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dennis100
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« Reply #120 on: January 20, 2019, 03:14:14 AM »

Model Number 302-20
Event Date 07/08/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s office visit on (b)(6) 2014. The notes indicate that the patient was concerned about possible lead protrusion. The physician stated that lead impedance was within normal limits. It was reported that the patient went to the er on (b)(6) 2014 due to potential extrusion of the tie-downs. The extrusion was described as ¿blackhead-like things¿ that were extruding from the patient¿s neck. No issues with the device were observed. It was noted that the patient had some itchy spots at her clavicle. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. One set of electrodes appears to have been abandoned. Part of the lead was behind the generator and could not be assessed. There appears to be a sharp angle extending out from the medial portion of the generator. No clear lead breaks were found in the parts of the lead that could be assessed. A tie-down was visualized, securing the strain relief bend and loop. Based on the images provided, the reported extrusion of the tie-downs cannot be assessed or confirmed. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, the reported extrusion of the tie-downs cannot be assessed or confirmed.
 
Event Description
It was reported that the patient scratched the skin over the lead wires, but that there was no extrusion. The physician reported that there was no black spots present on the patient's skin related to vns. The physician believes that the patient scratched the skin due to device stimulation and that the area has been covered to discourage the scratching. The physician is considering decreasing the device stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3971748
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dennis100
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« Reply #121 on: January 28, 2019, 06:03:49 AM »

Model Number 302-20
Event Date 08/21/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Analysis of the lead was completed on 09/22/2014. Multiple breaks were confirmed in the negative coil of the returned lead portions. Mfr. Report # 1644487-2014-02711 will house the lead analysis. Analysis of the generator was completed on 09/25/2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Event Description
Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode. The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead. The result of this event is the pitting at the broken end of the coil wire. Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess. The adverse events reported here appear to be the result of the lead malfunction reported in mfr report #1644487-2014-02711.
 
Event Description
It was reported that the patient underwent an incision and drainage of a left scapular abcess and complete removal of the vns system. Both lead and generator were explanted. The explanted devices were returned for analysis. Analysis is underway, but has not been completed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

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dennis100
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« Reply #122 on: February 03, 2019, 03:47:16 PM »

Model Number 103
Event Date 05/01/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2013 it was reported that due to the patient's experience with irregular heart rhythms the cardiologist did an ablation. Following the ablation the patient began to have a low heart rate and a pacemaker was implanted. After having the pacemaker implanted the patient started to become dizzy, sleepy, with trouble eating (weight loss), and vomits with dizziness. It was also reported that the patient experienced their shoulder and neck tightening up when they swiped the vns magnet across the generator. Good faith attempts are currently being performed.
 
Event Description
Follow up with the physician found that he was not under the impression that the patient's complaints of experiencing irregular heart rhythms, dizziness (which led to vomiting), sleepiness, inability to eat (leading to weight loss), or tightening of shoulder and neck area were related to the patient's vns. The physician stated that the patient has had extended periods in which he was asymptomatic with his device turned on, and, conversely, he has reported the above symptoms with his device disabled. It is the physician's understanding that the patient is currently undergoing a cardiac workup to explore a cardiovascular etiology for his complaints. Lastly, the physician stated that as he believes none of the patient's problems are caused by his vns, he is unable to provide any additional information.

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dennis100
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« Reply #123 on: February 14, 2019, 02:17:34 AM »

Model Number 304-30
Event Date 11/23/2014
Event Type  Malfunction   
Event Description
Additional information was received that the patient is still experiencing ¿pulling¿ sensation and discomfort in his left neck area. The device is currently off.
 
