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dennis100
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« Reply #210 on: January 05, 2019, 02:26:42 AM »

Model Number 106
Event Date 11/25/2018
Event Type  Injury   
Event Description
On sunday (b)(6) 2018, the vns device implanted in pt (b)(6) began discharging at a near-constant rate. The frequency of the device's activity became intolerance to (b)(6). On several occasions, throughout sunday, (b)(6) and monday, (b)(6), (b)(6) attempted to deactivate the device using the accompanying magnet and procedure provided. At times she had assistance from two different trusted individuals who ensured that the procedure was being followed as described in provided instructions. However, at no time would the vns device deactivate as a result of following said procedure. On monday, (b)(6), (b)(6) telephoned the office of her neurologist, dr (b)(6) , who was out for the day. The nurse on staff recommended that the device be taped to (b)(6) chest and that this would result in deactivated. (b)(6) did as instructed but, again, the device did not deactivate as promised. On tuesday, (b)(6), (b)(6) visited (b)(6) who deactivated device using the technology available to her. As of now, (b)(6) has left device in an inactive state, due to concerns about being unable to deactivate it at will, as had been promised prior to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8146915
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dennis100
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« Reply #211 on: January 14, 2019, 04:11:52 AM »

Model Number 102
Event Date 05/02/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was shocking the patient on (b)(6) 2014. The patient¿s device was tested on (b)(4) 2014 and diagnostic results revealed high lead impedance. The patient¿s device was subsequently programmed off. No patient trauma had occurred. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The patient was last seen on (b)(6) 2014 and there was no evidence of a device malfunction at that time; the patient's device settings were reported to be stable. The notes indicate that the patient¿s device was providing stimulation on an irregular basis and was dysfunctional but did not cause any seizures. The shocking from the device caused coughing and pain. The patient went to the emergency room on 05/02/2014. The magnet was taped over the patient¿s device. The patient felt one pulse of stimulation and the device reportedly stopped responding. The patient did not have any seizures while in the er but did have 2-3 auras. During the office visit, the physician noted a little lateral gaze nystagmus and the patient¿s device showed high impedance. With the magnet removed, the patient jumped whenever his device delivered stimulation which caused coughing and pain. The magnet was taped back over the device and the patient¿s medication was increased. X-rays were provided to the manufacturer for review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The complete lead connector pin insertion could not be assessed due to the poor quality of the images provided. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Incomplete lead pin insertion could be a possible cause of the high impedance. However, no definitive conclusions can be made with the images provided. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has not been returned to date. Review of the available programming and diagnostic history showed normal diagnostic results through 12/28/2010.
 
Event Description
Further information was received that the physician recalled that the patient also had continuous stimulation during the time the vns had high impedance. No further relevant information has been received to date.
 
Event Description
An implant card was received indicating that diagnostic results with the replacement generator and existing lead showed lead impedance within normal limits (impedance value ¿ 2644 ohms).
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838963
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dennis100
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« Reply #212 on: January 20, 2019, 03:32:22 AM »

Model Number 103
Event Date 04/22/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.
 
Event Description
Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.
 
Event Description
It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. 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. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.
 
Event Description
It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.
 
Event Description
Additional information was received that the patient's generator could never get regulated correctly. It is suspected that the regulation of the device refers to titration. Available programming history for the generator was reviewed. The patient's device was disabled the day of explant. Diagnostics at that time were within normal limits. After implant of the device, it was titrated to 0. 25 ma and the output current was increased up to 1. 5 ma a few months later. However, the settings were reduced down and disabled shortly after.
 
Manufacturer Narrative
Only the generator was replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253
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dennis100
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« Reply #213 on: March 03, 2019, 04:52:33 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/15/2015
Event Type  Malfunction   
Event Description
The explanted lead and generator were received on (b)(4) 2015. Analysis of the generator was completed on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the explanted lead was completed on (b)(4) 2015. The reported allegation of "abraded insulation" was verified. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were found.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for exploratory surgery due to an increased perception of stimulation which was described as painful and erratic. The patient's device was tested and showed normal device function. The patient's device was temporarily disabled using the magnet and the painful stimulation resolved. The physician decreased the programmed device settings and the patient tolerated the adjustment well. It was noted that painful stimulation issues began after the patient experienced a drop seizure. The patient underwent exploratory surgery on (b)(6) 2015. The lead was found to have an abraded opening in the silicone tubing and was replaced. The generator was replaced prophylactically. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4922779
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dennis100
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« Reply #214 on: March 05, 2019, 06:47:40 AM »

