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dennis100
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« Reply #150 on: January 28, 2019, 05:57:05 AM »

Model Number 304-20
Event Date 05/01/2014
Event Type  Malfunction   
Event Description
Analysis of the returned lead portion was completed and confirmed an opening of inner tubing which exposed the conductive quadfilar coils. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the exposed surface and show what appears to be wear (smoothed surfaces) at the exposed portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
It was reported on (b)(6) 2015 that the patient is currently unhappy with the placement of the device. The physician referred the patient for a second opinion.
 
Event Description
The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Initially, it was reported that the patient experienced swelling and pain over the generator site. The patient was given antibiotics and the swelling resolved. It was reported that the patient was still experiencing pain at the generator site. The patient was seen for follow-up and it was reported that there was no infection and the patient was doing better. It was later reported that the patient was being shocked by the vns and that the device was interrogated and there were no problems. It was reported that the physician thought the patient's body may not be tolerating vns. It was reported that the patient wanted the device removed. It was later reported that the patient was experiencing shocks in his jaw and left arm and that the device was programmed off and the shocking resolved. It was reported that the patient would be scheduled for surgery to explore the lead. The patient's parents want the device explanted if nothing is found to resolve this shocking. The patient underwent lead replacement due to the increased discomfort over the last three months. The surgeon believed that the lead insulation directly under one of the tie-downs was worn away. The surgeon believes that the tie-down caused damage to the lead. It was later reported that the surgeon identified a break in the lead near the vagus nerve. It was reported that the patient's symptoms have completely resolved with lead replacement. The lead is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4128664
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dennis100
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« Reply #151 on: January 29, 2019, 08:00:21 AM »

Model Number 105
Event Date 08/04/2014
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Additional information was received stating that the vns patient underwent surgery to explant her device due to infection. The patient was later re-implanted with a new generator and lead on (b)(6) 2014. Review of manufacturing records confirmed sterilization for both the explanted generator and lead prior to distribution.
 
Event Description
The physician reported that the patient has an infection at the generator pocket since recent generator replacement. It was reported that there is fluid around the pocket and is swollen with an increased white blood cell count and fever. The physician also believes the infection has traveled to the lead at the clavicle area. The physician is considering explanting the generator and a portion of the lead as far up as can be reached without opening the neck incision. Once the infection is healed the patient will undergo reimplant. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4085399
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dennis100
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« Reply #152 on: January 31, 2019, 02:33:36 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2016
Event Type  Injury   
Event Description
Clinic notes were received for this patient's reported prophylactic replacement. The clinic notes stated that the patient complained of intermittent swelling and pain in her throat with trouble swallowing, where the issues with swelling and pain have been ongoing for at least 6 months. More recent clinic notes reported that this patient's vns is hurting their neck at the site of her vns lead, at all times. The patient also mentioned that they believed that their vns generator was migrating. It was also indicated that this patient is a smoker, smoking 11-20 cigarettes a day. Additional information was received from the doctor that it was unknown when the migration first occurred, and the migration is suspected, not confirmed. It is unknown what the cause of the suspected migration is, but it is a contributory cause to the patient's surgery referral. It was stated that the surgery for the patient's migration would be due to patient comfort reasons. It was unknown what the cause of the patient's constant pain at the electrode site was, but the pain was a contributory cause for the patient's surgery referral and it was stated that it would be both for patient comfort reasons and to preclude a serious injury. The cause of the patient's swelling in her throat was unknown, but the patient's difficulty swallowing was stated to be occurring with stimulation. The cause of the patient's difficulty swallowing was stated to be related to stimulation, and possibly related to the migration. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7854914
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dennis100
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« Reply #153 on: February 03, 2019, 04:00:21 PM »

Model Number 104
Event Date 10/20/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2014, it was reported that the patient¿s vns is protruding out of her skin and about 40% of it is exposed. There were clear signs of infection; swelling with yellow pus and is sensitive at the incision line but not surrounding areas. The patient¿s mother reported that it has been like this for 2-3 weeks and initially they covered it with a band-aid but it is now too painful to cover. The patient was referred to the surgeon. The surgeon stated that the patient scratched out her vns, which is why it is coming out through the chest and not at the original incision site. He admitted her to remove the unit and the lead wires due to infection. The surgeon removed the device on (b)(6) 2014 and noted there were no plans to re-implant as the patient had scratched the device out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4285570
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dennis100
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« Reply #154 on: February 06, 2019, 03:01:16 AM »