Event Description
It was reported that, for the past 1. 5 months, the patient has had random episodes of sudden discomfort from the generator site up to the left side of his neck that is progressively worsening and occurs 5 times per day. The nurse practitioner has adjusted vns but the discomfort doesn't seem to reduce and might not be associated with the stimulation. The patient experiences discomfort when he is lying still, sitting, or standing, doesn't seem to have any trigger. Patient was contacted several times to visit the clinic to adjust vns or disable vns if needed. But patient has not been able to visit due to transportation issues. Patient was last seen in (b)(6) 2014 and patient was set to comfortable settings at that time. No issues were reported with the device during this visit. Patient has been provided with medications for the pain meanwhile. X-rays were received with a note stating that the patient has been complaining of severe neck pain that radiates into his left clavicle. The pain was reported to be independent of vns activation and he does have pain when he turns his head. Per the nurse practitioner, there is a possible mircrofracture of the lead and the vns was disabled. The patient¿s next appointment is on (b)(6) 2015. The x-rays were reviewed and there did not appear to be any lead discontinuities in the portion of the lead that could be visualized. It was noted that the strain relief bend did not appear to be present. The lack of strain relief bend could possibly be a factor in the patient¿s pain. However no conclusions can be drawn regarding the exact cause of the pain. Attempts made for the diagnostic test results were unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
Additional information was received that the patient's device diagnostics were checked on (b)(6) 2015 and that the results were within normal limits. It was also reported that the patient's pain was slightly better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4639353
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dennis100
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« Reply #124 on: March 20, 2019, 11:10:12 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/02/2013
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient had been experiencing pain at both the generator and lead sites since initial implant and before the device was even programmed on. The device was checked and device settings were increased during the office visit and the patient tolerated the procedure well. Additional information was received stating that the patient passed out due to pain on (b)(6) 2015. Following device disablement on (b)(6) 2015, the patient has not reported any further pain and syncope events and does not have a history of syncope. The patient device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Follow-up revealed that the painful stimulation was occurring in the left neck.
 
Event Description
Additional information was received from the patient stating that despite device disablement, the patient was still experiencing pain in his neck when moving his head/neck and that there was swelling at his neck/shoulder area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5208395
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dennis100
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« Reply #125 on: April 06, 2019, 01:48:45 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/28/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for a generator and lead replacement due to high impedance and painful stimulation in the left shoulder area. The patient's output current was decreased due to the painful stimulation. It was reported that there was no known trauma or manipulation to the area to contribute to the high impedance. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8448215
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dennis100
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« Reply #126 on: April 16, 2019, 01:12:29 AM »

Model Number 302-20
Event Date 08/14/2014
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2014. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. The device was programmed off on (b)(6) 2014. The physician's office was notified of the high impedance event and the manufacturer's recommendations when high impedance is observed. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing pain in his left jaw, neck and shoulder during the visit when the high impedance was observed. The physician then disabled the device in response to the pain. Due to the diagnostic results observed during the visit, it appears that the pain was related to the lead fracture. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: outcomes attributed to adverse event; this information was inadvertently left off on mfg. Report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5970450
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dennis100
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« Reply #127 on: April 29, 2019, 05:58:15 AM »

Model Number 300-20
Device Problem High impedance
Event Date 01/26/2017
Event Type  Malfunction   
Event Description
It was reported that a patient's device had high impedance. The patient recently began experiencing painful stimulation and an increase in seizures. The patient was scheduled to undergo a full revision surgery due to high impedance. It was also reported that the patient experienced coughing with increases in stimulation, but it is unclear whether the coughing had always occurred with stimulation or began with high impedance. The patient's increased seizures were occurring approximately once a month. X-rays were reviewed for the patient. It was difficult to assess whether the lead pins were both fully inserted inside the connector blocks due to the angle of the images provided; however, it appeared that neither of the two lead pins were fully inserted inside the connector blocks. Additionally, it could not be determined whether the feedthrough wires appeared intact. No gross fractures were observed, and no sharp angles in the lead were identified. The presence of a microfracture and/or lead discontinuity could not be ruled out. The patient¿s high impedance was likely due to incomplete pin insertion of both of the lead pins. Programming history was also reviewed, but there were no diagnostic results available. No additional information has been provided to date. No known surgical intervention has taken place to date.
 