Model Number 304-20
Device Problem High impedance
Event Date 08/20/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient has high impedance that was first observed on (b)(6) 2015. The patient was also feeling erratic stimulation recently that appears to be associated to the high impedance. There was no recent trauma for the patient. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2015 it was reported that the patient underwent a full revision that day. The generator and lead were discarded and therefore could not be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024896
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dennis100
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« Reply #215 on: March 19, 2019, 01:25:30 AM »

Model Number 300-20
Device Problem Appropriate Term/Code Not Available
Event Date 04/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient was feeling of sporadic and painful stimulation. It was reported that patient seizures are well controlled and patient has been seen a huge improvement with the vns therapy. It was reported that patient underwent generator replacement for prophylactic reason (b)(6) 2015 and the adverse events persist. The explanted generator was reported as disposed of by the hospital and will not be returned to the manufacturer. Further information was received that the intense stimulation continues with the new generator. It was also reported that patient had increase in seizures; the current seizure rate is above pre-vns levels. It was reported that the medical professional suspects a problem with the lead such as current leakage which may not appear on the diagnostic test, therefore evoked potential test in various positions will be performed. It was reported that regardless of outcome evoked potential outcome, lead revision is expected. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Age at time of event and date of birth; corrected data: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth.
 
Event Description
Further information was received from the physician, indicating that a new diagnostic test was performed and returned impedance results within normal limits with 1344 ohms. An emg-based lead test was also performed which resulted to be normal. It was reported by the physician that, despite these results, they decided to replace both the lead and the generator (since the lead is 18 year old). No known surgical intervention has occur to date.
 
Event Description
An implant card received by the manufacturer and the review indicates that the vns patient underwent full revision surgery on (b)(6) 2016 and that the re-implant was due to lead break. The lead impedance for the new implant was marked as ok - 1486 ohms. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
A return good authorization number request was received by the manufacturer to return the explanted generator model 104 serial number (b)(4) implanted with the suspect device involved in the present case. Return of the generator for analysis is expected, but it has not been received to date.
 
Event Description
Portion of the suspect lead was received by the manufacturer. The explanted generator was received as well. It was reported that the reason for replacement is patient experiencing stimulation more than expected: side effect of a leak of electricity. Analysis of the suspect lead was completed and the allegations were not verified within the returned lead portions. Since a significant 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 anomalies were identified in the returned lead portions. Review of manufacturing records confirmed all tests passed for the lead prior to distribution.
 
Event Description
Analysis was completed on the explanted generator and reported allegation of "high impedance" was not duplicated. Review of the data downloaded from the generator shows a possible indication of increased impedance from a value of 1305 ohms, to a value of 22812 ohms, and the time of change detection was (b)(6) 2016 (generator explant on (b)(6) 2016). The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2015 with an impedance value of 1357 ohms (implant (b)(6) 2015 / explant (b)(6) 2016). Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, the battery status was ifi no. The data in the "diagaccumconsumed" memory locations revealed that 16. 488% of the battery had been consumed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5229194
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dennis100
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« Reply #216 on: April 15, 2019, 01:21:27 AM »

Model Number 302-30
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
It was reported that in (b)(6) 2016 the patient reported erratic stimulation. It was reported that in (b)(6) 2016 the patient reported that he had fullness in his head, continuous stimulation for 2 hours, voice hoarseness, and painful stimulation. The patient reported that it started when he turned his head a certain way, and demonstrated it to the physician. Due to these symptoms, the patient's device was disabled in (b)(6) and the patient was referred for generator replacement surgery. After disablement, the patient continued to report feeling intermittent stimulation, pressure in his head, and painful stimulation. The patient reported that when he turns his head, he can feel his voice change and stimulation, despite the fact that the output currents were off. The painful stimulation was reported as occurring in the neck and the head. Impedance was reported to be normal at 1171 ohms. A review of ap chest x-rays identified a potential lead fracture located on the upper left side of the generator. The treating physician also believed that there was a lead fracture. There was no known trauma or manipulation at the site of the fracture. The patient has had anxiety in the past, and this was indicated by the physician as a possible reason for the patient's symptoms post-generator disablement. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
Further programming/diagnostic history from the physician's tablet was reviewed. All reported impedance values were within normal limits. Internal data was reviewed and found that, given the small values of impedance, the changes in impedance detected could be normal. No additional relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980471
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dennis100
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« Reply #217 on: April 17, 2019, 07:04:31 AM »