Model Number MODEL 250
Event Date 11/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the physician¿s handheld device was not functioning. The battery latch would not close and therefore the device could not be used. The wand was confirmed to not be causing or contributing to the issues. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned handheld device and flashcard were completed where no issues were found with the flashcard or associated software. During analysis of the handheld it was observed that the battery latch was functioning properly however the handheld device would still not power on. The cause for the inability to power on was due to a swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld device from powering on (this condition can also cause the handheld device to power off intermittently). Additionally it was identified that the main battery was unable to fully charge and power the handheld device for over 30 minutes. The cause for the anomaly is associated with a defective main battery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4347788
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dennis100
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« Reply #155 on: February 06, 2019, 03:02:28 AM »

Device Problem Migration or Expulsion of Device
Event Date 11/01/2013
Event Type  Injury   
Event Description
It was reported that the patient¿s left side of the neck is swollen from behind her left ear to down her neck, and that when she leans on her left side, she feels the battery sliding down underneath her axilla. It was reported that this has been going on for a year on and off and the welling would come and go. The patient reported that it started just prior to her cabg last year, but has worsened since that surgery. She said for the last week, it has remained swollen and she is coughing a bit of blood from her throat. The patient now wants the device removed. The patient saw a cardiologist and she doesn¿t have jvd, but the cardiologist stated that possible the lead was eroding the vocal cord area. The patient stated that she has had an mi and cva this past (b)(6) 2014. Per the patient¿s primary care physician, she does not need to see an ear, nose, and throat physician. However, the patient is still having neck swelling on the left side of her neck. Although surgery is likely, it has not occurred to date.
 
Event Description
Information was received from two of the patient's physicians. The first physician indicated the last device check was on (b)(6) 2015 showing normal battery status, normal lead impedance and no vns parameters were altered. The physician indicated that the patient has not reported any of the prior symptoms to him. The second physician indicated the last device check was (b)(6) 2015 and the device battery was indicated to be at end of service, lead impedance was ok and no parameters were changed. He indicated that that patient had reported dysphagia and throat pain but none of the other prior symptoms. No specific interventions were undertaken. Clinic notes were subsequently received for the (b)(6) 2015 office visit which indicated that the device would be replaced due to end of service. The notes indicated that the vns give her trouble with breathing but no specific intervention is referenced. The patient subsequently called the manufacturer and reported that her seizures were worse than before vns. The patient underwent pulse generator replacement on (b)(6) 2015 however high lead impedance was detected when the indwelling lead was connected with the new pulse generator despite repeated removals and insertions. The surgeon elected not to replace the lead during the surgery. Post-implant lead impedance also measured high. Lead impedance with the prior pulse generator was normal. Review of prior programming and diagnostic data reveals fluctuating lead impedance suggesting an intermittent short circuit condition. A battery life calculation using the available programming history showed approximately 0. 2 remaining until neos = yes. No known additional surgical interventions have occurred to date.
 
Manufacturer Narrative

Event Description
It was later reported that the patient has ¿burn marks¿ over her lead. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
The patient indicated that she feels her lead has moved, is wrapped around her esophagus, is choking her and causing throat pain. She stated that she has continuous voice alteration but no longer feels device stimulation since the time of her last interrogation 2 months prior. She stated she has coughs up blood and has a tight feeling in her chest. She stated that her generator is under her armpit. She indicated her neurologist will be speaking with her other providers, including her cardiologist, for clearance to replace her generator and lead. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
On (b)(6) 2015 the patient reported that he is having serious problems with the vns. The patient later reported that she is still having neck pain and swelling in the left side of the neck, feeling vibration and pulsing. She also stated that when she places the magnet over the device, she feels that stimulation is stronger. She also coughed up some blood.
 
Event Description
Operative notes containing a record of the pulse generator replacement on (b)(6) 2015, during which high impedance was observed following connection of the new generator to the indwelling lead, were received. The operative notes state that it was suspected that the high impedance measurement may possibly be due to emi from surrounding medical devices and was therefore left in place for interrogation in the postanesthesia care unit.
 
Event Description
Information was received indicating that the patient was scheduled for lead revision surgery. The patient subsequently reported that she was hospitalized due to multiple seizures and stated she was experiencing unusual seizures. The patient underwent surgery for the high impedance condition as reported and described in mfr. Report # 1644487-2016-00375.
 
