (b)(6) 2012, a vns surgeon's coordinator reported that the vns patient was scheduled for an incision and drainage surgery on the chest wound on (b)(6) 2012 and her generator will be explanted at the same time. The patient's generator pocket/incision was infected/dehiscence. The patient had recently undergone battery replacement surgery on (b)(6) 2012. It was later discovered that the surgery was postponed until (b)(6) 2012. The surgeon plans on explanting the generator and then repositioning the lead, leaving it fully intact. The infection will be healed before the patient is re-implanted with a new generator. The device was explanted as planned. The surgeon believes that the patient picked at the sutures at the generator incision in the patient's left chest which caused the infection/dehiscence. Cultures were taken but the results were not provided. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2706616
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dennis100
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« Reply #149 on: October 25, 2018, 02:43:50 AM »

Model Number 103
Event Date 07/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, it was reported that, about one month prior, a surgeon explanted a patient's device due to infection. (the exact date of explant is unknown. ) the patient presented to the office with an open wound and exposed generator. The patient was reportedly doing great with seizure control, so replacement was anticipated once the patient was healed. A review of manufacturing records showed that the generator and lead were sterilized prior to distribution. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2724140
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