VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on June 10, 2014, 07:13:04 PM



Title: Arms
Post by: dennis100 on June 10, 2014, 07:13:04 PM
Event Date 02/01/2001
Event Type  Injury   
Patient Outcome  Disability; 
Event Description 
Reporter indicated that patient has no movement in left arm. 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=326677


Title: Re: Arms
Post by: dennis100 on June 10, 2014, 07:14:36 PM
Model Number 103
Event Date 01/24/2014
Event Type Injury
Event Description
The vns physician reported that the patient had not been seen for about three years. The physician's office has not received any further reports of pain from the patient, and to their knowledge, the implanted vns system was working properly at the time of the reports of pain. Information obtained indicates that the explanted devices were sent to the hospital's pathology department after surgery and subsequently discarded.

Event Description
It was reported that the patient was scheduled for exploratory surgery and possible generator replacement. It was reported that the patient experienced pain (9/10) at the generator site which the patient was seen at the emergency room for. The physician reported that the pain has been occurring for approximately three months and the pain goes from the generator to the patient's shoulder down into the patient's arm which the physician reported is not a normal radicular pattern. It was reported that cardiac issues and pulmonary embolism were ruled out. A ct scan of the chest did not identify any abnormal fluid collections around the generator. It was reported that the patient underwent exploratory surgery with generator replacement due to ifi - yes on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3718781


Title: Re: Arms
Post by: dennis100 on November 07, 2014, 01:30:17 AM
Model Number 103
Event Date 07/28/2014
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient had been experiencing an increase in seizures for the past three weeks prior to his office visit on (b)(6) 2014. The patient also began having several generalized tonic-clonic seizures which have not been observed while the patient has had vns. Following vns, the patient has had three primary seizure types: (1) tonic movements of the arms with head deviation to the left, (2) chewing automatisms with head bobbing of the head and neck, and (3) facial grimacing. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Review of the available programming and diagnostic history.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4184637


Title: Re: Arms
Post by: dennis100 on February 06, 2015, 07:25:43 AM
Model Number 103
Event Date 12/01/2014
Event Type Injury
Event Description
The patient underwent a battery replacement on (b)(6) 2015. The device has not been received for analysis to date.

Manufacturer Narrative

Event Description
The patient's m103 device was returned for analysis on 02/12/2015. Product analysis of the generator was completed and approved on (b)(6) 2015. In the pa lab, 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a neos=yes condition. The electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the near-end-of-service (neos) condition is an expected event.

Event Description
It was reported that the vns patient was experiencing pain and arm jerking with stimulation on-times. The patient had also been having some increased seizure activity. The patient¿s device was tested and showed an end of service condition. It was noted that patient harms himself and that there was scarring at the neck. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377344


Title: Re: Arms
Post by: dennis100 on October 06, 2015, 12:17:50 AM
Model Number 102
Event Date 11/22/2010
Event Type Injury
Event Description
On (b)(6) 2013, the nurse from physician's office called back about the patient. She stated that the patient is still in pain. The patient was tested for infections, musculersclerosis, "everything", but everything turned out negative. It was reported that it was possible it could be pain syndrome, but the cause of the pain is unknown. On (b)(6) the patient's device was turned off; however, the patient was still experiencing pain. It was concluded that the pain was not associated with stimulation on times and the nurse stated that they could not see any relationship between the pain and vns. It was also reported that the patient had shortness of breath related to the vagus nerve. Physical therapy was suggested to the patient for thoracic syndrome and the nurse stated that they would be following up with that. The patient also has anxiety issues, which was a possible contributing factor, per the nurse. In regards to the allergy, the patient was given benadryl and referred to the primary care physician. There was no verification from physician's office that anything was done. The nurse clarified that the parent reported there was an allergic reaction, but there was no documentation to support that there ever was such a reaction. The only information the physician has on the allergy was the parent's report. The patient is experiencing pain in the knees, chest, and arms. There have been no medication changes or external factors (from a neurological standpoint) that would have caused or contributed to the event. No direct correlation has been found for the cause of the pain. The nurse stated that at this point everything is speculation. No other information was provided.

Event Description
On (b)(6) 2013 it was reported that the patient had a full revision in 2010 and since then has reported pain in both of her arms and chest/ rib cage area. The physician disabled the patient's vns device for a brief period; however, they could not determine the relationship to vns or if the pain was related to stimulation. It was also reported that the patient had an extreme allergic reaction to the anesthesia during the full revision, but the connection to vns and the reports of pain were unclear. The patient's last known settings were provided and it was noted that ifi = no. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3194207


Title: Re: Arms
Post by: dennis100 on October 09, 2015, 01:31:18 AM
Event Date 09/03/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 the patient had come in the day prior and was complaining of radial arm pain. The vns device was interrogated and system diagnostics were run and everything was fine. It was discussed that the patient had lost over (b)(6) lbs since implantation and the device has moved medially. It is right on her chest bone now. The physician thinks that her arm pain might be due to the device moving and putting pressure on a nerve. He is referring her to a neurosurgeon for a revision of the placement of the generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5112349


Title: Re: Arms
Post by: dennis100 on October 15, 2015, 11:12:08 AM
Model Number 300-20
Event Date 10/04/2012
Event Type Malfunction
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient was seen on (b)(6) 2012 and high impedance was observed on a system diagnostic test. The generator was programmed off and x-rays were ordered. There was no reported trauma to the neck and chest and the patient has been seizure free. The patient was last seen in january and at that time, the diagnostics were said to be within normal limits, however specifics were not provided.

Event Description
Clinic notes dated (b)(6) 2013 were received on (b)(6) 2013. The patient denied any seizures activity since the last clinic visit. The patient's device was programmed off. The notes stated that the patient's device was rechecked several time. There were occasions/positions that the device did not function, lending support to a microfracture. Surgery is likely but has not taken place. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Product analysis was performed on the generator and lead. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the (b)(4) lab, 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 generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. An analysis was performed on the returned lead portions. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 149mm and 93mm portions quadfilar coil 2 appeared to be broken. Scanning electron microscopy was performed and identified the area on one of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The area on the remaining broken quadfilar coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of lead fracture/high impedance.

Manufacturer Narrative

Event Description
On (b)(6) 2013, this patient underwent full revision. Attempts for product return have been unsuccessful.

Event Description
X-ray images were received for the patient and were reviewed. Both connector pins appeared to be fully inserted inside the connector blocks and the feedthru wires appears to be intact. The placement of the generator appears to be normal. A portion of the lead is behind the generator, and cannot be assessed. There appears to be no gross fractures, discontinuities or sharp angles in the portion of the lead that is visible. Based on the x-ray images provided, an exact cause for the report of high impedance could not be determined. A portion of the lead behind the generator could not be assessed, therefore a lead fracture in that portion of the lead cannot be ruled out. The presence of micro-fractures in the lead can also not be ruled out. It was indicated that the patient had done well with vns. The patient has been referred for revision. Surgery is likely but has not occurred to date.

Event Description
The explanted devices were returned on (b)(6) 2013 and are pending product analysis.

Event Description
Additional information was received on the date of surgery, (b)(6) 2013, indicating that the surgeon requested for diagnostics to be performed. Multiple diagnostic tests were performed on the device in the or with the surgeon and some of the results were within normal limits. One system diagnostic test was performed at 1. 0ma which resulted in a dc/dc = 5 and high lead impedance. The patient's output current was then increased to 2. 00ma and the diagnostic test was within normal limits with dc/dc = 3. Normal mode had a dc-dc value of 5 and everything else was within normal limits. Due to this, the surgeon did not think that there was an issue with the lead. The surgeon decided to cancel the surgery as everything seemed to be fine with the lead per the testing that was performed in front of him. The patient's generator was then re-enabled. On (b)(6) 2013 additional information was received indicating that the patient had been experiencing shocking in the arm. It was reported that the patient had been experiencing the shocking pain in the arm since leaving the or. The patient had been seen again by is neurologist and diagnostics again revealed high impedance with a dc/dc = 7. The patient was scheduled for another follow up appointment on (b)(6) 2013. High impedance was again replicated, sitting down and standing up. The neurologist discussed the findings with the surgeon, and the patient is again being scheduled for surgery. The generator was again disabled, and it was indicated that the pain that the patient was experiencing was occurring with stimulation and was believed to be related to the high impedance in the system. Surgery is likely but has not occurred to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that all functional tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2815171


Title: Re: Arms
Post by: dennis100 on November 03, 2015, 09:40:50 AM
Model Number 302-20
Event Date 01/01/2009
Event Type Injury
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the patient was experiencing painful muscle spasms during stimulation in the upper limb. Recent diagnostics performed indicate that diagnostics were within normal limits. The patient was also said to not have had efficacy with the therapy. The site believes that there is a malfunction of the device, and it is expected that the patient will have her system replaced. It was later noted that high impedance was observed, but no diagnostics performed were provided in relation to normal mode diagnostics performed when initially report on patient painful stimulation and muscle spasms. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1513594


Title: Re: Arms
Post by: dennis100 on November 05, 2015, 12:37:02 PM
Model Number 302-20
Event Date 12/19/2008
Event Type Malfunction
Manufacturer Narrative
Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the physician obtained high lead impedance when performing diagnostics on a vns pt's device. The physician requested x-rays and no anomalies were observed. The physician believes that there may be some scarring or there may be a disconnection or break that could not be identified on the x-ray films that is causing the high lead impedance readings. The pt has been referred for surgery to revise the lead as well as have his generator replaced prophylactically at the request of his parents. Follow up with the physician revealed that there was no report of pt trauma or manipulation that could have caused the reported event. The physician did not provide x-rays to manufacturer for review nor did he provide specific diagnostic results. He did state that the pt had also experienced a change in seizure pattern however, he did not know the cause. The pt's previous seizure included left hand and face twitching, but has now changed to upper extremity contractions. The number of seizures has not increased for this pt. The physician adjusted the pt's aed regime as well as his vns programmed settings. Good faith attempts to obtain additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1363931


Title: Re: Arms
Post by: dennis100 on November 15, 2015, 03:08:03 AM
Model Number 302-20
Event Date 01/01/2007
Event Type Injury
Event Description
Reporter indicated a pt was having vns stimulation-related muscle spasms in the left neck, arm, and hand. Parameter changes were attempted to relieve the spasms but were unsuccessful. The patient underwent a right-sided vns system placement. The original vns system was left in the pt and disabled. The patient's symptoms have resolved and the patient is currently receiving right-sided vns stimulation. The original vns system will be utilized if needed in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=875017


Title: Re: Arms
Post by: dennis100 on November 15, 2015, 02:40:03 PM
Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that the 'pt's electrodes were coming off the vagus nerve. " physician notes received by manufacturer indicated that the pt started to "have problems with seizure management" and was experiencing "pain over the left side of face, about the left eye, problems swallowing, problems speaking, and pain with tingling and burning referred into the arms, hands, and now sometimes legs. " "it appears that the lead attached to the left vagal nerve is not well attached and may actually be totally displaced. " the pt was admitted to the hospital, her settings were planned on being changed, and revision surgery planned in an attempt to resolve the pt's issues. Follow-up with the physician indicated that he looked at the pt's x-rays and did not see anything. He also explained that the normal mode diagnostics obtained were ok. Additionally, it was reported that the pt was experiencing headaches and jaw pain. The physician thinks tha it may have something to do with the pt's anatomy that causes the lead to come off. He explained that the pt was extremely psychotic prior to the vns and is now a "completely different person. " revision surgery was performed in 2007. Diagnostics were performed prior to surgery and obtained all normal results with a dcdc code of 3 and eri=no. It was reported that the surgeon found that there was inadequate strain relief "due to improper positioning of the tie downs, the lead was in the shape of a figure 8, and there was a great deal of scar tissue which was never removed from previous surgery that contributed to the pt's events. " the surgeon removed the lead implanted in 2006 and almost all of the scar tissue that was present on the vagus nerve of the pt. There was part of the scar tissue that he did not remove to avoid damage to the vagus nerve. The replacement lead's electrodes were positioned right below the original site of the scar tissue. Diagnostics performed after the surgery obtained normal results.