Event Description
A provider reported that the patient called her to schedule an appointment to check on her vns which since (b)(6) (2015) is causing burn marks. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334258
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dennis100
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« Reply #156 on: February 06, 2019, 03:03:15 AM »

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

Event Description
Additional information was received that the patient had a fever of 103 degrees and experienced pain, swelling and tenderness at the vns generator implant site. One of patient's physicians prescribed antibiotics. The patient had an appointment with the neurologist on (b)(6) 2015. Follow up with the neurologist's office indicated that the patient has not been seen by the neurologist in 2015.
 
Event Description
It was reported that the patient believes she has an infection at the generator pocket. The patient reported that she is taking oral antibiotics and has not been to the implanting surgeon for evaluation. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4338701
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dennis100
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« Reply #157 on: February 07, 2019, 02:40:29 AM »

Model Number 302-20
Event Date 11/01/2014
Event Type  Injury   
Manufacturer Narrative
Device available for evaluation?, corrected data: no. The suspect device was not available for evaluation. Supplemental #2 report incorrectly reported that the device was for evaluation. Device evaluated by mfr? corrected data: not returned to mfr. The suspect device was not returned. Supplemental #2 report incorrectly reported that the device was returned.
 
Event Description
The generator reaching end of service was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the patient was seen by an ent and it was found that one of the leads is lying on the patient¿s vocal cord and causing redness and swelling. The patient was referred for a ct scan. It was reported that the physician would like the patient to undergo vns replacement. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient underwent generator replacement on (b)(6) 2014. Attempts for product return were made but the explanted generator has not been received to date.
 
Event Description
The explanted generator was returned on (b)(6) 2015. Analysis is underway but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4294419
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dennis100
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« Reply #158 on: February 08, 2019, 01:07:01 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/30/2018
Event Type  Injury   
Event Description
The infection was confirmed to only be at the generator site. The lead was reported to not have been removed.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Patient underwent vns generator explant due to an infection. The patient presented with post-surgical fever and edema in the thoracic region that was unable to be treated with antibiotics. A swab was collected from the generator and showed staphylococcus aureus. When the event was reported, it was noted that the implant facility was closed for an anvisa audit due to an increase in hospital infections. Review of the generator and lead device history records confirmed sterility prior to distribution. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8214393
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dennis100
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« Reply #159 on: February 09, 2019, 02:33:55 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced fits of screaming and crying upon the introduction of the auto-stimulation feature. The fits continued once auto-stimulation was turned off. The patient's generator was disabled, all output currents set to 0 ma, according to a company representative. It was reported that the patient continued to intermittently scream and cry when the device was disabled. It was reported that the patient's system diagnostics were within normal limits. It was reported that the patient's physician indicated that the increased output current may have caused inflammation or swelling. It was additionally reported that the adverse events began with the introduction of auto-stimulation and that the patient was prescribed steroids. A review of the manufacturer's device history records indicated that the generator passed functional specifications prior to distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8246320
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dennis100
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« Reply #160 on: February 09, 2019, 02:34:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2018
Event Type  Injury   
Event Description
It was reported by the patient that they experienced an allergic reaction following vns surgery and went to the emergency room. The patient indicated that they experienced severe swelling at the chest and neck site as well as difficulty breathing related to their allergic reaction. The physician indicated that the patient had a rash around the surgical sites related to the patient being allergic to the agent used to prepare the surgical site prior to surgery, chlorhexidine prep. The physician indicated that the patient was also allergic to the doxycycline antibiotics consumed. A review of the device history records showed that both the lead and generator were sterilized prior to distribution. No further relevant information has been received to date.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8251305
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dennis100
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« Reply #161 on: February 09, 2019, 02:35:12 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/12/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient presented with post-surgical fever, edema in the thoracic region and was treated with antibiotics without results. It was reported that the generator was explanted due to infection at the generator site. The hospital that performed the surgery has been closed due to an increase in hospital infection. Device history records were reviewed for the generator and lead. The devices passed all specification tests and were sterilized prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8233101
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dennis100
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« Reply #162 on: February 09, 2019, 02:36:18 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/17/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was hospitalized due to difficulty swallowing. The patient has since been discharged and is doing better. The physician believed that the difficulty swallowing was most likely the result of anesthesia and intubation during vns surgery. Clinic notes were received dated 12/31/2018. After the patient¿s generator was replaced, the patient was admitted to the hospital due to vomiting and gagging and remained hospitalized for 11 days. The patient had an increase in seizures and severe constipation as well. Per the physician's assessment, the patient had a similar response to t&a so it is unknown if this was due to anesthesia or due to swelling in the neck following surgery. Attempts were made to the physician for more information. Per the physician, the patient's increase in seizures was believed to be due to missing medications due to vomiting. The increase in seizures was above pre vns baseline. The cause of the vomiting was unknown if it was due to constipation/discomfort from vns surgery/presumed neck swelling. The anesthesia and medications may have also contributed. The vomiting started the day after vns surgery. The patient had improved as quickly as it began. The constipation was a chronic condition that was made worse by surgery, likely due to anesthesia and was unrelated to the vns. The patient's swelling was only presumed based on symptoms. The swelling of the neck was from the vns surgery and began on the day of the vns surgery. The device history records were reviewed for the generator and lead. They passed all specifications prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8272311
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dennis100
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« Reply #163 on: February 16, 2019, 02:50:04 AM »

