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dennis100
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« Reply #630 on: June 08, 2019, 06:50:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that since the patient's battery replacement surgery, she was experiencing neck pain. It was stated that right before her battery change due to battery depletion, she had a large seizure where after she felt a "pull in her neck". Since then, there had been a "lump" in her neck and pain with stimulation. She was going to obtain x-rays. There was no reported impedance issue. The patient stated that the vns helped her for years and that she would prefer to keep the device controlling her seizures rather than having it turned off for the pain. The physician did not know the cause of the lump and believed that an exploratory surgery or revision may be needed to know. It was clarified that this surgery would be for patient comfort, and not to preclude a serious injury per the physician's assessment. Diagnostics were indicated to have been within normal limits with ok battery life. X-rays were received for review. The connector pin was seen coming through the second connector block, indicating complete pin insertion. Based on the images provided, the cause of the painful stimulation could not be determined. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Clinic notes were later received. It was stated in the notes that the patient experienced painful stimulation, mainly in her neck, but associated with dysphagia, hoarseness, chest pain, and shortness of breath. The events are non-radiating and only occur with vns stimulation. The pain became so significant that the "voltage" (likely referring to output current) had to be decreased, with increased dosages of seizures meds and pain meds. It was stated that since decreasing settings and increasing meds, the patient stated that she was still getting 2-3 grand mal seizures per week. Further updates were received and the patient reported that she was "now having 2-3 seizures per day" and has very painful stimulation for which she is on medication for. Output current and duty cycle were lowered for the pain. The vns surgeon and breast surgeon agreed to wait to schedule vns surgery until after the patient's mastectomy. No known vns surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8621049
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dennis100
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« Reply #631 on: June 09, 2019, 01:51:28 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/16/2017
Event Type  Injury   
Event Description
It was reported that the patient woke up one day and was experiencing severe pain in the chest and neck. There was no known trauma to the vns and the neurologist didn't know what the cause was. The patient's settings were lowered and x-rays were ordered. Clinic notes indicated the patient patient's mother had called and reported that the patient was having severe chest pain and the patient was given fentanyl en route. A chest x-ray was unremarkable. A neurologist disabled her normal mode output current. Post pain medications and device disablement , the pain went away with no recurrence. The pain appeared to be prominently in the left side of the chest but also went into her neck and lower trunk region. The patient's mother indicated that the patient's pain was cyclical. There was no recent trauma to the head, neck and chest, and no patient manipulation. When the vns was turned on to 0. 5 ma the patient began to experience pain again, and her device was re-disabled. It was believed that the patient's pain was related to stimulation. The patient's device was reportedly working properly with good impedances. The physician believed that the patient's generator and leads may need to be replaced. The pain was reported to be serious. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
The patient's generator and lead were replaced. The explanted products were discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6858790
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dennis100
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« Reply #632 on: June 10, 2019, 01:19:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury   
Event Description
It was reported by the physician's office that the mother reported the vns generator was making the patient sick and causing discomfort. There was also painful stimulation reported. The patient underwent vns generator replacement surgery. The explanted generator has not been received by the manufacturer to date. Follow up with the company representative revealed that the patient did not show for his follow up appointment. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6984350
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dennis100
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« Reply #633 on: June 12, 2019, 03:11:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury   
Event Description
Clinic notes were received for generator replacement referral. Per notes, the patient reported that she feels her vns has been more painful lately, and wonders if it is not working any longer. At the previous clinic visit, she mentioned that her vns was not firing off for a couple hours (normally, she can feel it firing). It was reported to be working ok since then up until past two weeks, when she has been feeling pain in her left chest area, under her armpit, especially when the device fires. Patient also feels a wire present near the attachment to the device which was not noticeable to her previously. Patient has not had any injuries or falls which may have damaged the device. Patient compares this to a similar feeling she had before the batter was replaced previously. Patient's device was interrogated but no adjustments were made. The patient consulted with a surgeon who indicated that a generator replacement is recommended. The lead impedance was normal and so lead replacement is not needed. Impedance - 2424 ohms. The surgeon noted granulation tissue or lead wire close to the skin in the chest area. The incision was however well healed. No other relevant information was received. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the surgery was for patient comfort. There were no causal or contributing factors that preceded the painful stimulation and the report of erratic stimulation. The reported protrusion was confirmed invalid and thought to be patient's perception. There was no wires on exam like reported. Patient's settings were provided but diagnostics were not. The patient underwent generator replacement surgery. The explanted device was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6949677
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dennis100
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« Reply #634 on: June 15, 2019, 11:45:19 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2008
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's generator and lead would be explanted due to lack of efficacy. The patient was explanted. While following up with the office, the nurse read from the clinic notes that the patient was explanted because they had no clear benefit from the vns, the vns was causing the patient pain in the neck, and the device was turned off. The nurse could not clarify whether the explant was due to patient pain or just for lack of efficacy. The suspect product has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device available for evaluation?, corrected data: the initial report inadvertently omitted that the products were received. Describe event or problem, corrected data: the initial report inadvertently omitted that the products were received.
 
