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dennis100
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« Reply #180 on: February 14, 2019, 02:10:13 AM »

Model Number 304-20
Event Date 02/18/2015
Event Type  Injury   
Event Description
It was reported that the patient underwent generator and lead replacement due to an infection. It was reported that the lead was rejected and that it is believed that the infection was caused by a bacteria that the patient brought to the operating room. Cultures showed staphylococcus aureus. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. Surgical notes indicate that the wound dehiscence is suspected to be caused by hypoproteinemia from neurological deterioration of the patient as the patient will not eat solid foods.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Analysis of the lead was completed on 04/02/2015. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on 04/06/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4636128
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dennis100
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« Reply #181 on: February 19, 2019, 03:41:28 AM »

Event Date 12/19/2011
Event Type  Injury   
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2418508
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dennis100
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« Reply #182 on: February 28, 2019, 03:28:17 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4883555
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dennis100
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« Reply #183 on: March 01, 2019, 02:27:24 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953442
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dennis100
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« Reply #184 on: March 01, 2019, 02:28:21 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949590
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dennis100
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« Reply #185 on: March 07, 2019, 02:00:18 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4964297
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dennis100
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« Reply #186 on: March 09, 2019, 02:43:20 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8311627
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dennis100
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« Reply #187 on: March 11, 2019, 07:58:30 AM »

Model Number 106
Event Date 08/28/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient's incision site had opened. Additional information was received that the patient's wound was re-stitched. No infection was noticed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5094043
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dennis100
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« Reply #188 on: March 12, 2019, 03:37:10 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5071307
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dennis100
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« Reply #189 on: March 13, 2019, 01:39:02 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5059042
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dennis100
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« Reply #190 on: March 14, 2019, 06:21:26 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5159327
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dennis100
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« Reply #191 on: March 16, 2019, 01:51:29 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7044768
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dennis100
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« Reply #192 on: March 18, 2019, 02:14:18 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5252502
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dennis100
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« Reply #193 on: March 20, 2019, 11:05:33 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5224608
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dennis100
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« Reply #194 on: March 21, 2019, 01:18:43 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5201164
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dennis100
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« Reply #195 on: March 22, 2019, 02:17:22 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5333113
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« Reply #196 on: March 23, 2019, 01:17:00 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5312729
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« Reply #197 on: March 24, 2019, 03:02:09 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5270831
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« Reply #198 on: March 29, 2019, 08:19:00 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5542272
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« Reply #199 on: April 04, 2019, 01:32:52 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5739981&pc=LYJ
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« Reply #200 on: April 05, 2019, 01:36:48 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5708741
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« Reply #201 on: April 05, 2019, 09:55:37 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8449326
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dennis100
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« Reply #202 on: April 05, 2019, 09:56:24 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8458088
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« Reply #203 on: April 06, 2019, 02:18:15 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387619
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« Reply #204 on: April 07, 2019, 03:06:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's incision had opened and that there was pus draining from the open incision. It was also reported that the patient's generator was visible. It was reported by the neurologist's office that the physician was unable to assess what caused the extrusion as it could have been related to manipulation, the infection, or inadequate wound healing. The patient's generator was explanted and their leads were clipped due to the infection. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No further relevant information has been received to date. Product return and device evaluation are not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8439540
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« Reply #205 on: April 07, 2019, 03:07:16 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8439742
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« Reply #206 on: April 24, 2019, 02:15:12 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6950577
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« Reply #207 on: May 01, 2019, 12:58:26 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6324817
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« Reply #208 on: May 05, 2019, 01:06:01 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6431341
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« Reply #209 on: May 08, 2019, 10:31:52 AM »

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

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