Manufacturer Narrative
Device malfunction is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861962


Title: Re: Arms
Post by: dennis100 on November 20, 2015, 10:31:44 AM
Model Number 102
Event Date 12/01/2005
Event Type Injury
Event Description
The explanted pulse generator was returned to manufucaturer for analysis. The elective replacement indictor was no, indicating was no, indicating that the pulse generator battyer had not reached end of life. Based on known device settings, the generator battery would not have reached end of life for 0. 88 more years. Use of magnet did stop normal mode stimulation and did initiate magnet mode stimulation and did initiate magnet mode stimulation cycles as intendes. No performance anomalies or any other conditions that may have contributed to the reported events were noted during visual or electrical testing. No instances of erratic stimulation were noted.

Event Description
Further follow-up revealed that the patient also previously reported that the magnet was not always effective in stopping her seizure. The physician reported that device diagnostics resulted in normal and he had changed the generator settings; however, this old eliminate the patient's arm tingling symptoms. The physician also reported that the patient's seizures were above her pre-vns baseline frequency. The physician told the manufacturer that he did not want to provide any further information and would not respond to the written requests due to hipaa. It was further reported that since the patient's fall she had experienced an increase in seizures and intermittent "jolts" in her chest when the devices stimulates. The patient also feels stimulation in her neck. Revision surgery were performed. Only the pulse generator was replaced. The surgeon noted that he observed fluid the lead tubing but the lead testing was ok. It was also reported that since the pulse generator replacement, the patient has had no seizures and is very happy with replacement. The cause of the seizure increase, erratic stimulation, jolts at generator site and left arm tingling are unknown. The cause may have been from an improper lead/generator connection. The manfacturer expects the pulse generator to be returned or analysis.

Event Description
Reporter indicated that vns patient has recently experienced an increase in seizure activity above pre-vns baseline frequency. It was reported that the patient could no longer feel normal mode or magnet mode device stimulation. The patient suffered a fall approximately three months prior, after which she was on crutches. Use of the crutches reportedly caused the patient to experience a tingling in her armpit. The patient's device was programmed to off for approximately three weeks due to the tingling sensation, but was programmed back to on approximately two weeks before the increase in seizure activity began. When the device was first programmed back to on, the patient felt 'mild stimulation' while in the neurologist's office, but no longer feels device stimulation. Device diagnostic testing performed at that office visit was within normal limits, indicating proper device function. It was reported that medications were prescribed to treat the increase in seizure activity. The patient has since changed neurologists. Report is incomplete because no response has been received to manufacturer's requests for additional information from last known neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=660590


Title: Re: Arms
Post by: dennis100 on November 29, 2015, 04:03:10 PM
Model Number 302-20
Event Date 05/22/2009
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient has been experiencing pain from her neck to her hand that began approximately one month following generator and lead replacement six years prior. The pain began with swelling in the patient's neck, shoulder, and arm, and the patient believes that a nerve was pinched at that time. The patient has been on pain medications and has undergone physical therapy and nerve blocks due to the pain. The patient believes that the vns lead electrodes may have been placed incorrectly and that the placement may be putting pressure on another nerve. The patient indicated that the pain occurs with device stimulation because the pain was exacerbated when the device settings were increased in (b)(6) 2014. The patient reported that the device was programmed off for a while and that the pain subsided a great deal. The device was programmed back on in (b)(6) 2015 and the pain began again in (b)(6) 2015. The physician's office reported that the patient has been seen recently and has not reported these events. The physician's office indicated that the patient would be contacted regarding the reported pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4909657


Title: Re: Arms
Post by: dennis100 on December 01, 2015, 05:15:45 AM
Model Number 105
Event Date 02/07/2014
Event Type Injury
Event Description
An article titled "autistic spectrum disorder, epilepsy, and vagus nerve stimulation" was received which included a vns patient who initially experienced improved seizure control following vns implant but was not maintained. At the age of 9, it was observed that the patient was having up to 10 episodes per day of deep inhalation, pupil dilation, truncal flexion, and upper extremity rigidity which lasted up to 30 seconds. Eeg monitoring at that time revealed epileptiform activity arising from the frontal lobes bilaterally. The patient was given lamotrigine which decreased the number of seizures to 3-6 per day. The medication was later increased to the maximum dosage and the seizure activity decreased to once every two days. At the age of 10, the patient began experiencing an increase in seizures with episodes occurring daily and lasting up to 30 seconds. Zonegran was added to the patient's medication regimen which augmented seizure control but with significant side effects. The patient was later weaned off zonegran and implanted with a m105 pulse generator. Prior to implant, the patient was having 1-2 seizures daily. The patient's device settings were titrated up after 5 weeks post-implant, and the patient experienced a decrease in seizure severity and duration (seizures lasting 10 seconds of less). Six months following implant surgery, the seizure frequency increased to 6-10 per day. The patient's device settings continued to be titrated up. At 13 months post-implant, the device settings were increased and the patient's seizure activity decreased to 3-4 per day. Follow-up with the patient¿s following physician revealed that the reason for the increase in seizure frequency was unknown. The patient¿s parents believed vns was not effective in controlling the patient¿s seizures.

Manufacturer Narrative
Hull mm, madhavan d, zaroff cm. Autistic spectrum disorder, epilepsy, and vagus nerve stimulation. Childs nerv syst. 2015 apr 29.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4803280


Title: Re: Arms
Post by: dennis100 on December 04, 2015, 07:45:07 AM
Model Number 304-20
Event Date 10/05/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received that indicated on a recent visit on (b)(6) 2015 the patient complained that she was feeling tingling in her left neck, left elbow, and left little finger. She had her vns turned off because of these symptoms. The patient requested removal of the vns. Additional clinic notes were received which indicate that the patient feels the vns is not working for her. The patient reported numbness to the arm and feels like it is on fire. Good faith attempts for further information from the physician have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5239410


Title: Re: Arms
Post by: dennis100 on December 16, 2015, 10:28:03 AM
Model Number 102
Event Date 08/22/2014
Event Type Malfunction
Event Description
It was reported that the patient's surgery was cancelled because device diagnostics were within normal limits. The generator was programmed back on.

Event Description
It was reported that the vns patient was experiencing pain in his neck and arms. Diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient had recently experienced a drop seizure which may have affected the patient¿s device. Following the drop seizure, the patient began experiencing an increase in seizures. During stimulation on-times, the patient experienced epiglottis contractions, itching around the neck, spasms of the left arm and pain the left arm. The patient stated that he was able to feel the electrical pulse from his device travel through the lead. X-rays were taken and no lead breaks were found; however, the physician stated that the electrodes appeared misaligned on the patient¿s nerve and suspected a partial detachment or shift of the electrodes. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. 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. It was noted that the electrode alignment on the vagus nerve did not follow a straight line. Based on the images provided, the cause of the reported events cannot be determined. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4113291


Title: Re: Arms
Post by: dennis100 on December 19, 2015, 09:57:40 AM
Model Number 103
Event Date 04/22/2014
Event Type Malfunction
Manufacturer Narrative
Only the generator was replaced.

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
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.

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
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253


Title: Re: Arms
Post by: dennis100 on December 20, 2015, 03:12:04 AM
Model Number 102
Event Date 04/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that the patient's seizures have had more movement to them. It was noted that the patient's arm mostly "goes forward". The patient was last seen in (b)(6) 2013. It was noted that the patient has been compliant with medications. The relationship of the more movement with seizures to vns is unknown. The patient was referred for prophylactic generator replacement. No additional relevant information has been received to date. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3815845


Title: Re: Arms
Post by: dennis100 on December 20, 2015, 12:19:20 PM
Model Number 103
Event Date 03/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing an increase in seizures and pain in her arm in the beginning of (b)(6) 2014. Clinic notes were received for the patient¿s office visit with her neurologist on (b)(6) 2014. The patient was having frequent nonconvulsive seizures until starting her medication in (b)(6) 2013. The notes indicate that the patient had good control with grand mal seizures in the past; however, the patient had three grand seizures in the past eight days with the second seizure occurring three days ago and the third seizure occurring the day as the office visit. The patient last grand mal seizure occurred in (b)(6) 2013. The patient¿s seizures occurred in the morning and lasted 1-2 minutes. The patient reported having good quality of sleep and a manageable stress level. The patient did not use her magnet and was tolerating stimulation well. The patient¿s medication was increased and her device settings were adjusted. The patient¿s device was tested during the office visit and diagnostic results revealed normal device function at the time. No programming changes, medication changes, or other external factors preceded the onset of the increase in seizures. X-rays were taken and were reported by the physician to be unremarkable. The patient¿s device was tested on (b)(6) 2014 and diagnostic results revealed normal device function at the time. The patient¿s side effects were inconsistent and not in common with the pain in her arm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3787965


Title: Re: Arms
Post by: dennis100 on December 26, 2015, 11:29:56 AM
Model Number 102
Event Date 09/12/2011
Event Type Injury
Event Description
On (b)(6) 2013, it was reported by the patient that the pain she was experiencing was causing her depression to increase. She stated that she wanted the device explanted. Attempts were made for additional information on the pain; however, they were unsuccessful. No additional information has been provided. Surgery is likely, but has not occurred to date.

Event Description
Product analysis of the generator was performed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. In addition, 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. A cut was identified in the positive coil. Although, not conclusive, it appears this observed condition is the result of the explant procedure. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Dried remnants of what appeared to be dried fluid was seen inside the inner tubing. There was no obvious point on entry other than the cut ends and the mentioned cuts. Other than the above mentioned observations typical wear, and explant related observations, no anomalies were identified in the returned lead portions.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent full explant on (b)(6) 2013 due to pain the chest and arm although the device had not been disabled for some time. The lead and generator were returned on (b)(4) 2013 and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3473303


Title: Re: Arms
Post by: dennis100 on December 30, 2015, 05:51:37 AM
Model Number 102
Event Date 05/22/2010
Event Type Death
Event Description
It was reported that the treating vns physician's office had not seen the patient since 2010 and had not future appointment. Upon review of the internet, the patient's obituary was found which reported the patient passed on (b)(6) 2010. Review of the company programming history database shows that the treating physician programmed the patient's device on (b)(6) 2010 and increased the output current at that time. Attempts for additional information from the physician have been unsuccessful to date. Follow-up with the funeral home revealed that it is not believed that the vns devices were explanted prior to burial.