Event Description
It was reported by the physician that the patient's pain in neck was not the reason for explant. The pain reported was painful stimulation for which the patient's vns was disabled in 2010 for patient comfort. The explanted lead and generator were received. Product analysis was completed on the returned lead portion. The electrodes and part of the lead body were not returned so could not be evaluated. Product analysis identified an abraded opening in the lead outer tubing that caused fluid leaks into the outer tubing. However, product analysis found no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the patient's painful stimulation. The lead performed according to functional specifications with no obvious anomalies identified. Product analysis has not been completed on the returned generator, to date. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned generator. The generator was monitored for 24 hours in a simulated body temperature environment. The generator provided the intended output current for the entirety of the monitoring period. A comprehensive electrical evaluation showed that the device performed according to functional specifications. No anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042545
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dennis100
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« Reply #635 on: June 15, 2019, 11:46:46 PM »

Model Number 302-20
Device Problems Detachment of Device or device Component; Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was complaining of sternal pain with stimulation. However, the vns settings were lowered in steps and eventually disabled with no relief. The vns was programmed back on. The patient was referred for prophylactic vns generator replacement. Clinic notes were later received that indicated that the patient's pain was just below the site of his vns generator and was sharp with some mild radiation down the chest. Over the counter pain medication had limited effect and the patient was prescribed a topical lidocaine. Imaging was reviewed by the physician's office, but not the manufacturer, and no gross issues were noted. The patient was then referred for full vns replacement surgery per the clinic notes. The patient underwent only vns generator replacement surgery. The explanted generator was received by the manufacturer and is pending product analysis. It was later reported that the patient was still experiencing pain after the vns generator replacement surgery. The patient reported that for two days postoperatively, there was no pain, but shortly after, the patient began to experience the pain again. The pain was not associated with vns stimulation, but the patient reported that it was a tingling sensation that radiated into his neck. It was noted that the incision from the generator replacement surgery was well healed. There was no indication of damage on the lead during the vns generator replacement surgery. However, the patient is being referred for vns lead replacement surgery to attempt to alleviate the pain. No additional relevant information has been received to date.
 
Event Description
Product analysis was completed on the explanted vns generator. Proper functionality of the vns generator was confirmed in the product analysis, or pa, lab. The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours. No variations in the output signal were observed and the generator provided the expected level of output current. The generator performed according to functional specifications. The generator communicated normally and no eri flag was set "as received. " there were no abnormal performance or other adverse conditions found with the generator.
 