Event Description
It was reported that high impedance was observed on the patient's device during surgery. A kink in the patient's lead was believed to be the cause of the high impedance, but the high impedance did not resolve when the lead was straightened out. The surgeon decided to proceed with a full revision. It was reported that the patient's increase in seizures was above his pre-vns baseline. The patient was reportedly experiencing painful stimulation in his left neck and shoulder, and the coughing that occurred with settings increases was not seen prior to the high impedance. The lead was discarded by the hospital, and the generator has been received; however, analysis on the generator has not been approved to date. No further information has been provided to date.
 
Event Description
Analysis was approved for the generator. Visual examination did not identify any anomalies with the generator. In its as received condition, the generator communicated normally. During the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Product analysis did not confirm the end of service allegation and concluded that there was no abnormal performance or other adverse condition with the generator. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6347523
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dennis100
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« Reply #128 on: May 11, 2019, 02:03:50 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/07/2018
Event Type  Injury   
Event Description
It was reported that the patient had swelling in their neck since surgery that has not gone away. The patient¿s wife reported that the swelling is filled with fluid and is really mushy, and goes from collar bone to his neck. The patient¿s neurologist had determined the swelling was not related to vns stimulation. Per the patient¿s neurologist, the reason for the swelling was not known. The patient was referred for replacement of their lead. Attempts for information from the surgeon have been unsuccessful to date. Device history records were reviewed for the devices. The device was sterilized and passed all specifications prior to distribution. Surgery is likely but has not 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=8473236
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dennis100
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« Reply #129 on: June 01, 2019, 03:34:35 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
Event Type  Injury   
Manufacturer Narrative
Device evaluated: 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 felt his generator move and then experienced a ¿shooting¿ pain. It was believed the pain was related to the device position. The patient¿s generator stated to have moved higher and toward the shoulder about a year prior due to significant weight loss. The patient was lying on his side that was causing soreness. The patient was prescribed pain medication, and the patient¿s surgeon decided to move the device lower in the patient¿s chest to try to alleviate the pain. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6730942
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dennis100
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« Reply #130 on: June 02, 2019, 07:29:17 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2017
Event Type  Injury   
Event Description
A patient was admitted to the hospital after experiencing sinus bradycardia, tachycardia, and syncope. The patient's family doctor, who did not manage the patient's vns, did not believe that the arrhythmias and syncope were related to vns; however, the medical staff at the admitting hospital wanted to monitor the patient to understand whether there was a relationship between the arrhythmias and syncope to vns. Both the medical staff and family doctor believed that the syncope was potentially related to the bradycardia as it occurred when the position rose to a standing position after sitting down. Monitoring determined that the patient's bradycardia was constant during both vns stimulation on and off times. According to the nurse at the admitting hospital, the patient had previously been admitted to another hospital for nonsustained ventricular tachycardia three years prior to the recent arrhythmias. The patient's resting heart rate was reportedly 54 beats per minute. Device diagnostics were performed and returned results within the normal limits. Additionally, the patient reported that her vns settings had not been changed by her prescribing psychiatrist in over 5 years. The attending nurse later reported that she believed that the patient's blood pressure medication was adjusted during the hospital, but she did not know of the cause of the arrhythmias and syncope or their relation to vns. No further relevant information has been provided to date.
 