Manufacturer Narrative

Event Description
It was reported that the cause of death was due to a subclavian clot and that the patient experienced a swallowing disorder and seizures. The hospital medical records indicated that the patient was hospitalized prior to the patient's death from (b)(6) 2010 and was diagnosed with dvts in the upper arms, respiratory distress, seizure disorder, dyspnea, altered mental status, gastro-esophageal reflux disorder and paranoid schizophrenia. It was reported that the patient was in hospice care at the time of his death, but that there are no records in the medical records office from that time. It was reported that the patient was buried and was most probably buried with the vns still implanted. It was reported that the vns helped the patient's seizures. Additional hospital notes were received from the hospitalization prior to death indicating that the patient was observed to have stopped breathing and was pronounced death on (b)(6) 2010. It was noted that the overall clinical impression was that the patient had respiratory failure and lactic acidosis secondary to recurrent aspiration pneumonia. The death certificate listed seizure disorder as the cause of death due to (or as a consequence of) swallowing disorder with aspiration, due to (or as a consequence of) subclavian vein thrombosis. The manner of death was listed as natural. No autopsy was performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232880


Title: Re: Arms
Post by: dennis100 on January 03, 2016, 12:51:56 AM
Model Number 103
Event Date 04/10/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 indicated that this vns patient had an event that was not typical that involve the same jerking motion but it did not cluster. The patient's seizures typically occur in clusters. During the events, the patient will quickly jerk her arms and legs, typically pulling them in. Sometimes only one arm will pull upward and this can be at slow rhythm or quick, rapid jerks. A cluster of these events will last 7-10 minutes resolving in return to baseline. The second type of event has only occurred twice and involved the same extremity jerking but the patient holding her breath during the jerk. This event occurred three weeks prior to for the first time and lasted 7-10 minutes, like the jerking events. The third type of event involved staring straight forward, possibly slightly upward, while she is non-responsive. This occurred two weeks ago while the patient was hospitalized. The event last 40 seconds and involved arrested behavior including sucking on her pacifier. The device was reportedly at end of service no longer providing a charge. These events had increased over the last few months, likely correlating with battery failure on the vns. The patient was referred for generator revision. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.
Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the patient underwent a generator replacement on (b)(6) 2013 due to end of service. The explanted generator was returned for product analysis on (b)(6) 2013. Product analysis on the generator was completed on (b)(6) 2013. Review of the data indicated that the pulse-disabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118624


Title: Re: Arms
Post by: dennis100 on January 03, 2016, 03:24:41 AM
Model Number 103
Event Date 01/13/2010
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 indicated that the patient suffered from seizures, headaches, and hemiparesis. Clinic notes dated (b)(6) 0213 indicated that the patient experienced increased back pain and that her hips were still sore because of injections. Clinic notes dated (b)(6) 2013 indicates that the patient had increased back pain with a possible event in her hips. The patient had to use her magnet over the last few days. Additional information was received indications that provided recent diagnostics results. The patient was referred for generator replacement. Surgery is likely but has not taken place.

Event Description
The generator analysis was completed on (b)(4) 2013. 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. In the pa lab, 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2013, it was reported that this vns patient was having breakthrough seizures and now feels tired all the time. The patient reported that the generator was put in arm pit, a pointy thing sticking out of the armpit that she had to get used to. The patient wasn't sure if the surgery caused nerve damage for she had a problem with her arm for 1 year post operatively and could not move her arm. Surgery is likely but has not taken place.

Event Description
On (b)(6) 2013, this vns patient underwent generator revision. The explanted generator was returned on (b)(4) 2013 and is pending analysis.

Manufacturer Narrative

Event Description
Additional information was received that the patient¿s arm paralysis was approximately six years prior. The event had resolved, was no longer an issue, and was not believed to be related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3106886


Title: Re: Arms
Post by: dennis100 on January 19, 2016, 02:00:05 AM
Model Number 102
Event Date 05/09/2012
Event Type Malfunction
Event Description
On (b)(6) 2012, product analysis was completed on a generator that had been explanted due end of service. The reported end of service allegation was duplicated in the pa laboratory. The supply current tests did not meet functional specifications; these measurements demonstrate an increased current consumption for the device. The increased current consumption was isolated to a leaky capacitor (c6). With the capacitor substitution for c6, the pulse generator module performed according to functional specifications. The cause for the c6 capacitors increase in leakage could not be determined. Clinic notes from the vns patient's clinical visit on (b)(6) 2012 were received which indicated that since the last visit on (b)(6) 2011, the patient has had ongoing seizures. In (b)(6) 2011, the patient had onset of leg tremors that were initially thought to represent clonus, but these progressed to involve his arms and legs and sometimes his face. The patient has had no change in consciousness, but does get agitated during these spell; duration 20-60min. Otherwise, the patient has an average of one seizure every 2 weeks lasting 5-10minutes, described as facial grimacing/twitching and myoclonic jerks. Swiping the vns magnet is no longer effective in stopping/reducing the duration of the patient's seizures. The patient takes tranxene 3. 75mg tablet as needed with increased seizures. The patient receives vns stimulation that is programmed to deliver output=1. 5ma/on time=30sec/off time=1. 8min/pulse width=500usec/frequency=30hz/magnet on time=1. 75ma/magnet pulse width=500usec/magnet on time=60sec. The patient tolerates these without any adverse effects. The patient was noted to be more agitated and has a baclofen pump. There have been no changes in his medications or environmental changes. The physician noted that he attempted to interrogate the patient's vns on this visit but was unable to do so with two different systems. The patient was noted to continue to have breakthrough seizures several times a month, but overall his seizure control has been fairly stable. The vns was stated to be at end of service and was not delivering any stimulation. The patient's mother feels the vns has been efficacious for the patient's seizure control and wanted the vns replaced. The patient was again noted to be more agitated over the past few months for unclear reasons but the physician stated that it is possible that his mood was improved with vns and since he is no longer receiving any stimulation, it has deteriorated.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2828542


Title: Re: Arms
Post by: dennis100 on January 20, 2016, 07:23:52 AM
Model Number 102R
Event Date 10/09/2012
Event Type Injury
Event Description
Additional information was received from the patient's surgeons office in regards to culture results in the patient's vns generator pocket. Rare white blood cells, no bacteria seen.

Event Description
It was reported by a vns implanting surgeon that his patient was in hospital with an infection at the generator site. The patient recently had a battery replacement for end of battery life on (b)(6) 2012. On (b)(6) 2012 - the mother reported that her child was fine and no sign of any problems. Somewhere in between tuesday and friday, he began to lose appetite, get sick, developed a low-grade fever, then had redness and swelling at incision site. No report of any draining or bleeding. He was taken to the emergency room and given iv antibiotics and then po clindamycin. The patient was then told to return to ent surgeon first thing (b)(6). On (b)(6), it was reported that the patient was doing better now, has increased appetite and the fever is down. The incision is healed and intact, however, there is still redness and swelling - a fluid-like feeling around the incision. The surgeon reported that he recalls a hard calcification during surgery that had formed around first generator and he removed it during the replacement procedure. He feels some fluid may have accumulated and gotten infected. They did take blood cultures. He planed to admit the patient into the hospital for a couple of days and administer iv antibiotics. (b)(6) the surgeon reported patient is overall a 'lot' better, fever is gone, skin has cleared except for a slight pinkish color localized to generator. Fluid collection is down and he can feel the generator. The surgeon was keeping the patient in hospital on iv antibiotics until 18th, then releasing on antibiotics po. The surgeon planned to aspirate fluid collection around the generator in a week, unless the patient worsened. If patient's infection worsened, he would explant their generator and attempt to salvage the lead. The surgeon is attributing the event to surgery - in particular, the result of the removal of hard calcification that had formed around the generator. He feels that may have left the tissue raw, and caused fluid to collect. He didn't feel it was due to any interaction from the patient. The patient's generator extruded and it was explanted on (b)(6) 2012. Good faith attempts are underway to obtain culture results.

Manufacturer Narrative
This information was inadvertently left off of mfr. Report #3.

Event Description
The lead was explanted and replaced on (b)(6) 2013.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization prior to shipment of their generator.

Event Description
Clinic notes dated (b)(6) 2012 were received which summarize the reported infection event. On the patient's last visit to vns battery was dead. Patient had been vns generator battery replaced on (b)(6) 2012, that got infected seen and er at enterprise treated with clindamycin developed cellulitis and subsequently had incision break down and had the procedure done for removal of the vns generator. The notes state that the patient came in on this day for a follow up after having the vns stimulator removed. Two weeks after the patient had a battery implant, he had developed a severe infection for which he was placed on vancomycin iv from (b)(6) 2013 to (b)(6) 2013. This infection progressed to the degree that he could not lift his arm. This continued to progress to the point that the suture line ruptured and the entire stimulator pushed out of his skin. He ended up having it removed on (b)(6) 2013 and stayed in the hospital until (b)(6). He has completed a course of two weeks of clindamycin after being hospitalized and he is no longer on abx. Since the surgery, he initially had an increase in seizure activity but that has decreased to his baseline levels. He continues to have one to two of his more severe seizures per week with other petit seizures interspersed. His lead remain in place at this time.

Event Description
It was reported that prior to lead replacement and generator implant surgery the patient's wbc count was "a little elevated". The patient had a temperature of 100. 4 degrees following the surgery at 10pm and then by 3am the temperature was 104. 2 degrees. It was reported that the fever broke between 3 am and 6 am that morning.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2822202


Title: Re: Arms
Post by: dennis100 on January 25, 2016, 12:45:13 PM
Model Number 102
Event Date 12/12/2006
Event Type Injury
Event Description
It was reported that the patient had her vns explanted on (b)(6) 2012 when it was originally believed that she would be getting a replacement surgery on that date. Follow up confirmed that a replacement system was not implanted. It was mentioned that the generator may have been at end of service and that the patient did not believe the device was helping her. Product analysis on the generator was completed on (b)(6) 2012. 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 generator performed according to functional specifications and no anomalies were found. Product analysis on the lead was completed on (b)(4) 2012. The lead connector had detachment at the ring/backfill interface. Both the positive and the negative coil were retracted against the connector ring assembly and in contact inside the connector boot resulting in a short circuit condition. Based on the appearance of the lead, it is believed that this condition was most likely caused during 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 portions. On (b)(6) 2012 a vns implanting surgeon reported that the patient came to him to get her vns removed because it had already been determined by her neurologists that the device was not working and she did not want to go to her previous surgeon. Per the surgeon, the patient also expressed that the device was giving her pain. It was reported that the patient began having pain at the site of the vns immediately after her initial surgery and that the pain radiated to her left hand as well. This occurred 24/7 and affected how the patient sat, moved, and performed day to day activities. The pain was described as a "shocking"; sensation involving the arm and the shoulder. The patient notes that she cannot hold a coffee cup or wash dishes because she has "charley horses"; of the neck along the course of the vns wire. The patient also stated that she cannot turn her neck because it feels "squeezed tight"; and her whole chest tightens up. Per the surgeon, the neurologist had turned off the vns three months prior, however despite the shocking component of the pain becoming less often; she still had a frequent pain. During the time the vns was working, the patient did not recall the pain occurring solely during stimulation time, and the seizures did not increase once the device was turned off. The surgeon was unsure if the patient's symptoms could be explained based on the vagus nerve stimulator. He indicated that there are no nerves that go from the area of the vagus nerve or the left subcutaneous anterior chest to the left hand, so he could not explain most of the patient's symptoms based on the presence of the device. In addition, the fact that the symptoms persisted even when the device was turned off was additional evidence that the patient's current symptoms were not caused by the device and that removal of the device would not make her symptoms go away. On the other hand, the patient was quite clear that her symptoms began immediately after implantation of the device, so the surgeon explained that it was possible that the surgery to implant the device could have triggered the onset of symptoms. Follow up was performed with the neurologist, however, they stated that he had not seen the patient since (b)(6) 2011 and had no information on the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2763658


Title: Re: Arms
Post by: dennis100 on January 30, 2016, 02:22:34 AM
Model Number 102
Event Date 05/30/2012
Event Type Injury
Event Description
Additional information was received on (b)(6) 2012. It was indicated that the migration was first noted on (b)(6) 2012. There was no trauma or manipulation however; the patient may have lost some weight which might have contributed. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported by the surgeon's office that the patient's generator has migrated and is causing the patient arm discomfort. The patient has been referred for surgery to reposition the generator. Follow up was performed with a nurse at the surgeon's office, but she was unsure if there had been any manipulation or trauma to the device. She also was unable to determine if a non-absorbable suture was used during implant to secure the generator. Attempts for additional information have been unsuccessful to date. Surgery is likely but has not occurred to date.