Event Description
The explanted lead was received by the manufacturer, indicating that the patient underwent lead replacement surgery, and is pending product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7030468
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dennis100
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« Reply #636 on: June 17, 2019, 04:32:58 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2002
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's device was disabled due to painful stimulation in the left side of neck face and left arm. Since generator replacement, the patient also had pain due to position of device. Diagnostics of the device indicated normal device function and x-rays were taken. The patient therefore requested for device explant and the device was explanted. The device history records were reviewed and the records indicate that both the generator and lead passed all tests and inspections prior to shipment. The explanted devices were not received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7143656
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dennis100
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« Reply #637 on: June 18, 2019, 01:09:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The surgeon reported that the patient was having pain at the implant site. The surgeon stated that everything looked good and that the generator was sitting well in the pocket, and that the wires seem to be intact and correctly located. The patient felt the pain at the electrode site during stimulation and described it as a shocking sensation during magnet stimulation. The doctor believed the patient was doing well and there were no issues with the generator or lead. Diagnostics were within normal limits and the settings were felt not to be contributory to the patient's pain, but the patient was complaining of pain at the generator site. The patient has been referred for surgery. No known surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
Surgery has been completed for this patient's generator replacement. The product has not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
Additional information was received that the explanted product is held for 2 years and 3 months by risk management at the explant facility before the product will be returned to the manufacturer. The product has not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7154501
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dennis100
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« Reply #638 on: June 18, 2019, 01:10:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient's mother reported that a patient received stronger stimulation with a magnet swipe. The magnet stimulation reportedly made the patient's seizure worse. No additional relevant information has been received to date.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial report inadvertently did not include known medical intervention describe event or problem, corrected data: initial report inadvertently did not include known medical intervention and full list of patient events event problem codes, corrected data: initial report inadvertently did not include full list of patient events. Report source, corrected data: initial report inadvertently did not include consumer. (b)(4).
 
Event Description
It was reported that the patient swiped her magnet again after a dosing appointment where her settings were increased, and she experienced a head tilt to the left, a cold sensation, shaking, painful stimulation, nausea, and pallor with magnet stimulation. This reportedly occurred a few more times, but each time was less intense; however, these events made the patient afraid to use her vns magnet. A company representative and the physician met with the patient and her mother. During the clinic visit, the patient's magnet pulse width setting was reduced from 500 to 250 microseconds. The patient was then able to tolerate stimulation, and the events resolved. Diagnostics were within the normal limits. Use of the magnet had made the patient anxious since she reportedly did not expect to feel stimulation as strongly as she did following the initial settings increase. The physician believed that the reported events the patient's anxiety contributed to the adverse events she experienced with magnet stimulation. Stress was also a trigger for the patient, so the physician believed that the combination of original settings and the patient's anxiety also contributed to the change in seizure intensity. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7122957
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dennis100
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« Reply #639 on: June 18, 2019, 01:11:36 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 10/24/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that low impedance was observed on a patient's vns. A manufacturer representative followed up with the patient about a month later and ran system diagnostic tests. Low impedance was still seen. The patient reportedly denied having any recent injuries or trauma that could have damaged the lead. The physician increased the patient's settings where she reportedly felt a noticeable difference. She also had voice alteration at the higher settings. This indicated some stimulation was still being delivered to the vagus nerve despite the low impedance. A review of the device history record indicated the lead had passed all quality inspections prior to being release for distribution. No surgical intervention has occurred and no further relevant information has been received to date.
 
Manufacturer Narrative
Adverse event or product problem, corrected data: initial report inadvertently did not check adverse event. (b)(4).
 