Model Number 106
Event Date 08/17/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a vns patient was having an increase in seizures and his medications are being increased as a result. His vns was increased to 1. 75ma. It was later reported on (b)(6) 2016 that the patient stated feels that his vns is going off every few minutes due to the auto-stimulation. Follow-up from the patient provided that it was decided to turn off the autostimulation and hr detection and see how it does. The vns was also turned down to the original setting of 1. 25ma. A call was received from the patient on (b)(6) 2016 reporting he is still having increased seizures. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the company representative who attended the patient's next clinic visit provided that the patient was not able to feel stimulation unless he pushed on the electrodes. The patient's seizures had increased. Lead impedance after diagnostics were within normal limits. Three more diagnostics were performed with the patient's head in different positions. In the positions turned to the right and to the center the impedance was within normal limits, but with the head turned to the right high impedance was found. X-rays were taken and reportedly didn't show any issues. The patient was scheduled for revision surgery on (b)(6) 2016. During the surgery, the surgeon identified that the lead pin had not been tightened. The pin was inserted, but the set screw was loose. After the lead pin was tightened, the 106 generator was interrogated, and the high impedance resolved. The battery showed the generator was at near end of service. The patient had been feeling erratic stimulation at his electrode site since (b)(6) 2016, and they believed it was due to the incomplete pin insertion. The old 106 was explanted because due to the low battery. The generator was replaced and diagnostics were performed in multiple positions to ensure that there was not an intermittent lead issue. The impedance was good throughout the diagnostics. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted device was received 11/08/2016. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed for the returned generator. No obstructions were observed in the pulse generator header lead cavity or the connector blocks. The pulse generator header lead cavity was tested and was within specification requirements. Review of the downloaded data shows high impedance on (b)(6) 2016 with an impedance value of 5,475 ohms. The results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified. The device output signal was monitored while the pulse generator was placed in a simulated body temperature environment and showed no signs of variation in the output signal demonstrating the expected level of output current. Electrical evaluation showed that the pulse generator performed according to functional specifications. The downloaded data showed 4. 498% of the battery had been consumed with a voltage of 3. 294 volts.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5950882
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dennis100
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« Reply #218 on: April 29, 2019, 05:47:08 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/22/2016
Event Type  Injury   
Event Description
A report was received which indicated that the patient's generator was not working. Clinic notes were received which indicate that the patient reported that the vns was firing inappropriately causing her discomfort. The patient's device was then disabled and the patient indicated that they wanted the device removed. On (b)(6) 2016 the patient's device was disabled and the patient was referred for removal surgery, which has not occurred to date. Follow up with the neurologist's office indicated that the patient had experienced a burning sensation in her chest and throat and had pressure in her neck as well. No diagnostic information was available for the patient's device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6230392
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dennis100
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« Reply #219 on: May 09, 2019, 07:19:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2016
Event Type  Injury   
Event Description
It was reported by the patient that he had been ¿going out¿ and that he wasn¿t sure if the vns was causing it. He said that he could also just be falling asleep, it could be a seizure or it could be his medication, but he was concerned that the vns and/or the vns and his pacemaker could be causing it. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: the following information was inadvertently not reported on the initial mdr "it was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. " event problem cds, corrected data: the patient codes were inadvertently not included in the initial mdr (b)(4).
 
Event Description
It was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. The patient reported his device was being explanted because it wasn't working because he could now feel stimulation. The patient also indicated that he had a pacemaker for atrial fibrillation. The patient then called and said that his painful stimulation was definitely occurring more often than what he expected it to and that he wanted the company representative to come disable it. The patient then reported to the company representative that nobody had programmed off the device or interrogated it since the last, but that he had talked to his primary care physician and the painful stimulation had resolved. No further relevant information has been received to date. No related surgical intervention has occurred to date.
 