Event Description
Clinic notes were received from the patient's er visit that indicated that the patient was admitted to the hospital after experiencing cardiac-related chest pain that was unrelieved by nitroglycerin. The patient's resting heart rate on intake was 51 beats per minute, and her blood pressure was 104/70, which was indicated as within the normal limits. The chest pain radiated to the patient's left arm and shoulder. The patient was noted to be bradycardic. X-rays taken on the day of admission showed cardiomegaly, but there was no evidence of that condition observed in x-rays the following day. Per the clinic notes, the vns was interrogated and observed to be at neos = no with diagnostic results within the normal limits. The vns was disabled via magnet inhibition while the medical staff attempted to discern the relation of the vns to the patient's bradycardia. The medical staff later assessed that the chest and left arm pain were caused by the patient's beta blockers. The patient's medications were adjusted several times during the hospital stay. The chest pain appeared to resolve after a change to new medication, and the patient was discharged from the hospital in stable condition. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685193
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« Reply #131 on: June 04, 2019, 08:12:38 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2006
Event Type  Injury   
Event Description
It was reported by the caregiver that the patient's implant site was so swelled up after the generator replacement surgery that the patient was hospitalized overnight, even though it was originally supposed to be an outpatient procedure. The caregiver reported that a week later it was still swollen and they stuck it with a needle, expecting fluid to drain out, but nothing came out. The caregiver stated that the surgeon had "no idea what the swelling was about and to this day doesn't know".
 
Manufacturer Narrative
Report source, corrected data: initial report inadvertently selected other and input 'caregiver' instead of selecting consumer.
 
Event Description
It was reported via clinic notes that after a period of time following the surgery, fluid was extracted from around the wound site and was sent to the lab for evaluation of the cultures. It was noted that the swilling was nonpurulent and there was no drainage nor had the patient been having any fever. Clinic notes from a later date indicated that both incisions were in very good condition and there was no fluctuance, redness, or apparent tenderness. The surgical notes indicated that the incision sites were irrigated with bacitracin solution.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #01 inadvertently left out the information regarding the reported hematoma. (b)(4).
 
Event Description
The clinic notes received also contained notes from a second physician that indicated that the patient had a hematoma that was beneath the patient's skin, not the pectoral muscle, that was still quite apparent. It was noted that the yellowish discoloration had spread over the chest, down to the left elbow and over the clavicle. It was noted that the hematoma area was fluctuant, but did not feel hot and was not tender. The physician attempted to aspirate the area was only able to aspirate only 2 to 3 cc of blood, which was sent for culture. It is unclear if the reference of swelling from one physician was the same as hematoma referenced by the second physician.

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« Reply #132 on: June 07, 2019, 05:21:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Event Description
It was reported by the patient that she has continuous pain in her chest and shoulder, and wanted a smaller generator. The patient was referred for replacement. The patient was replaced due to battery depletion. The generator has not been received by livanova 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=8574255
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« Reply #133 on: June 27, 2019, 12:20:59 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for patient's generator replacement referral. Per notes , the physician noted tenderness on the chest wall when the vns was interrogated. Case manager contacted the neurologist office for the reason for the referral and mentioned that the surgery may just be repositioning surgery for the pain in the chest. At the surgeon's consult appointment, the surgeon mentioned that the patient was ok. The surgeon has deferred repositioning the device. No known surgical interventions have occurred to date.
 