Event Description
Further information was received from the patient's physician that there was no indication of any trauma or manipulation that might have occurred which could have led to low impedance. When the patient was seen on the day low impedance was first seen, the patient reportedly had discomfort in her throat with stimulation. The patient was reportedly seen at a later date. The system diagnostic test run on this day showed an impedance value within normal limits. There was no data available in the programming history for review and no additional data has been reviewed to date. No further relevant information has been received to date and no surgical intervention has occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7138842
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dennis100
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« Reply #640 on: June 18, 2019, 01:12:44 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 11/23/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A patient's device was causing him discomfort. High lead impedance was observed on the patient's device. The patient also reportedly had an external skin wound that may have been caused by the vns. The patient's device was programmed off in response. X-rays were performed and reviewed by the physician and reportedly did not identify a lead break or other abnormality. A company representative reported that the pain may be a result of stimulation. The physician suspected that the patient's wound had become infected. At a subsequent visit, the patient's wound had improved significantly since the device was disabled. The company representative confirmed this via assessment of updated pictures of the wound. The patient was given antibiotics. Lateral neck x-rays of the patient's device were reviewed by the manufacturer. Only a small portion of the lead was visible in the images, and the generator was not visible in the x-ray images provided. The lead was observed in the neck. The strain relief bend was present, but a strain relief loop did not appear to be completed. Two tie-downs appeared to be securing the lead past the strain relief bend. No sharp angles or discontinuities were observed in the images. Ap neck and chest x-rays and lateral chest x-rays were later reviewed by the manufacturer. Due to the angle of the generator in the image, proper lead pin insertion could not be assessed. The filter feedthru wires appeared intact. The lead was observed in the neck, and the electrodes appeared to be placed per labeling. The strain relief bend was present, but a strain relief loop did not appear to be completed. No sharp angles or discontinuities were observed in the visible portion of the lead. A portion of the lead was routed behind the generator and could not be assessed. The cause of the patient¿s high impedance could not be determined with the x-ray images provided. The device history records were reviewed for the lead and generator and revealed that both devices met all sterilization and functional specifications for release prior to distribution. The physician did not believe that patient manipulation of the device caused the external wound and infection. The patient was referred for surgery to resolve the high impedance, but no surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent exploratory surgery. It was determined that fluid was observed in the lead, causing the surgeon to suspect a lead fracture. High impedance was observed on both system and normal mode diagnostic tests. The patient was referred for lead and generator replacement surgery, but no additional surgical intervention has 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=7132107
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« Reply #641 on: June 18, 2019, 01:13:33 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2015
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient had issues with a lead pulling sensation. The patient had a revision surgery to loosen up the lead for more range of motion for the patient and it was noted that the patient had fibrosis around the lead. No additional relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem - corrected information: the information included in describe event or problem on this report should have been included in the initial report as the surgery for the patient was due to the all of the adverse events reported for the patient. Relevant tests/laboratory data - corrected information: the settings and diagnostic data should have been included in the initial report. (b)(4).
 
Event Description
Information should have been included in the initial report that the patient also had painful stimulation and muscle spasms in the neck at the electrode site. The spasms in the patient's neck subsided when the vns magnet was placed over the generator to disable it. The patient's settings were adjusted multiple times and the normal and systems diagnostics were stated to be ok. The painful stimulation and muscle spasms were stated to not have resolved after the surgery to reposition the lead indicating that the surgery could have been to help alleviate those adverse events as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7155729
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« Reply #642 on: June 18, 2019, 01:14:21 AM »

Model Number MODEL 3000
Device Problems Energy Output To Patient Tissue Incorrect; Improper Device Output
Event Date 11/08/2017
Event Type  Malfunction   
Manufacturer Narrative
Software version 1. 0.
 
Event Description
It was reported that the patient was experiencing painful stimulation that occurred when the magnet was swiped. The patient only started experiencing this pain since the most recent adjustment, made with the m3000 programmer. The patient was told to stop using the magnet, until their settings could be adjusted by the doctor. The patient was seen 3 weeks later to reprogram their generator using an older programming system. The magnet current was reduced to help with tolerability. System diagnostics were run and were within normal limits. The patient felt much better about the settings after this appointment. These events have been determined to be due to software error in the m3000 programmer that causes certain parameters to be incorrectly calculated in m106 generators. These incorrect calculations along with a combination of programmed settings, magnet swipes, and autostimulation may lead to a period of continuous current ramping for part or all of an entire therapy burst. During this ramping, the current can exceed programmed values. This is likely the cause of the patient's reported painful stimulation. To resolve this issue, the patient's settings were reprogrammed to avoid this problem. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7133752
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« Reply #643 on: June 19, 2019, 04:16:48 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/11/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient was observed overnight at the er complaining of painful stimulation. And continuous stimulation. The mom said she was feeling burning in her head. The physician requested the device to be turned off. Follow-up to the physician at the hospital provided that use of the magnet to disable the device was tried and did not resolve the issue. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the patient¿s caregiver on (b)(6) 2018 provided that the patient was in the er again due to painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7092861
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« Reply #644 on: June 19, 2019, 04:17:54 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/13/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
Report received that a patient had pain at the generator incision site. The physician later indicated that he believed the generator was positioned too laterally. However, there was no indication that it had migrated from its original position. Further information was received that the patient presented with episodes of pain which reportedly spread to the left neck. He also had coughing. Both of these events reportedly occurred with stimulation. The physician indicated that he believed this was indicative of a malfunction of the generator. The patient was referred for surgery, although it was not stated whether it was a planned pocket revision or full vns revision. The vns was turned off. The physician's notes indicated that a "lead test" was performed and results were ok. However, impedance value was not noted. No further relevant information has been received to date.
 