Event Description
Information received on (b)(6) 2012, indicated that the patient underwent a generator re-positioning surgery on (b)(6) 2012, to resecure the generator. No devices were replaced at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2649568


Title: Re: Arms
Post by: dennis100 on February 01, 2016, 01:38:57 AM
Model Number 102
Event Date 03/01/2012
Event Type Malfunction
Event Description
Lead product analysis was approved on (b)(6) 2012. The lead assembly was returned for analysis. Note that since the electrode array portion 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 portion. A section of the lead assembly was returned for analysis in two pieces. The lead's electrodes were not returned for evaluation. Two tie-downs were returned with the lead. Inspection of the first portion of the returned lead showed that setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. An abrasion was identified on the connector boot. The lead assembly appears to have been cut at near the end of the connector boot. The lead coils are cut/torn at this location. Inspection of the second portion of the returned lead showed that abrasions most likely caused by the presence of a tie-down were identified. Abrasions were identified on the outer silicone tubing at multiple locations. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the ends of the returned lead portions. Generator pa was approved on (b)(6) 2012. The generator did perform according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "pain"). Testing demonstrated proper device functionality (in both programmed and "on-demand" operational modes) including outputs that meet specifications. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. No performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2012, this vns patient reported that she was hospitalized last month due to incontrollable seizures. The patient reported that problems with device pain began around (b)(6) 2012, and the problems have continued. The patient reported that she had a stroke last month and is unable to move her left arm and left leg. At the time of the report, the patient was receiving physical therapy in her home. An mri was likely to rule out stroke. The patient underwent generator and lead explant on (b)(6) 2012. The electrodes were not removed as they were scarred in. The explanted lead and generator were received on (b)(6) 2012 and are currently undergoing product analysis.

Event Description
On (b)(6) 2012, this vns patient reported that a surgeon would be removing the generator and "snipping" the leads. The patient was unsure if she would be undergoing explant or revision. The patient last met with her neurologist (b)(6) months ago ((b)(6) 2012), at which time the settings were increased. The patient reported that she was having some pain in the neck (like it was poking through), throat tightening, continuous pain in the chest, the generator moving around in her chest when she lays on her side, and tingling in the arm and hands, which causes her to not lift her arm. The patient stated that the issues began one and a half months ago ((b)(6) 2012). The patient stated that the only traumatic incident that occurred just prior to the events was getting her hair washed in the sink at the hair dresser. The patient stated that the positioning may have pulled on her device or positioned her in an awkward way. The patient met with her neurologist's pa (physician's assistant) and was prescribed pain medication to which the patient had an allergic response. The pa referred the patient to the surgeon because her "device was messed up" and was causing these issues. The patient stated that no diagnostics were performed at this time. Attempts for additional information are underway.

Manufacturer Narrative
Review of programming/device diagnostic history performed.

Event Description
The physician did not believe the patient's stroke was related to vns.

Event Description
On (b)(6) 2012, the surgeon and patient reported that following information: the pain in the neck, lead protrusion, and pain in the chest began shortly after the vns surgery. The patient bent down to get something and injured her back. The physician stated that the back pain is not related to the vns, and it was probably a coincidence that it occurred close to the date of surgery. The throat tightening began after the patient's settings were adjusted by a physician in another state. The neurologist adjusted the pulsewidth, and the throat tightening ceased. The tingling in the arms and hand occurs when the patient lies on her left side. The patient reported experiencing feeling this for some time but did not have an exact date. The patient reported lateral migration of the device and stated that it was sitting on her right pectoral muscle. The patient experiences pain from this when moving her left arm. The patient did not know on what this date event began. The pain in the neck, lead protrusion, and pain in the chest were reported to have no relationship to vns. The throat tightening was experienced with stimulation; however, reducing the puslewidth resolved this issue. The tingling was reported due to the lateral device migration interventions for the generator migration included a referral from the surgeon to revise the generator to a newer model and move the generator. No interventions have been planned for the tingling. Aside from the throat tightening due to increased pulsewidth, no causal or contributory programming changes, medication changes, patient manipulation, patient trauma, or physiological changes (i. E. Weight loss) preceded the pain in the neck, lead protrusion, pain in the chest, tingling in the arms and hands, and generator migration. The patient has no history of pain in the neck or chest, throat tightening, or tingling pre-vns. It is unclear if a non-absorbable suture was used to secure the generator fascia during implant as the surgery was performed at another facility. Normal mode and system diagnostics indicated "ok" lead impedance and that the battery was not at end of service. The reference the patient made to the generator being "messed up" was clarified by the surgeon. The surgeon reported that it is likely that the pain she is experiencing is due to device size and migration and is recommending the device be replaced with a 103. The patient's output current was reported to be 0. 75 ma. The surgeon also recommended a revision from a model 102 generator to a model 103 generator and movement of the generator placement. The patient reported that the device was helping and that she did well at settings from her previous physician; however, her current physician has reduced the settings, and, as a result, she is experiencing more seizures. Additional information was received on (b)(6) 2012, that the patient's increase in seizures was below the pre-vns baseline. On (b)(6) 2012, the implanting surgeon confirmed that a non-absorbable suture was used during the initial implant of the device. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2597650


Title: Re: Arms
Post by: dennis100 on February 02, 2016, 07:00:14 AM
Event Date 04/10/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, follow up with the surgeon revealed that the patient's device was explanted on (b)(6) 2012 and reimplanted on (b)(6) 2012. Cultures were taken and returned positive for infection. The surgeon stated that a granuloma formed in reaction to the silicone tie-down at the lead site. The granuloma was removed, down to the wire. (the date of the granuloma removal was unavailable. ) the site continued to be infected. As a result, the patient's device was explanted. Attempts for product return and additional information have been unsuccessful. The hospital could not locate the explanted devices.

Event Description
On (b)(6), 2012, confirmation was received that the patient underwent surgery on (b)(6), 2012. On (b)(6) 2012, additional information was received that the patient had a full system put in and that the patient had been explanted due to an infection. It is unclear if the patient underwent explant on this date or at a previous surgery. Attempts for product return and additional information are underway.

Event Description
On (b)(6) 2012, a patient's father reported that the patient's lead was extruding in the neck. No trauma or manipulation was reported. Earlier that day, the patient went to his primary care physician at which time the physician pulled the skin back over the site and sewed everything up. The patient's father provided images of the extrusion. Clinic notes were received on (b)(6), 2012 from two of the patient's appointments. (b)(6) 2012 notes reported that the patient had a generalized tonic-clonic seizure (gtcs) on (b)(6), 2012. The gtcs were usually triggered by lack of sleep. The seizure frequency was two per month. (b)(6), 2012 notes reported that the patient received a tingling sensation with stimulation and had about two general tonic-clonic seizures per week. On this occasion, the physician decreased the normal and magnet output currents and the normal pulsewidth. On (b)(6), 2012, the following information was received from the neurologist's office: no causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures or the lead body extrusion. The patient's medication was increased to handle the increase in seizures, but interventions for the lead extrusion were unknown as the patient was referred to a surgeon. The relationship of the increased seizures and lead extrusion to vns is unknown; however, the patient's pulsewidth and output current were decreased. The lead extrusion was first noted on (b)(6), 2012, and no patient manipulation or trauma was known to cause the lead extrusion. Diagnostic results were unknown, as was the pre-vns seizure frequency. No product information (model/serial number) was available. On (b)(6), 2012, information from the surgeon's was also received via phone. This information was also confirmed in clinic notes received on (b)(6), 2012 and dated (b)(6), 2012. It was reported that the patient experienced consistent swelling in the neck a few months prior. The patient was sent for excision of the pyogenic granuloma. No cultures were taken, but the patient was started on clindamycin. The area continues to drain blood and purulent material. At the time of the surgical procedure, the wires were exposed. Since that time, he has felt a shocking sensation in his arm and neck at times. Prior to vns, the patient was experiencing 7-10 grand mal seizures per day which has decreased to approximately one per month. The physician's assessment of the patient was a chronic neck infection after vns placement. The patient was scheduled for explant on (b)(6), 2012 with afb and fungal cultures to follow. It was recommended that the patient have at least two weeks of treatment prior to replacement. Attempts for the return of the explanted products will be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2585568


Title: Re: Arms
Post by: dennis100 on February 03, 2016, 10:27:26 AM
Model Number 102
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative
Analysis of programming history performed.

Event Description
It was initially reported on (b)(6) 2012, that a vns patient wanted to have her device removed because the battery was dead and when she works out, it causes some pain in her arm. The patient later stated that the vns device never really helped much and was also causing numbness and pain in her arm. Good faith attempts to obtain additional information were unsuccessful. During a review of the patient's programming data available in the in-house programming database, it was noted that the device was programmed off on (b)(6) 2010, however this was the last date of data so it is unknown if the device was programmed back on at a later date or if has remained off. The generator was explanted and not replaced on (b)(6) 2012. The generator will not be returned to the manufacturer for analysis.

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the explanted generator was available for return. The explanted generator was returned to the manufacturer on (b)(4) 2012 and product analysis is underway.

Event Description
Additional information was received on (b)(6) 2012, when analysis of the explanted generator was completed. During the analysis, it was observed that the septum was not cored thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2535518


Title: Re: Arms
Post by: dennis100 on February 11, 2016, 02:28:29 AM
Model Number 102
Event Date 09/01/2011
Event Type Injury
Event Description
On (b)(6), 2012 clinic notes were received through case management. Review of the clinic notes dated (b)(6), 2012 revealed that the vns patient has been experiencing daily partial seizures. The vns generator battery was reported to be depleted. The patient was referred for replacement. The patient stated that she has never been able to feel the vns activate but remembered that her previous neurologist told her last year that it was almost time for her to have a generator replacement. The clinic notes also state that the patient has been having some hives on her elbows and knees since (b)(6) 2011 and that in (b)(6) 2012. Her face became swollen and she had to go to the emergency room. She took steroids and it got better but periodically she has eye swelling and hives all over, the patient worried that her medication lamictal may be the cause. The physician later reported that the patient was only seen by him on (b)(6), 2012 but the patient reported increased seizures for the last 6 months. He did not have any diagnostic results as they only saw the patient once. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increased seizures. He said they interrogated her vns at this appointment and saw that the battery was dead. A battery life calculation was performed with the programming history available which showed a remaining time of negative years until the elective replacement indicator showed yes. Although surgery is likely, it has not yet occurred.

Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. In the product analysis lab, 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 battery was confirmed to be depleted at eri (elective replacement indicator)=yes in the product analysis laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2493133


Title: Re: Arms
Post by: dennis100 on February 15, 2016, 03:48:48 AM
Model Number 102
Event Date 08/29/2011
Event Type Injury
Manufacturer Narrative
Date of birth, corrected data: the initial report inadvertently reported the date incorrectly. Date received by manufacturer, corrected data: the supplemental report #7 inadvertently reported the date incorrectly. It should have reported the date as 10/24/2014.

Event Description
It was reported that a vns pt had swelling in his arms and legs around the time of vns implant on (b)(6) 2011 through (b)(6) 2011. The pt went to the er in (b)(6) 2011, and the physicians found that he had a blood clot in his arm and one in his leg. He was hospitalized at that time. During this hospitalization, the pt was diagnosed with one of his heart valves not opening. The pt indicated that he thinks these events are all related to vns. The pt has reportedly not had his vns checked in a while and probably will not until the blood clots and heart valve problem resolve. Attempts for add'l info from the physician have been unsuccessful to date.

Event Description
Additional information was received from the surgeon who reported that the patient's reported additional health problems are not related to vns. The patient has been referred to a vascular specialist, but the patient has not followed up.

Event Description
The patient reported that the patient wants to the vns device explanted because it caused him to have blood clots. The patient indicated that he has had the device disabled 'for a period of time. ' the patient is reportedly now on coumadin, and continues to report that his health has declined with vns. He plans on reducing coumadin in anticipation of vns explant. Attempts for additional information on the device disablement have been unsuccessful to date.

Event Description
It was reported that the patient had the generator and lead explanted on (b)(6) 2014. The explanted products have not been received by the manufacturer to date.

Event Description
Additional information was received from the epileptologist's office which revealed that they are unable to provide an assessment regarding the relationship of the patient's heart conditions to vns. It was noted that the patient's vns system has been working properly and no changes have been made to the patient's medication or the vns settings. They are unaware if any interventions have been planned or if the patient had a medical history of blood clots or heart problems. The surgeon's office reported that the patient's blood clots, swelling and heart valve problems are not related to vns. The patient has been referred to a vascular specialist regarding these events. No causal or contributory medication changes precede the onset of these events, and the patient does not have a medical history of these events. Patient manipulation or trauma may have occurred to have caused/contributed to the swelling. No additional information was provided by the surgeon. The patient further reported that he has seven blood clots, and has swelling in his legs and left arm, which he didn't have before vns. The patient says that with vns, he is having more health problems than what he wants. Attempts for additional information from the surgeon have been unsuccessful to date.

Manufacturer Narrative
The supplemental report #1 inadvertently did not include that the patient now reportedly has seven blood clots.

Event Description
It was reported that the patient has seven blood clots and has swelling in the legs and left arm, and the patient did not have these blood clots and swelling prior to vns. Attempts for additional information from the surgeon's office have been unsuccessful to date.

Event Description
It was reported by the explant hospital that the explanted products were discarded.

Event Description
Information was received from the neurologist¿s office that in clinic notes dated (b)(6) 2012, it was documented that the device was off. The nurse was unable to find when it was first turned off. An additional attempt for information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465251


Title: Re: Arms
Post by: dennis100 on February 16, 2016, 03:04:56 AM
Model Number 304-20
Event Date 11/02/2011
Event Type Injury
Event Description
It was reported that a patient had numbness on her left and right shoulders, arms, and hands. The patient also reported pain in the same area as well as pain in her neck. Per the patient, she never had these problems prior to being implanted with vns. It was believed that the patient may have some nerve damage or a compressed nerve. It was noted that during initial implant surgery, there was excess blood in the chest due to the tunneling process however no main artery or view as affected. Additionally, x-rays were taken by the surgeon during the implant procedure and everything appeared okay. The patient was initially fine after surgery as during follow up appointments a few days after implant, the patient was okay and everything was said to be normal. Good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda. This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, cyberonics, or cyberonics; employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any defects or malfunctions. These words are incorporated into the fda 3500a medwatch form by the fda, and cyberonics objects to their use.

Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient is still experiencing the numbness in her left and right arms. The settings were 0. 75/20/250/30/3. Diagnostic results were said to be within normal limits however the specific test results were not provided. The patient was also having difficulty breathing. The plan was to program the patient's device off. Follow up with the physician revealed that the pain (shoulder, arms, hands) was related to vns (stimulation). The patient does have a medical history of shoulder/arm/hand pain prior to being implanted with vns. Systems diagnostics gave acceptable results however the specific test results were not provided. The device was programmed off to prevent a serious injury. The device was programmed off on (b)(6) 2012 and the patient wants the device removed however surgery is not scheduled at this point to his knowledge. He did not have any additional information to provide other than the patient is having anxiety and panic attacks because of the issues with her vns. He could not elaborate further or either of those events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2435388


Title: Re: Arms
Post by: dennis100 on March 01, 2016, 05:02:24 AM
Model Number 102
Event Date 08/22/2011
Event Type Injury
Event Description
Attempts for additional information regarding the patient's reported pain and migration have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was initially reported that the patient was complaining of pain and twitching in his arm, occurring with stimulation. Additional information was received indicating that the patient was experiencing electrical stimulations in the chest area. Diagnostics were performed and reported to be within normal limits, however no specifics were provided. X-rays were also performed but it is unclear if they will be sent to the manufacturer for review. The patient's device was not disabled, as the patient's neurologist felt that the vns was successfully controlling the patient's seizures. The patient was however referred to a surgeon for possible full revision. Surgery took place on (b)(6) 2011. During the procedure, the lead wire was found to be intact; however the generator was loose in the chest. The old generator was removed and a new generator was securely implanted. The explanted generator has not yet been returned to the manufacturer for analysis. On (b)(6) 2011, it was reported by the patient's surgeon's office that the patient has developed an infection at his generator site, following the replacement surgery. This will be reported under mdr number: 1644487-2011-02286.

Event Description
Additional information was received on (b)(6) 2011, indicating that the pain that the patient was experiencing was attributed to the generator movement in the chest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266994


Title: Re: Arms
Post by: dennis100 on March 03, 2016, 04:12:30 AM
Model Number 103
Event Date 07/12/2006
Event Type No Answer Provided
Event Description
On (b)(6) 2011, a vns pt reported that she was experiencing painful stimulation and that it feels as though her breast is being "shocked". She said that she has had painful stimulation since the original implant on (b)(6) 2006. She had a battery replacement on (b)(6) 2011 and she is still experiencing the painful stimulation. The pt reported that the pain used to radiate down her arm but it is not as bad now. She said that the physician ran diagnostics but did not see any problems. As far as efficacy, she reported that she has not had a seizure in four years with vns. The physician's nurse later reported that the pt is having a breast reductions surgery at this time and after that procedure they are going to look into the pt's painful stimulation. The nurse reported that they were not going to provide any further information. Good faith attempts for product information from the implanting hospital were made but no information has been received to date. If additional information is received, it will be reported.

Manufacturer Narrative
Initial mdr inadvertently listed wrong product.

Event Description
Additional information was received on (b)(6) 2011 when the implanting hospital provided the patient's generator product information. On (b)(6) 2011, the vns patient reported that a surgeon had scheduled her for breast reduction surgery on (b)(6) 2011 but that on (b)(6) 2011, the surgeon backed out of the surgery. The surgeon told the patient that he was worried that he might damage the vns device and had no assurance that insurance would replace it and could not subject the patient to seizures. The patient reported that he did not allow another colleague to review the case and stated that she should seek a university setting. The patient reported that she wants a breast reduction because there is tension on the vns device that is causing pain even after the device was moved in (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2228172


Title: Re: Arms
Post by: dennis100 on March 10, 2016, 05:07:23 AM
Model Number 103
Event Date 01/05/2011
Event Type Injury
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that the vns pt is scheduled for a full revision surgery in (b)(6) 2011. The pt have been experiencing pain to her neck upon stimulation since her battery replacement surgery in (b)(6) 2011. The pt has about 1. 3 years left of battery life and a lead impedance value of 2278 ohms. The pt also said that she was experiencing pain in both arms since the battery replacement surgery in (b)(6) 2011. The physician reported that the pt is at high settings but that diagnostic results are within normal limits. No change in medication or settings and no trauma or manipulation to the device occurred. Clinic notes from the physician were rec'd review of clinic notes dates (b)(6) 2011 report that the pt is complaining of pain in the chest and left arm due to vns. The clinic notes also state that the pt is having more seizures and that the vns magnet is not kicking in. The clinic notes reveal that the pt was being referred to a vns implanting surgeon for a second opinion regarding the vns causing chest and left arm pain. Additional information regarding the pt's pain and seizures has been requested from the pt's physician; however, no further information has been rec'd to date. When additional information is rec'd, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133616


Title: Re: Arms
Post by: dennis100 on March 21, 2016, 12:24:11 AM
Event Date 11/19/2010
Event Type Injury
Event Description
It was reported that the pt had her settings turned down due to pain at the electrode site in her neck, down her back and in her arm and leg. She has also experienced an increase in seizures recently and the magnet has had no effect. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1938613


Title: Re: Arm
Post by: dennis100 on March 24, 2016, 07:18:27 AM
Event Date 08/01/2010
Event Type Injury
Event Description
It was reported that the patient's generator rotates up when the patient turns her shoulder a certain way. Diagnostics are all okay and the patient feels stimulation like normal. The patient's seizures are well-controlled, but the patient would like to meet with a surgeon to possibly place the generator in a different location, under the muscle, to keep it from rotating when she moves her arm. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1843802


Title: Re: Arm
Post by: dennis100 on March 25, 2016, 02:12:00 AM
Model Number 102
Event Date 07/30/2010
Event Type Injury
Event Description
It was reported that the pt was in the hosp and was having upper left extremity tremors. The hosp staff and family felt it was happening around pt's vns dosing cycle. Magnet was placed over chest and turned off for 8 hrs and tremors stopped. Pt's settings were decreased to conserve battery life and try to alleviate tremors. Battery replacement surgery is likely, but has not occurred to date. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1822534


Title: Re: Arm
Post by: dennis100 on March 30, 2016, 07:50:59 AM
Model Number 103
Event Date 12/16/2009
Event Type Injury
Event Description
It was reported that a patient began to feel stimulation down his arm and was feeling stimulation at different times following a motor vehicle accident in which he was a pedestrian and was struck by a car. The patient's device was set to send stimulation every 10 minutes, however, the patient reported feeling stimulation at 10 minutes, sometimes at 12 minutes, and other times at 14 minutes. The physician indicated that device diagnostics were performed and the results were within normal limits however, the exact results obtained were not provided. X-rays were taken and reviewed by the physician who stated no discontinuities were found. The patient was referred for generator revision surgery however, the erratic stimulation continued after the generator was replaced. The explanted generator has been returned to the manufacturer and device evaluation is in process. Good faith attempts to obtain additional information regarding the patient's events are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1599286