Model Number MODEL
Event Date 02/19/2015
Event Type  Malfunction   
Event Description
The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway. The programming wand was also returned to the manufacturer. Product analysis was completed for the programming wand on 06/05/2015. The battery was not returned; consequently, an analysis of the battery condition could not be performed. Continuity testing of the serial data cable and the battery cable passed. After the battery was installed, the programming wand performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Event Description
Product analysis was completed for the handheld device on 07/01/2015. An analysis of the handheld was able to verify that the main battery was defective and unable to hold a charge. Once the battery was replaced, no further anomalies associated with the handheld performance were noted during testing. A swollen battery was confirmed, resulting in its inability to hold a charge for a minimum duration of 1-hour. Cause for the swollen battery is wear and age of battery. Product analysis was completed for the software flashcard on 07/01/2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the physician's handheld had a constant orange and green power light and that every time the handheld is powered on the user is prompted to calibrate the screen. A new programming tablet was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4601451
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dennis100
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« Reply #164 on: February 16, 2019, 02:50:58 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4600900
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dennis100
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« Reply #165 on: February 16, 2019, 02:51:53 AM »

Model Number 103
Event Date 02/09/2015
Event Type  Injury   
Event Description
It was reported that the patient's lymph node was swollen at the site of the electrode. The physician started the patient on prophylactic antibiotics in case the swelling was indicative of an infection. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the cause for the swollen lymph nodes was due to infection, but it is not known what the cause for the infection was. Planned intervention was to refer the patient to the physician and provide antibiotics.
 
Manufacturer Narrative
This information was inadvertently left off of initial mfr. Report.
 
Manufacturer Narrative

Event Description
The patient experienced dull pain and swelling at the electrode site on (b)(6) 2015 after the pulse width was increased soon after the infection occurred. The physician believed that this was an expected event because of the infection. The incision was reported to be well healed. There was no reported intervention for the infection after the antibiotics.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4592599
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« Reply #166 on: February 17, 2019, 06:17:52 AM »

Model Number 105
Event Date 01/26/2015
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the udi on the initial report.
 
Event Description
Product analysis was completed on the generator. The dhr shows that the pulse generator passed all specifications before it was released. 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.
 
Event Description
Additional information was received that the patient was not doing any better following a one month course of antibiotics. The neck incision site was still swollen, with an area that had a hard knot and appeared as though it had come to a head. No additional known interventions or re-implant have occurred to date.
 
Event Description
Additional information was received that the patient's lead was explanted on (b)(6) 2015 due to infection, which apparently had spread to the lead. Review of the lead device history record confirmed sterility and no non conformances were found.
 
Event Description
Additional information was received that the patient was on antibiotics for 14 days following the (b)(6) 2015 explant surgery due to infection. The patient was referred for re-implant but developed a cough and fever and the patient's caregiver noticed the chest incision site begin to bubble up again however it was reportedly not red or warm to touch. Thus, the patient went to the emergency room, where an x-ray was taken and it was stated that the patient had pneumonia and he was put on more antibiotics. No additional known interventions or re=implant have occurred to date.
 
Event Description
On (b)(6) 2015, it was reported that the patient was seen in the surgeon¿s office and an infection was observed at the chest incision site. The patient was scheduled for explant of the generator. The generator was explanted on (b)(6) 2015 due to the generator pocket infection. Operative notes were received from the (b)(4) 2015 explant surgery. It was noted that the skin incision was blistering on the lateral aspect and there was fairly thin fluid that was purulent/sanguinous coming out of the incision. No frank pus was found. The infected tissue was fully debrided and the generator was removed. The explanted generator was returned for product analysis on 02/26/2015. Product analysis is underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570484
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« Reply #167 on: Today at 01:26:20 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4565524
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