Event Description
Further information was received that the patient experienced both painful stimulation that occurred "several times a day" and pain in the chest. The physician reportedly did not know whether the generator had migrated. The physician did not know the cause of the pain and painful stimulation and if the two events were related to the possible migration. The impedance value from the clinic visit where the patient first reported the adverse events was provided. It was within normal limits. Further information was received that the patient was seen by the surgeon. The surgeon determined that a revision was not necessary because the main source of the patient's pain was from the stimulation. This was able to be controlled by decreasing the vns pulse width. The surgeon did confirm that the device may have migrated outside of the pocket, but remained in a good place and was not a contributing factor to the painful stimulation. Information from the implanting surgeon indicated that non-absorbable sutures were not used to secure the generator in the pocket at the last replacement. No further relevant information has been received to date. No further relevant intervention has been taken to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7102536
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« Reply #645 on: June 21, 2019, 01:00:38 AM »

Model Number 302-20
Device Problem Fracture
Event Date 11/09/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on the patient's device. It was also stated that the patient experiences pain during stimulation at times in the neck and chest. The patient was referred for consult with the surgeon however no surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received from the physician that the high impedance was observed upon interrogation of the vns device during a clinic visit. It was stated that the patient constantly touches the unit which could be a potential cause for the observed high impedance. The patient had a full revision surgery and the explanted lead and generator were returned for analysis however analysis has not been completed to date. On the date of replacement the impedance was noted to be ok however based on the position of the patient it could have shown to be ok so the device was replaced regardless.
 
Event Description
Product analysis was completed on the returned generator and lead. Generator analysis revealed there were performance or any other type of adverse conditions found with the pulse generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Lead analysis was completed. The lead was returned in one piece which did not include the electrodes. There were two set screw marks noted on the connector pin indicating that at one point in time proper contact existed between the set screw and the connector pin. The negative coil was kinked at one location and was also punctured at a separate location. Although, not conclusive, it appears this observed punctures are the result of the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Since the electrodes were not returned as well a full evaluation of the entire lead could be performed so a failure in that section of the lead could not be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7081841
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« Reply #646 on: June 21, 2019, 01:01:26 AM »

Model Number MODEL 3000
Device Problems Energy Output To Patient Tissue Incorrect; Improper Device Output
Event Date 11/10/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that this patient was programmed to 0. 25ma using the m3000 software. When system diagnostics were run with the m3000 software, they were run at 1. 0ma which caused the patient pain in the neck area. The patient was re-interrogated and found to still be at 0. 25ma and diagnostics were run again, and this time, were correctly run at 0. 25ma with the m3000 software. Next the patient was programmed to 0. 375ma and diagnostics were run using m250 software, which were performed correctly at 0. 375ma. These events have been determined to be due to software error in the m3000 programmer that causes certain parameters to be incorrectly calculated in m106 generators. These incorrect calculations along with a combination of programmed settings, magnet swipes, and autostimulation may lead to a period of continuous current ramping for part or all of an entire therapy burst. During this ramping, the current can exceed programmed values. This is likely the cause of the patient's reported painful stimulation. To resolve this issue, the patient's settings were reprogrammed to avoid this problem. No further relevant information has been received to date.
 
Manufacturer Narrative
Software version 1. 0. Serial #, corrected data: initial report inadvertently did not list a serial number. Unique identifier #, corrected data: initial report inadvertently did not list a di number.
 