Title: Re: Arm
Post by: dennis100 on April 09, 2016, 07:01:53 AM
Model Number 101
Event Date 01/01/2009
Event Type Injury
Event Description
It was reported that the pt requested to have his device explanted because he did not want the device anymore. The pt indicated that it "limited his arm movement. " requests for further info from the treating physician were denied. Good faith attempts to obtain additional info have been unsuccessful to date. The device has been returned to the mfr for analysis, but it has yet to be performed. It is unclear at this time what the relationship of the pt's event is to that of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1409410


Title: Re: Arm
Post by: dennis100 on April 21, 2016, 02:33:56 AM
Model Number 102
Event Date 01/01/2009
Event Type Injury
Event Description
Reported indicated that a vns patient would have his vns replaced due to pain under the arm. The pain was believed to be due to the placement of the generator and was not related to device stimulation. There is no suspected malfunction of the device. The explanted generator has been returned to the manufacturer for analysis however, device evaluation has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1310979


Title: Re: Arm
Post by: dennis100 on April 21, 2016, 02:34:32 AM
Model Number 102
Event Date 01/12/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was hospitalized due to painful stimulation in the neck, chest, and arm in addition to a choking sensation with stimulation. The vns device was disabled and the pain was still present, but the dysphagia resolved. Diagnostic tests were performed following the onset of the events, and were reported to be within normal limits. There was no report of trauma, manipulation or other believed cause prior to the onset of the event. As intervention, the physician opted to have the entire device replaced. The explanted lead and generator were returned to manufacturer and analysis underway. Attempts to obtain additional information in regards to the patient status following revision surgery from the treating physician have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1310986


Title: Re: Arm
Post by: dennis100 on June 07, 2016, 12:27:34 AM
Model Number 103
Device Problem No Information
Event Date 04/13/2012
Event Type Injury
Event Description
The physician's office reported that the patient will be undergoing a stress test and ekg and the physician is unsure of the relationship to vns at this time. No additional relevant information has been received to date.

Event Description
The patient reported that she was scheduled to see the surgeon for consult. She indicated that she needs two procedures at the same time. The patient reported that the other procedure she requires is cardiac related for possible stent placement. The patient reported that she had an abnormal ekg, but it may be related to her vns. The patient underwent surgical consult and was referred to a cardiologist. No known surgical interventions have been performed to date.

Event Description
It was reported that the patient experienced choking, increased blood pressure, increased heart rate and voice alteration with stimulation. Patient had gone to the er due to chest pain suspecting a heart issue but was told that the heart was fine. At the er it was found that patient's dilantin level was high and the er staff immediately tried to get her dilantin level down. Additional information was received that the patient's increased blood pressure and heart rate started since (b)(6) 2015. The neurologist referred patient to the surgeon to assess patient's chest pain, increased heart rate and blood pressure. The relationship of these events to vns therapy is unknown to the neurologist. Clinic notes were later received for the generator replacement, which noted that the patient experienced dysphagia, pain in the left upper extremity and burning around the site of vns, which does not radiate in to the neck. Patient's vns was also reported to have moved due to loss of weight. The surgeon did not recommend any changes due to the migration. Notes also indicated that the patient's vagus nerve was impaired with hoarseness. No known surgical interventions have occurred to date.

Event Description
The physician reported that device diagnostics were within normal limits. The patient was encouraged to use the magnet more. The physician indicated that the device is working fine and that the seizures are at the patient's pre-vns baseline and that the patient feels she is still having seizures.

Event Description
The patient underwent generator replacement. The explanted generator has not been received for analysis to date. The physician reported that the patient underwent cardiology consult and a stress test and there was no evidence of abnormality. The physician believes a 3d echo was performed. It was reported that the ekg was ok.
Manufacturer Narrative

Event Description
The patient reported that she is still experiencing issues with her new generator. The patient reported that she is uncomfortable and it still hurts sometimes. The patient reported that she feels like it "jumps" around sometimes. The patient complained to the physician's office regarding erratic stimulation. The patient reported that vns isn't working. The patient reported that she is experiencing an increase in seizures and is concerned that something bad is going to happen to her. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225867


Title: Re: Arm
Post by: dennis100 on June 07, 2016, 12:28:08 AM
Model Number 101
Event Date 08/06/2010
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that before the patient's previous implant on (b)(6) 2011, the patient had some arm posturing and cognitive declines. It was also reported that the patient had a dramatic improvement once that battery was replaced. The explanted generator was received by the manufacturer for analysis. Analysis of the generator concluded that no performance issue or any other type of adverse condition was found. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5228873


Title: Re: Arm
Post by: dennis100 on June 08, 2016, 01:54:30 AM
Model Number 105
Device Problem Migration of device or device component
Event Date 03/23/2015
Event Type Injury
Event Description
Additional information was received form the surgeon's office that the patient was seen and that the surgeon felt that the device was satisfactorily in place and that no surgical interventions are needed. If patient experiences an erythema again, patient was advised to see the surgeon at that time.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient experienced pain when she moves her arm. The physician believes that the generator has migrated laterally and has referred patient for surgical evaluation. Diagnostics were reported to be within normal limits. A non-absorbable suture was used to secure the generator to fascia during implant surgery for this patient on (b)(6) 2015. Additional information was received from the neurologist that the patient experienced pain since approximately early (b)(6) 2015. There was no trauma or other incidents that might have contributed to the migration of the device. The migration is believed to be progressive since implantation or soon after. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5178668


Title: Re: Arm
Post by: dennis100 on June 14, 2016, 09:29:14 AM
Model Number 102
Event Date 04/25/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received indicating that a vns patient was experiencing painful stimulation (a "shocking" sensation) for which the generator was disabled. It is stated that the painful stimulation stops when someone palms her in the back behind where the vns is placed. It is stated that when it shocks her it shocks her down her arm down to her elbow, in shoulder blade area, up into her neck, head, and teeth. She states that moving her left arm sets it off. The patient was then referred for generator replacement evaluation. Review of available data in the programming and history database revealed no anomalies. A battery life calculation performed with available data indicated the device has 8. 5 years remaining until neos = yes although the last 4 years of programming data is missing. Follow up with the provider indicated that the most recent device check was (b)(6) 2016 and when asked for battery status on that date the provider indicated the battery was "failing. " the provider indicated that vns was turned off until the battery could be replaced and increase seizure medication was prescribed until vns can be turned back on. The provider stated that the increase in anti-seizure medication was to preclude a serious injury since the vns device had been turned off awaiting generator replacement surgery although the patient had not actually experienced an increase in seizure. Further follow up with the provider indicated that while the clinic notes did not specifically indicate which battery indicator was observed the providers felt the patient's device was at neos or eos. The physician attributed the painful stimulation to the low battery condition and elected to disable the device output for patient comfort reasons. The provider submitted additional clinic notes containing device settings. An updated blc performed based on the newly submitted settings indicated that the device has approximately 8. 1 years remaining longevity. No device diagnostic data could be found in the clinic notes therefore the impedance status of the system was unknown. The device was subsequently evaluated and found not to be at eos and had normal lead impedance values in 3 different head/neck positions but the providers elected to proceed with generator replacement surgery on a prophylactic basis. The generator was successfully explanted and replaced on (b)(6) 2016 and normal impedance was observed with the new generator attached to the former lead (dc dc 2).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5689538


Title: Re: Arm
Post by: dennis100 on June 17, 2016, 12:50:03 AM
Model Number 103
Event Date 04/01/2016
Event Type Injury
Event Description
It was reported that the patient and his mother were planning to consult with a surgeon on the prospects of getting his vns removed. Information later received indicated that the patient was experiencing pain around his generator site and under his arm. No known surgical interventions have occurred to date. Attempts for additional pertinent information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5655098


Title: Re: Arm
Post by: dennis100 on July 27, 2016, 06:36:07 AM
Model Number 102
Event Date 07/06/2009
Event Type Injury
Event Description
It was initially reported that a vns patient experienced electrical shocking sensations in the chest area. The treating neurologist evaluated the patient's generator and found it to be working within normal limits. Further interventions were to program the patient's generator off. After the generator was programmed off, the patient continued to experience pain around the generator area along with a burning sensation that radiated to the underarm with swelling in the chest. Information received from the treating neurologist revealed the patient went to the er for intervention to be taken due to the chest pain. At the moment, it is known that the event is not related to stimulation, however, the root cause of the events is still unknown. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464539


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 01:37:19 AM
Model Number 103
Event Date 09/15/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had gone to the er on (b)(6) 2016 complaining of dyspnea, coughing, and a tingling sensation in her face and upper extremities. The physician tested the vns and found high impedance. The vns was programmed off and the patient was referred for surgery. The patient underwent surgery to correct the high impedance observed, on (b)(6) 2016. It was noted that the lead pin was not fully inserted into the generator. The lead pin was reinserted; the impedance was checked both outside and inside the generator pocket. Both sets of diagnostics were within normal limits and there was no need for a replacement of either the lead of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6019996


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 01:38:14 AM
Model Number 106
Event Date 09/11/2016
Event Type Injury
Manufacturer Narrative
Occupation, corrected data, initial mdr inadvertently reported incorrect initial reporter occupation.

Event Description
On (b)(6) 2016 an email was received regarding a patient who was taken to the er when he was experiencing an increase in jerking movements in his arm. The patient's parents believe that it may be related to vns so they asked for an appointment with the neurologist to increase the settings. The physician is not sure what is causing the jerking movements or if this is actual seizure activity. Programming changes made: increased autostim to 0. 5ma and decreased the threshold from 40% to 30%. Also decreased the off time to 3min. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6012069


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:08:42 AM
Model Number 102
Event Date 08/01/2014
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2014 indicate that the patient was seizure free until (b)(6) 2014 at which time, the patient began to experience 3-4 seizures per day. The seizures are described as jab/jolt on the right arm and the bladder. Possible triggers were mentioned such as associating the patient's seizures to eating foods that are high in sugar content and obstructive sleep apnea. The patient was referred for generator replacement. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4343352


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:11:28 AM
Number 102
Event Date 07/01/2012
Event Type Injury
Event Description
The patient¿s explanted generator will not be returned for analysis due to the hospital¿s privacy policy.

Event Description
On (b)(6) 2013 clinic notes dated (b)(6) 2013, were received which indicated that the vns patient was admitted to the emergency room on (b)(6) 2013, due to a new seizures type and a new right arm weakness. On the night prior, the patient felt a sudden jerking of her right leg which came up off the bed, followed by her right arm which was shaking as well. The patient stated that it reminded her of a grand mal seizure which she had at age (b)(6), which was unusual for her. The patient's arm became numb, and this was a different seizure, so they wanted to admit the patient after having a head ct which showed abnormalities, nothing acute. The plan was to admit her, and do a video eeg there, thinking that these may be different seizures. It was decided to transfer her, in order to rule out the possibility of stroke, which was doubtful (as this was thought to be a todd's paralysis based on her (b)(6) hmri) but just to make sure there was nothing else going on. By the morning the patient regained her strength in the right hand, suggesting that this was postictal todd's paralysis as suspected. The clinic notes mention that due to the fact that she has been in the er with seizures lately, the last week, and a few other times in the er for other seizures, it may be that she is having a combination of epilespy but also none-epileptic seizures. Clinic notes dated (b)(6) 2013, indicate that the vns battery is at end of service and that before (b)(6) 2012 the patient seizures were picking up, but since (b)(6) 2012, she has had a lot more seizures that are bigger; averaging 2-6 convulsions per month. It was stated that the vns is giving her a little bit of shortness of breath now and then, although she says the symptoms are tolerable. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. A blc was performed which showed 6. 4 years remaining until eri=yes. Good faith attempts for further information from the physician were unsuccessful.

Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #1 did not indicate that the device will not be explanted due to the hospital's privacy policy. The information has been included in this report.

Event Description
An implant card was received which indicates that the vns device was explanted on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3065662


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:14:11 AM
Model Number 102
Event Date 11/13/2009
Event Type Injury
Event Description
It was reported to the mfr that the vns pt went to the emergency room due to a seizure that paralyzed her right arm and right leg. It is unk if the paralysis was permanent or if the event was related to vns therapy. It is unk if any interventions were taken for the reported event. Diagnostic tests performed on the pt's device at implantation surgery revealed proper device function. Good faith attempts to obtain add'l info regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1559750


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:17:11 AM
Model Number 102
Event Date 07/18/2008
Event Type Injury
Event Description
It was reported that the vns pt was hospitalized due to pain in right lower extremity and bumps in the right forearm. The pt was diagnosed with deep vein thrombosis at the level of the popliteal vein and thrombus in the greater saphenous vein. The right upper extremity showed some non-occlusive thrombus in the right cephalic vein. Further follow-up revealed that the pt has a history of thrombosis post surgically, therefore it has been determined by the physician that the event is a result of the implantation procedure, and the event is not related to the vns device.

Manufacturer Narrative
Implantation procedure caused event, no device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1147204


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:21:22 AM
Model Number 104
Event Date 12/01/2010
Event Type Injury
Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2013 that indicated in (b)(6) 2010 the patient was admitted to the hospital with new tongue spasms. Psychiatry recommended effexor with improvement noted. The patient had new spells (b)(6) 2010 of raising right arm, faraway look, fall to the floor; multiple per day which resolved. The patient saw a physician on (b)(6) 2011 and thought to be new focal seizure or nes. The physician later reported that the change in seizure pattern was first observed around (b)(6) 2010. There were "no changes" according to the physician and the seizures were thought to be non-epileptic spells. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the change in seizure pattern.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118534


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:24:06 AM
Model Number 102
Event Date 02/17/2010
Event Type Injury
Event Description
A review of clinic notes dated (b)(6) 2012 found that the patient went to the emergency room the prior week with records from the emergency room dated (b)(6) 2012 showing that she had an increased frequency of seizures. The emergency room records also noted that the patient's white blood cell count in the urine was high suggesting a mild infection. The clinic notes continued to state that the patient had continued to have a change in her pattern of seizures as well described by her husband. The patient's husband stated that the patient seems to have a twisting movement with shaking in the right arm. The patient had one of these seizures during the appointment, and the physician noted that she appeared to be able to move to her husband and that it appears that the patient is seeking comfort from her husband. After the patient's vns was interrogated, an attempt was made to increase the pulsewidth from 250usec to 500usec, but the patient had significant changes in her voice and felt as if there was a sharp, stabbing pain in her neck when the stimulator turned on. Because of this, the stimulator was reversed and the settings were adjusted so that only minor change was made. According to the physician, the battery appeared to be satisfactory and the plan for the future was to adjust the patient's medication. Attempts have been made to get more information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816907


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:27:07 AM
Model Number 302-20
Event Date 07/26/2011
Event Type Malfunction
Event Description
Additional information was received stating that vns patient¿s generator was explanted due to lack of efficiency and lead discontinuity on (b)(6) 2014. The explanted generator and lead were returned to the manufacturer on (b)(4) 2014. Analysis of the generator showed that the it performed according to functional specifications. Analysis of the lead is currently underway. Attempts for additional information have been made, but no further details have been received to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Analysis of the lead was completed on (b)(6) 2014. A coil break was identified in the positive coil. Scanning electron microscopy images of the positive coil break (2nd portion) show that pitting or electro-etching conditions have occurred at the break location. Also, the coil has what appears to be wear (flat surfaces) in the vicinity of the break. Due to metal dissolution the fracture mechanism at this end cannot be determined. Scanning electron microscopy images of the positive coil broken end located at the third portion (mating to second portion) showed what appears to be wear (flat surfaces) on the coil strands, resulting in reduction of the diameter of the quadfilar coil strands up to the point of break. Other than the above mentioned observations and typical wear and explant related observations, no additional anomalies were identified in the returned lead portions.

Manufacturer Narrative

Manufacturer Narrative
Review of manufacturing history records performed. Review of lead manufacturing history records confirmed all quality tests were passed prior to distribution.

Event Description
Additional information received on (b)(6) 2013 from a nurse who was calling on behalf of the patient's mother who inquired about vns mri precautions with high lead impedance. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received indicating that the patient¿s mother felt that vns was very effective.

Event Description
It was initially reported that the patient's mother was able to feel the patient's stimulation through his right arm and back and that the patient had high impedance on a diagnostic test performed on (b)(6) 2011. At that time the nurse reported that she would discuss disabling the device with the physician. No trauma or manipulation was suspected. Additional information was received indicating that the mother was feeling the stimulation every three minutes. There were also no causal or contributory programming changes prior to the reported event. Diagnostic history provided indicated that the high impedance was first observed on a diagnostic test performed on (b)(6) 2011. The patient's device was disabled; however the physician chose to re-enable it as the patient started experiencing an increase in seizures. The patient has since been referred to a surgeon. Revision is likely but has not occurred to date. No additional information has been made available at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438113


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:30:06 AM
Event Date 06/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a physician's office that the pt was complaining of chest pain, coughing, and pain in her right arm that started approx two weeks prior. The pt had been to the er and the physicians ruled out "other issues" and told the pt that the symptoms "must be the vns. " the pt was at very low settings and could not tolerate any higher programming. The pt swiped her magnet and had significant cough and tightening of her chest. Also, the pt was unable to tolerate the system diagnostic testing parameters to test device function. The device was disabled to see if the issue resolved. Also, the pt is not currently taking any different medications than in the past. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2201826


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:34:48 AM
Model Number 103
Event Date 01/06/2012
Event Type Injury
Event Description
Additional information was received on january 26, 2012 when the explanted lead and generator were returned to the manufacturer for product analysis. The electrode array portion of the lead was not returned for analysis, and therefore, an evaluation and resulting commentary cannot be made on that portion of the lead. Visual examination of the lead identified what appears to be a cut opening and a puncture in the outer silicone tubing. No obvious damage to the inner silicone tubing of the lead coils was noted at these locations. The conditions are consistent with those observed due to the explant process. The lead assembly has remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. The assessment of the believed leakage path was the cuts or punctures made in the lead during the explant procedure. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis on the generator was completed on february 9, 2012. Electrical test results demonstrate that the pulse generator performs according to functional specifications and there are no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
On (b)(6), 2012 additional information was received when the patient further stated that while she was still implanted, she visited the emergency room twice because of burn marks received when using her magnet. The patient stated that both emergency room physicians advised her that she needed the device explanted before she died from it. However clinic notes from the patient's visit from the neurologist on (b)(6), 2012 were obtained which stated the vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The patient said she can't wear her hair down because when it touches her neck she has severe pain. The patient additionally stated that she had traumatic brain injury (tbi) before being implanted and therefore should not have been implanted in the first place.

Manufacturer Narrative

Event Description
On (b)(6) 2012 the vns patient reported that since (b)(6) 2011 she has been experiencing pain in her head that is different from a headache, as well as pain in her right arm and an increase in seizures. The patient stated that the pain usually occurs after she has had a seizure. The patient did not know the relation of her increase in seizures to pre-vns baseline levels. The patient reported to the case manager that she is not currently seeing a neurologist as she has a different insurance now. The patient sated that she is feeling a constant low voltage electrical shock in her brain. The patient taped her magnet over the device and said she experienced a burning feeling from the magnet. She said there was a burn mark on her skin when she removed the magnet. She stated that when the magnet was taped over the device, she did not feel the painful stimulation. The manufacturer's consultant reported that the patient had previously lied about her insurance so finding a neurologist was difficult. They found one the patient could see but the patient's husband refused to drive her there. The patient then showed up at the emergency room where the patient's real insurance information was discovered. The patient was seen by a neurologist and he disabled her device because of her reported pain. He went ahead and referred her to a surgeon because of the pain but she screamed at the neurologist and the staff so he asked her to leave and he will not see her again. The patient stated that she still felt painful stimulation even when the device was off and that the magnet stimulation burned her when she swiped the magnet. The clinic notes from the patient's visit from the neurologist on (b)(6) 2012 were obtained which stated that the patient was tearful and hysterical over the pain due to vns. The patient was angry that vns has not helped her. The pain and burning was reported to have started on (b)(6) 2012. The patient stated that she is currently taking hydrocodone for the pain but asked for more pain medication. The neurologist tried to run diagnostics but the patient would not tolerate it and remained hysterical and belligerent. The vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The manufacturer's consultant reported that the patient had her generator and lead explanted on (b)(6) 2012 due to a device malfunction. The patient's husband did not want the explanted product sent to the manufacturer for product analysis; however the surgeon did want the devices sent to the manufacturer. The husband became verbally abusive and was provided the options of having the manufacturer perform product analysis on the device or have the device sent to him without product analysis if he signed a release form.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434478


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:38:53 AM
Model Number 103
Event Date 01/21/2012
Event Type Injury
Event Description
It was reported on (b)(6) 2012 that a vns patient had not had her device checked in over a year and went to the er the weekend prior to the report due to an increase in seizures. The patient had 10-12 per day when she would usually only have 2-4 per month. The patient was also experiencing some numbness in her right face, hand and arm. The patient also had a burning feeling on the right side of her brain. The patient currently does not have a physician and has not found one who can check her device therefore all attempts for further information cannot be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438386