Event Description
Patient was seen by the surgeon for evaluation of neck symptoms as there was a question as to whether these might be related to an existing vagal nerve stimulation. Patient reported intermittent arm numbness, episodes of shaking and pain that seems to radiate from the shoulder and left arm downward she also intermittently describes left arm weakness. The physician indicated that these events sound a lot more like radiculopathy-cervical disc disease than it does anything to with vns device. The surgeon was pessimistic that removal of the device would change symptoms at all and recommended the patient to see someone who specialized in spine disc disorders. The physician reported that the surgery was not planned for the pain. The pain began in (b)(6) 2018 and the cause is suspected to be musculoskeletal reason. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7318737
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« Reply #134 on: July 14, 2019, 04:35:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received from a visit dated (b)(6) 2018 providing the patient will have a pocket revision due to pain as an x-ray showed the generator has migrated. The patient explains the pain began in (b)(6). It was also noted the patient feels shortness of breath and numbness into her left shoulder and arm. Impedance on (b)(6) 2018 showed impedance within normal limits. Follow-up from the provider indicated the patient states the vns had moved after being placed. Generator replacement surgery. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7747257
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« Reply #135 on: August 10, 2019, 01:18:54 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was referred for generator replacement. Within the clinic notes, information was received that the patient experiences pain related to stimulation in their left neck, chest, and shoulder, as well as pain when their lead is palpated. Additionally, the notes mentioned that the patient suffers from left vocal cord paralysis. The clinic notes detail that the patient experienced shingles, not alleged due to the vns, and that the patient believes the shingles "messed up her device" since the reported pain did not occur until after the patient experienced shingles. Within the clinic notes the surgeon informed that the patient's symptoms and the device are not likely associated, but that the device did need to be assess to ensure that it was not causing other symptoms. It was reported in clinic notes that the device was previously checked, and that the impedance was within normal limits and the physician made no changes to the patient's settings. Additional information was received that the physician indicated that the patient's referral for replacement was due to pain. The neurologist's office indicated that the device removal due to pain is for patient comfort reasons. However, no additional information was received in regards to the vocal cord paralysis, and its relationship to the surgery referral and pain. No surgical intervention has been reported to date. No additional relevant information has been received to date.

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« Reply #136 on: September 06, 2019, 10:51:04 PM »

Model Number 1000
Device Problem High impedance
Event Date 08/02/2019
Event Type  Malfunction  
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.
 
Event Description
It was reported by the physician's office that there was a high impedance with a patient's sentiva generator. Information was later received from the sales representative that she spoke with the physician regarding the high impedance. She stated x-rays were performed and there were no visible lead breaks found. She said that it was reported the patient had discomfort in shoulder due to the high impedance. During follow-up attempts with the physician, it was stated the device was interrogated with the patient in different positions to rule out a positional fracture. The physician also re-assessed the reported shoulder pain and indicated this was not related to vns and there was no longer any shoulder pain. Ap chest and neck x-ray image was received and reviewed. The generator placement was determined to be normal in the left chest. Based on the scope of the image, the feedthrough wires were intact and the tip of the pin could be visualized past the second connector block. The lead was visualized in the chest and neck. A strain relief bend could be visualized per labeling; however there was no strain relief loop and tie downs were not placed per labeling. Based on the scope and quality of the image, it appears the lead is routed behind the generator. The lead wires appeared to be intact at the connector pin. The lead was assessed for fractures and no gross fractures or discontinuities were noted. Based on the x-rays received, the cause for the high impedance cannot be determined at this time, however incomplete pin insertion can be ruled out. The presence of a fracture or micro-fracture in the lead cannot be ruled out. The device history record's of the generator was reviewed. The generator passed final quality and functional specifications prior to release. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed. Additional investigation is underway. No additional relevant information has been received to date.

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« Reply #137 on: October 12, 2019, 01:24:15 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via clinic notes received that the patient was experiencing painful stimulation in her chest and neck, which was like an "electrical zapping feeling" and was bothersome. The patient denied any sign of infection or trauma to the chest or neck. Chest x-rays were reviewed by the physician and were reported as normal. The vns was disabled and the symptoms resolved. However, the vns was then programmed back on to lower settings (normal mode output current lowered from 1. 75 to 1. 50 ma) and it was noted that the patient tolerated it well. Within a few hours, the patient felt more shocking sensations and the vns was disabled. The patient presented a week later stating that she had started getting sharp pains again over the weekend and chose not to go to the er. The pains occurred every 30-40 minutes (vns settings were 30 seconds on, 5. 0 minutes off). It was stated that the patient did not feel any vns type stimulation and that she felt a sharp stabbing sensation that would last for a second and then go away. Associated pain radiated up to her neck and the patient also experienced a sensation of heaviness. The patient's left should also hurt and when laying on the left side, this appeared to result an in increase in the shocking sensation. Cardiology stated that all tests were within normal limits. The device was disabled. The physician discussed options with the patient, who elected to go for vns generator replacement. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8971264
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