Event Description
During a database review, it was observed that during the initial interrogation the generator was found to be in a pulse disabled state due to burst watchdog timeout (bwt). The combination of normal mode and magnet mode output current for this generator resulted in an excessive magnet ramp time that would result in bwt after a magnet stimulation. After the first interrogation, diagnostics were attempted but were faulted and logs show that no data was received back from the generator. However, as this occurred prior to therapy being programmed back on, the attempted diagnostic would have used a 1ma burst by design. After the output current was programmed back on and set to a specific output current, an additional diagnostic test was performed, and the achieved output current was as expected. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7088895
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« Reply #647 on: June 21, 2019, 01:02:13 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/19/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported originally that the patient was having throat discomfort after his last replacement which he believed to be due to vns stimulation. Later on (b)(6) 2017 the patient was experiencing vocal cord paralysis and was having difficulty managing his airway after consulting an ent. With the magnet in place, the ent could see some movement in the left vocal cord only and the patient was better able to maintain his airway. With the magnet removed and vns back on, the vocal cord stopped moving and his oxygen saturations declined. The device was programmed off. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Later information from the physician provided on 10/25/2017 that the patient was experiencing urine retention, lethargy, difficulty eating and drinking, and needed oxygen support. He had been taken to the hospital for difficulty breathing and maintaining oxygen levels. On (b)(6) 2017 a lot of swelling was found in the throat and was admitted to the hospital a day later. On (b)(6) 2017 the patient was taken to the icu and was put on a ventilator and the airway was almost completely swollen shut. On (b)(6) 2017 the vocal cord paralysis was identified and showed improvement after using the magnet to disable vns. On (b)(6) 2017 movement was seen in both the left and right vocal cord although still partially paralyzed, the patient's stats were normalizing well. The device was turned off at that time. On (b)(6) 2017 follow-up with an ent showed a lot of movement was seen in vocal cord but still had partial paralysis. It was reported that the seizure frequency has actually decreased since turning off the vns device. Diagnostics performed by the company representative on (b)(6) 2017 were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7099705
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« Reply #648 on: June 22, 2019, 03:53:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/31/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A vns patient stated that the left side of her neck hurts every time the vns turns on and that it puts her into a ¿seizure mode¿. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the provider indicated that the vns is not causing an increase in seizures or causing the patient to go into ¿seizure mode¿. The increase in seizures is not worse than before vns. It was reported by the patient that the device was turned off, intended to be temporary due to the pain in the neck.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7194739
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« Reply #649 on: June 23, 2019, 04:28:46 AM »

Model Number 304-20
Device Problem Fracture
Event Date 12/09/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by caregiver that a vns patient was experiencing chest pain, stomach ache, and neck pain since (b)(6) 2017. She thinks these events are related to vns stimulation. She also stated that there is a "line" tracing the lead wire, and she states that she can feel the end of the lead wire in his neck, and it feels pointy, as if it is broken. Follow-up to the treating provider indicated that upon palpation the lead device felt broken in the neck area. The device was palpable near the center of the neck, due to the break in the lead. It was stated that it was also observed to be broken upon review of x-rays taken. The patient was referred for surgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7159297
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« Reply #650 on: June 23, 2019, 04:29:25 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/09/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was referred for vns replacement due to the desire for a newer model of vns generator and the patient was complaining of feeling a shock when he lays on his left side. The clinic notes received indicated that the patient turned over while laying down and felt a shock all through the chest. It was stated that most of the time when the patient was laying down on his left side at night, it hurt. It was noted that the patient's care facility staff would not use the vns magnet anymore due to the physician stating it was dangerous. It was stated that the patient reported that his neck and chest hurt a couple times a day. The patient's neck hurts when flexed or extended and when the vns stimulates. It was later reported that the patient's replacement surgery was put on hold due to the patient having a brain mass that was unrelated to the vns. No additional relevant information has been received to date.
 
Event Description
Follow up with the physician's office revealed that there were no issues with the vns. Chest x-rays were performed to assess the reported pain and a mass was found in the patient's chest. It was stated that it was cancer and that the patient's vns would remain implanted as the cancer was more of a priority. The physician stated that she believed that the reported pain was a result of the mass and was not related to the vns.
 