Event Description
It was reported by the physician's office that the patient did not have a good memory. It was also indicated that sometimes he "sometimes just needed to speak to someone to calm him down" after his call to the manufacturer was described. 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=6503540
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dennis100
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« Reply #220 on: May 10, 2019, 01:42:03 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2003
Event Type  Injury   
Event Description
Clinic notes were received for vns removal. The notes indicated that vns will be removed as it has been off for over 5 years. The patient has been undergoing chemotherapy for throat cancer. The patient reported that the vns is bothersome as he feels it in his throat as if it is on. The device according to the patient was turned off 4 years ago for lack of efficacy. The device was interrogated during this appointment and confirmed to be off. Battery was stated to show ifi-yes (although model 101 so likely neos). Notes indicate that the patient reports erratic sensation of vns stimulation in the throat. He has seen gastroenterology who performed endoscopy and reported abnormalities in the throat. The patient does not believe the report and suspects it¿s the vns and is adamant that he wants referral for removal. The abnormalities in the throat are still be looked into. No surgical intervention has occurred to date and no additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8508514
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dennis100
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« Reply #221 on: May 11, 2019, 01:40:01 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2019
Event Type  Injury   
Event Description
It was reported in clinic notes that the patient feels the vns has been fluttering recently, and that the stimulus was not as strong as it could be. The battery life was given as 50% at their appointment. A battery life calculation was performed on the programming history. The patient¿s device would be expected to provide 9. 9 years to near end of service. No anomalies were seen. The neurologist believes that the patient¿s device fluttering may be due to a possible device malfunction; however the diagnostics from the day of the appointment show the device is functioning as intended. 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=8484251
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« Reply #222 on: May 11, 2019, 01:40:43 AM »

Model Number 1000
Device Problem Insufficient Information
Event Date 03/19/2019
Event Type  Malfunction   
Event Description
It was reported by the patient's mother that the patient felt something "funny" was going on with their generator stimulation, that it was stimulating erratically. The patient's mother reported that the neurologist received an error code while titrating the patient's generator. No clarification has been received regarding the error code that was seen by the physician to date. Multiple attempts to obtain additional information regarding the error code have been made; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8502099
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« Reply #223 on: May 30, 2019, 06:14:07 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 05/17/2017
Event Type  Malfunction   
Event Description
It was reported that the patient had high lead impedance and erratic stimulation. It was later reported that the patient was being shocked and the shock felt more intense. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
The patient underwent surgery to replace their generator prophylactically and their lead due to high impedance. No further relevant information has been received to date. The suspect product has not been returned to date.
 
Event Description
The explanted generator and lead were received. Product analysis on the devices has not been completed to date. No further relevant information has been received to date.
 
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. Product analysis was completed on the returned lead. The lead body was returned in two pieces. The electrodes were not returned and so could not be evaluated. Product analysis verified the presence of a lead fracture in two places. At these two locations, there were abraded openings in the inner and outer tubing. Scanning electron microscopy showed pitting occurred at the break locations. Due to the pitting, the fracture method could not be determined. No other anomalies were identified in the returned lead portions. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6633172
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« Reply #224 on: June 08, 2019, 06:01:45 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/24/2019
Event Type  Injury   
Event Description
The patient reported that their generator is ¿going on and off. ¿ the patient was seen by their neurologist regarding this report of erratic stimulation, and the neurologist believed that the device was ¿malfunctioning. ¿ the neurologist mentioned that the patient all of sudden was having an increase in seizures after being seizure free. The physician additionally reported that it was observer that generator was set at 1% duty cycle; however, the physician denies purposefully setting the duty cycle to 1%. A system diagnostics test was performed at the patient¿s appointment and confirmed that the device was functioning properly. The doctor turned off the generator, as the patient stated it was bothering her and referred the patient to the neurosurgeon for battery replacement. An implant card was received confirming that the patient's generator was explanted and replaced due to battery depletion and "irregular stimulation". An image of the parameters and system diagnostics test from the patient¿s appointment was later received. Reviewing the patient¿s parameters it was noticed that the patient was programmed to a 29% duty cycle; however, the programmer falsely displayed a 1% duty cycle. There is a known display error that would explain why a 1% would show after system diagnostics. Any time system diagnostics is performed in-session and the user navigates back to the parameters screen, all values will display correctly (including on time and off time), except for the calculated duty cycle, which will show 1%. This display occurs because the system diagnostics will program the generator to this duty cycle to run diagnostics prior to programming them back to the intended cycle. In these cases the generator is operating at intended duty cycles settings and re-interrogation will resolve the display error. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8623571
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dennis100
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« Reply #225 on: June 10, 2019, 12:56:42 AM »