Event Description
It was reported via clinic notes received that the patient was experiencing intermittent pain for approximately a week. The patient believed it happened only with certain position changes, such as when laying in bed at night and rolling onto his left side or sitting in a chair and reaching across his body to pick something up off of the floor. It presented as a pain in the patient's left chest and was described as a "shock burn" all through the chest, lasting between a few seconds up to a minute. No pain in the neck was reported. The patient recalled previously reported a similar event the previous year, which was previously reported in this mfg. Report. Follow up with the physician revealed that the pain was a continuation of the pain previously reported due to the cancerous mass. No further reports will be made regarding the pain due to the cancerous mass, which was not related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7172237
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« Reply #651 on: June 23, 2019, 04:30:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/21/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes from a visit on (b)(6) 2017 were received indicating that a vns patient¿s device is skipping. The patient reports that he does not feel good, and the vns is giving him erratic stimulation. He reports pain with stimulation, and reports the vns is making him sick. The device was turned down which helped, but did not stop it. It was reported the device was malfunctioning and referral was made for replacement. On a visit dated (b)(6) 2017 it was reported the vns was giving him abnormal impulses. He reported the vns was checked with the wrong device and since it has been giving him abnormal shocks. The diagnostics were reported to be okay. Additional relevant information has not been received to-date.
 
Event Description
Generator revision surgery occurred (b)(6) 2018. The explant facility does not return products to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7159246
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« Reply #652 on: June 25, 2019, 01:50:42 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/23/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinical notes were received indicating the patient was feeling pain in her chest around the vns implant and painful stimulation in her left chest. The neurologist's notes stated the generator battery is likely at its end of life but no battery indicator was noted. The notes also stated the device's impedance value was normal when accessing the vns system, but no impedance value was provided. The patient was referred for generator replacement due to these events. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.
 
Event Description
A fax was received from the patient's neurologist that indicated the replacement was related to the painful stimulation and provided recent system diagnostics. Both the generator and lead were subsequently replaced. Both devices have been received. Analysis is underway but has not been completed to date. No additional or relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis for the returned generator and lead has been completed and approved. The generator's output signal was monitored for more than 24-hrs with the generator placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and that the device provided the expected level of output current for the entire monitoring period. There was no indication that an end of service condition existed. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The lead was returned in two portions. Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7304009
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« Reply #653 on: June 25, 2019, 01:51:30 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 01/31/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A nurse practitioner reported to a company representative that she observed an impedance value around 7000 ohms on the patient's device, indicative of high impedance. Since the patient was receiving good seizure control with vns, the nurse wanted to keep stimulation enabled, so the vns output current was programmed to 1ma for the patient's device; however, shortly after the settings adjustment, the patient experienced painful stimulation in her neck. Stimulation was reduced to 0. 75ma, and the patient was referred for surgery. X-ray images were provided to the manufacturer for review, but due to the quality of the images, a cause of the high impedance could not be determined. Proper pin insertion or integrity of the lead body could not be evaluated with the provided images. The patient underwent lead and generator replacement surgery due to the high impedance. The surgeon did not visually observe any problems with the lead or with the insertion of the lead pin into the generator. The existing generator was explanted and replaced with a new generator, and high impedance was observed multiple times on the system. The surgeon verified that the lead pin of the existing lead had been fully inserted into the new generator. The existing lead was then replaced with a new lead, and diagnostics were within the normal limits. The explanted lead and generator have not been received by the manufacturer for analysis to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The explanted lead and generator were received by the manufacturer for analysis. Analysis approved for the generator. When received, the data was downloaded from the generator and reviewed. High impedance values were observed in the data. The generator was interrogated, and system diagnostics were performed and returned results within the normal limits. The generator was able to deliver the output current as programmed over a 24-hr monitoring period. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator. Analysis was approved for the lead. The lead was returned in multiple pieces. Note that since the electrode portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Microscopy images of the negative coil show that pitting occurred at the break location. The microscopy images also suggested that a stress-induced fracture occurred in at least three strands of the coil. Abraded openings were noted on the outer and the inner silicone tubing, and dried remnants of body fluid were observed inside the tubing at these opening locations. A lead break was identified in the negative coil. The observed abraded openings on the outer and the inner silicone tubing may possibly have contributed to the painful stimulation the patient experienced. No other anomalies were identified in the returned lead portions. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7293996
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« Reply #654 on: June 25, 2019, 01:52:17 AM »

Model Number 304-20
Device Problems Mechanical Problem; Low impedance
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that low impedance was detected on the patient's generator on (b)(6) 2018. The patient's lead impedance had been demonstrating a gradual, sustained decrease over time since approximately 2013. The patient had no trauma or falls expected to have contributed to this event. At the time of the detection of low impedance, he patient reported that she sometimes felt painful stimulation in the chest area. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent lead and generator replacement due to low impedance. The suspect product was received but product analysis on the device has not been completed to date. No further relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
Product analysis was completed on the returned lead. There were no conditions observed in the returned portions of lead that could potentially contribute to the reported low impedance. Note that because a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Multiple abraded openings were noted in the outer tubing. The condition of the returned lead portions was consistent with those that typically exist following an explant procedure. No obvious anomalies were noted. Product analysis was completed on the returned generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The device was monitored for 24 hours in a simulated body temperature environment. The generator provided the expected output signal the entirety of the monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7304315
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« Reply #655 on: June 26, 2019, 07:33:48 AM »

Model Number 103
Event Date 05/18/2015
Event Type  Injury   
Event Description
It was reported that the patient presented on (b)(6) 2015 as an emergency to adjust his vns output current. For three weeks, he had experienced constrictive larynx and was unable to breathe in the morning, per the physician. The output current was decreased from 0. 75ma to 0. 25ma. Additional information was received that the patient was experiencing pain in the throat and jaw with stimulation. The plan was to obtain x-rays of the leads and to discuss the symptoms with the surgeon. Lead impedance was okay with impedance around 3700 ohms. Good faith attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4886749
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« Reply #656 on: July 01, 2019, 10:42:36 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/15/2018
Event Type  Malfunction   
Manufacturer Narrative
Event Description
A patient had reported been experiencing a minor, sharp stabbing sensation with stimulation for approximately 1 month. Per the patient, the pain was tolerable. Both system and normal mode diagnostics were performed, and high lead impedance was observed for the patient's device. The patient was referred for surgery to resolve the high impedance, but no surgical intervention has 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=7503210
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« Reply #657 on: July 05, 2019, 10:49:20 PM »

Model Number 304-20
Device Problem High impedance
Event Date 05/24/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A report was received that a patient was complaining about painful stimulation in their neck, jaw, and teeth. Diagnostics revealed the patient's device had high impedance. The patient's device has been programmed off. The patient has not be referred for x-rays or replacement. Device history records were reviewed for the generator and lead, and both passed all functional specifications and quality tests and were sterilized prior to distribution. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8708030
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« Reply #658 on: July 05, 2019, 10:49:57 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was involved in a motor vehicle accident and following the accident began to experience painful stimulation in his jaw which prevented him from sleeping comfortably. The patient was given pain medication that did not resolve the pain. The patient reported the pain to be unbearable and went to the emergency room where the generator settings were not adjusted due to the risk of increases seizures. The patient's neurologist performed x-rays of the device and reported that the x-rays appeared normal and the diagnostics were within normal limits. The patient underwent generator replacement due to the adverse events that followed from the car accident and due to their jaw tingling. The neurologist indicated that the diagnostics were within normal limits. The suspect product has not been received to date. Multiple attempts were made to obtain additional information however, further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8678559
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« Reply #659 on: July 05, 2019, 10:51:12 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was underwent vns generator replacement surgery. The replacement reason provided was prophylactic on the implant and warranty registration form received. It was also reported that the patient fell on her chest in january and, since the fall, could feel the generator moving and experienced painful stimulation with every stimulation. A review of device history record revealed that the generator passed quality control inspection prior to distribution. Follow up with the surgeon's office revealed that the surgeon stated that a suture had to be removed intraoperatively and, therefore, the device was not able to move in the patient's chest. During attempts at product return, it was revealed that the explanting facility does not return explanted products without a signed form. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8717155
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