Model Number 103
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 11/01/2013
Event Type  Malfunction   
Event Description
Report received that a patient's device malfunctioned and stimulated whenever it felt like. The generator was reportedly turned off. A few years later it was turned back on and reportedly caused the patient to lose her breath. The generator was turned back off. Because of this, the generator was reportedly explanted. The available date from the programming history indicated the device had worked as intended, but the reported events occurred after the last day of available data. A review of the device history record indicated it had passed all quality inspections and electrical tests prior to release for distribution. The patient refused to provide the physician's name and the physician could not be found. The patient's former physician was contacted, but she did not know who the patient currently saw. Therefore, further follow-up could not be completed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6980871
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dennis100
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« Reply #226 on: June 12, 2019, 02:44:02 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 #227 on: June 14, 2019, 06:13:35 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Event Description
Patient again complained that the device had moved down all the way to the middle of her breast tissue. The device moves all around and patient reported experiencing sporadic stimulation. Patient did not want the device off. Diagnostics was performed and lead impedance was in range. Patient underwent explant of the generator. The surgeon mentioned that the device did not migrate and that the patient wanted the device out while she is breastfeeding. Patient recently had a baby and is concerned that the stimulator will go off while she is breast-feeding. The patient was recommended to have the device disabled during the breastfeeding. Patient said that she continues to have what she calls "shocks "even after the device was turned off and requested explant. Patient underwent explant of the generator. The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7045098
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dennis100
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« Reply #228 on: June 15, 2019, 11:23:54 PM »

Model Number 102R
Device Problem Detachment Of Device Component
Event Date 10/23/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was having difficulty with his vns causing pain and some erratic readings. The neurologist notified the surgeon and they wanted him to be seen urgently and possibly have surgery. The patient¿s generator was explanted. Further information was provided that the explanted generator appeared to be ¿split in two. ¿ from images provided it appears that the header on the generator was detached. It was also stated that the patient had felt infrequent stimulation. Impedance prior to surgery was stated to be within normal limits. Regarding the initial report of pain, it was stated that the pain was infrequent, and felt as if he could hardly feel stimulation and all of sudden felt higher stimulation. The pain was felt at the left chest just under the clavicle. The ¿erratic readings¿ report was referring to the patient¿s infrequent stimulation. The 4000-5000 ohms impedance was verified to be from system diagnostics. The physician believes that the detachment of the header occurred prior to surgery, most likely believed to be due to day to day activity as the patient has lived a ¿hard¿ life. The explant generator has not been received for analysis to date. No additional relevant information has been received.
 
Event Description
The generator was received for analysis. Product analysis is currently underway but has not been completed to date.
 
Manufacturer Narrative

Event Description
Product analysis for the generator was completed and approved. The reported ¿detachment of header¿ allegation, was confirmed in the lab. A window was cut into the can and test leads were attached to the output connections for monitoring of the device and for testing purposes. The device output signal was monitored for more than 24-hrs, while the 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. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications of the current automated final test. Other than the header anomaly, there was no abnormal performance or any other type of adverse condition found with the generator. The cause of the header detachment could not be determined in analysis. Examination did not reveal body fluid remnants on the can, which would indicate partial separation during the implant period.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7039508
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dennis100
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« Reply #229 on: August 10, 2019, 12:43:40 AM »

Model Number 105
Device Problem Energy Output Problem
Event Date 08/01/2018
Event Type  Malfunction   
Event Description
Patient reported that the device was disabled. The reason for disablement was noted to be due to the device malfunctioning by the patient. The patient noted that the device would turn on and off and up in the past on its own. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8793108
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