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:42:09 AM
Model Number 300-30
Event Date 12/02/2011
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2011, were received from case management which revealed that the patient had experienced chest pain for the past (b)(6) months, which radiated down her axilla and arm. The patient has had catamenial seizures affecting her right arm since age fifteen. She has had spells of right arm stiffening two years prior to her first generalized tonic-clonic seizure at age (b)(6). It was reported that vns has "reduced her seizures from daily to only associated with menses. " the patient was seen on (b)(6) 2011, on an urgent basis due to a new onset of headaches that required hospitalization, as well as seizures. The patient's seizures have been variable over the years from five seizures per day, to as many as twenty per day (30% during wakefulness and 70% waking her from her sleep), especially during ovulation and onset of menses. However prior to vns, she had them outside her menses as well. The patient experiences multiple focal seizures around her menses. The patient's chest pain is described as sharp affecting the lateral and posterior region of her left chest. However, palpation does not recreate pain, rather, the pain is created by stretching. The patient takes hydrocodone and ibuprofen for the left chest pain. The patient was concerned that vns may be causing the pain. Further more, the patient called the physician on (b)(6) 2011, as documented in the clinic notes because she was having chest pain and went to a cardiologist who alleged that she has a "broken wire" in her vns. The patient reported that the cardiologist felt around it and stated that he "felt a pulse where it was broken. " the patient reported that the pain was so bad, when she got home that she took a percocet, but the pain still persisted around her heart area, left axilla, and down her left arm to her hand. The patient wanted to know what to do because the pain was progressing. The patient was referred for a stat chest x-ray to check the leads. However, no lead breaks were noticed by the physician during a review of the x-rays. The patient was prescribed percocet. The patient was also referred for a consult with a surgeon for a new generator or vns adjustment. The x-rays were not sent to the manufacturer for analysis. The patient had generator replacement surgery on (b)(6) 2011. Attempts for additional information from the patient's neurologist's office have been unsuccessful thus far. The reason for generator replacement is not known at this time. The diagnostics performed on (b)(6) 2011, did not indicate that there was a device malfunction. A batter life calculation was performed with the history available in the in-house programming database, and the results were approximately 3. 91 years until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2387860


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 03:43:41 AM
Model Number 102
Event Date 06/06/2013
Event Type Injury
Patient Outcome Required Intervention
Event Description
On (b)(6) 2014, it was reported that this vns patient was referred for revision due to pain. Clinic notes dated (b)(6) 2014 stated that no changes were made to patient¿s medications as she was tolerating her medications well. The patient¿s device settings were increased during the visit. The patient presented with increased chest pain during an office visit on (b)(6) 2014. A chest ct was reported by the physician to be unremarkable. The patient¿s device settings were lowered during the office visit. The patient complained of persistent pain in her left chest and her left upper extremities during an office visit on (b)(6) 2014. The patient¿s device was programmed off, and it was noted that the pain was also occurring without stimulation. The patient reported that she was still feeling electricity-like pain in her arm and palm. The patient had previously reported that she began feeling pain in the vns area of the chest along with a headache and slight fever after entering a building and passing through a metal detector in (b)(6) 2013. It was confirmed that the events are occurring continuously as well as with stimulation. She also stated that she has been experiencing voice alteration with stimulation which she did not experience previously. Additionally, she was seizure-free for a while and had one seizure. At that time, diagnostics were normal and the battery was reported to be fine as well. Attempts for additional relevant information were made but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717363


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:27:36 AM
Event Date 01/01/2002
Event Type  Injury   
Patient Outcome  Disability; 
Event Description 
Reporter indicated that pt's left arm is limp following surgery. Investigation to date has been unable to determine the severity of the reported event. Attempts to obtain add'l info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=378704


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:39:32 AM
Event Date 09/18/2002
Event Type Injury
Patient Outcome Disability;
Event Description
Rptr indicated that since generator replacement surgery for end of svc, pt has experienced a tight feeling in the neck, pain on their whole left side and they cannot straighten left arm. The pt reportedly had no problems with their original generator that was implanted in 1996. The pt's lead was not replaced. The replacement generator had not yet been programmed to on at the time of the initial report, but was programmmed to on approximately 2 weeks after replacement surgery. When the physician attempted to program the new device to the same settings that the pt was at before the replacement surgery, the pt had pain in their neck and chest and reportedly still cannot raise their left arm up. The pt's new generator was programmed to the lowest setting (0. 25ma output current) and the pt is reportedly having the same amount of seizures as they did prior to having the vns. Pt is scheduled to be seen again by physician in 10/02.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=424267


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:40:08 AM
Event Date 06/06/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that vns patient has a numbness in the left arm. The numbness is reportedly not painful. Investigation to date has been unable to determine whether the numbess is related to the vns. Patient planned to follow-up with the neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=469319


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:40:55 AM
Event Date 10/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that "she had a muscle twitch in left arm with stimulation. " she said "it keeps her awake at night. " the pt wanted her vns turned off as she could not sleep with it on and was 100 miles from her physician's office. The pt's treating physician believes the pt's insomnia and muscle spasm are related to the vns stimulation and will be programming the pt's vns off per the pt request. Reported "patient lives 100 miles from the nearest location for programming changes and he will just be programming the vns off. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=939865


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:41:21 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that the vns patient was experiencing pain at the chest site, and a tingling sensation beginning at the chest site and propagating down the left arm. Additionally, it was reported that the patient was experiencing a "vibration feeling at the generator site. " diagnostic testing following the onset of the reported events revealed normal device function. The treating physician ordered x-rays to assess the device, and it was reported that the implanting surgeon reviewed the x-rays and "did not see anything out of the ordinary. " further information was communicated by the treating physician's office that the belief is that there is an infection present and has recommended removal of the device. Attempts to obtain additional information from the surgeon and treating physician have been made but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=989370


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:42:04 AM
Event Date 11/27/2007
Event Type Malfunction
Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated a vns pt is to have surgery for lead revision. Pt experienced painful stimulation in the chest, muscle twitching in the chest, and left arm pain. Normal mode diagnostic test performed before surgery was within normal conditions. No sys diagnostic test was performed since pt has not been set to the conditions necessary for the test. X-rays reviewed by the mfr did not identify any anomalies. During revision surgery, normal mode diagnostic test resulted again with normal parameters and lead pin were visualized to be fully inserted. Fluid was seen in the inner tubing of the lead and no cuts or breakages were noticed. A total revision was performed. All adverse events disappeared after new implants. Good faith attempts are being conducted for prod return.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=977110


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:42:28 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that the vns pt was experiencing "tingling sensations" on the "left axilla. " the device was turned off. Reporter indicated that surgery is planned. Good faith attempts are being made to obtain add'l info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=992143


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:43:12 AM
Event Date 03/01/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns depression pt was experiencing left arm, left shoulder, left neck and jaw pain with stimulation of the device. The pt was no longer being followed by the psychiatrist, and was referred to a neurologist to assess the painful stimulation. Further follow up with the neurologist who evaluated the pt, revealed that numerous settings were tried, diagnostics were performed to assess the impedance and battery life, in addition to chest and neck x-rays, and multiple neurological tests, and all came back negative per the neurologist. The neurologist subsequently disabled the vns device and the pain resolved. System diagnostic testing performed prior to disabling the device revealed normal device function. Add'l info was received that surgery was planned to have the device explanted. Surgery subsequently occurred and good faith attempts to obtain the explanted devices have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1518834


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:43:48 AM
Event Date 12/29/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported that the pt was experiencing mild voice alteration with stimulation. It was not believed that a device malfunction was occurring. The painful stimulation that the pt was experiencing was said to "may be due to a massive shoulder operation that the pt had in the near past. " later, it was described that "immediately after the implantation, the pt described a tingling sensation with stimulation. The tingling spread in his left arm and was described as pain with increasing stimulation intensities. The location of stimulation was checked with a plain x-rays, which were not provided to the mfr for review. Subjective and noticeable hoarseness with stimulation was very suggestive of a proper location of the stimulation. The pt did not tolerate the stimulation well and in (b) (6) 2007, experienced pain in the arm with stimulation when 1. 0ma was reached. There was only a quantitative change after reduction of the amplitude or the pulse width during 2008. In the middle of 2009, he noticed involuntary movements of the left arm with each vns-pulse. Therefore, the vns-generator was switched off. On (b) (6) 2010, the vns-stimulator was explanted due to the pain events. At this stage the pt, had clearly visible contractions of the biceps brachii and the deltoid muscle with each stimulation (short test period only). After the operation, he is feeling well again. " the pt was not reimplanted and the device was discarded by the hospital so it would not be returned for product analysis. It is unk if the pt was experiencing a serious injury due to the events or if the device was removed for pt comfort. Review of the programming history available in the mfr's database, showed the last known diagnostics performed were at the time of implant on (b) (6) 2006, which were within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1662336


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:44:29 AM
Event Date 02/04/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns patient experienced pain from the generator site to the left arm while performing movement since the past two months, and felt the generator was moving. No patient trauma was reported and x-rays were taken and reviewed by the manufacturer. The review of the x-rays revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. The lead body was coiled beside the generator in the chest region, and there was no portion of the lead body located behind the generator that could not be visualized. Interventions planned were to replace the patient's generator. Further information was received from a company representative indicating the patient's generator was removed. At the moment, good faith attempts to obtain the patient's generator returned to the manufacturer have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1658139


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:45:02 AM
Event Date 08/01/2000
Event Type Malfunction
Patient Outcome Required Intervention;
Event Description
Pt experiencing significant weight loss since implant. Pt is also experiencing what appears to be dystonia in left arm during stimulation. The physician indicated that the event could be caused by some type of "short circuit" or "stimulation coming directly from the generator case. " the pt's symptoms subsided after the device was turned off (02/2001).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=323605


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:45:42 AM
Event Date 07/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns patient was referred for generator replacement due to an unknown reason. Clinic notes were sent to manufacturer. Review of the notes revealed that at a follow up appointment dated (b)(6) 2009, the patient's "partial motor seizures are uncontrolled". The patient had reported that "his left arm is shaking all the time" and described the event as intermittent. Medication (clonazepam) was added for the seizures. The next patient clinic note was dated (b)(6) 2010 which notes that the "partial motor seizures are under control, even though, he has had fluctuations". There were no changes made to patient's medication or vns settings per the notes. Further follow up with the site revealed that the patient was referred for generator replacement as the patient was having increased jerking spells in (b)(6) 2010. The physician had documents in the patient's chart that the vns device was implanted 7 years ago and there is question of end of service. Good faith attempts to obtain additional information from the physician are underway. A battery life calculation was performed with the data available in house in addition to the data provided in the clinic notes, and the result did not indicate that the device was at or nearing an end of service condition. The patient has subsequently had surgery where the generator was replaced. Good faith attempts to obtain the explanted generator for analysis are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1805133


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:46:26 AM
Event Date 08/05/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the pt's spouse that following the replacement of the pt's pulse generator, he could not move his left arm. The pt was said to have indicated to the surgeon prior to discharge that he was experiencing pain at his left arm and he could not move his left arm. The pt's wife also indicated that the generator reported migrated and was in a different position than his previous generator. There was no known trauma or manipulation to the generator aside from the surgical placement. There was no prescription prescribed at the time of discharge by the surgeon. The treating neurologist later prescribed medication for the pt. The next day, the pt was said to have went to er due to pain in left arm and him not able to move left arm. The er took x-rays and put him into a sling. Good faith attempts to obtain add'l info from the surgeon have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830839


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:46:51 AM
Event Date 01/01/2008
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Initial reporter indicated that after their second implant in 2008 that they had to have another one done. This surgery has not been confirmed to have occurred. The pt reported that their incision failed to heal and they had to go to the emergency department and the doctor healed it. The pt also reported that he got scar tissue built up around the electrodes and a lump at the incision site that was "pinching" the nerve because he had numbness of his left arm. Good faith attempts are being made for additional information about the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1440164


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:47:17 AM
Event Date 02/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt complains of discomfort at the generator site and has had this pain since shortly after implantation. It was reported that pt has limited movement of left arm due to this pain. There are no signs or symptoms of infection. Physician does not believe that the device has migrated or is working inappropriately.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=346994


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:47:43 AM
Event Date 01/15/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Rptr indicated that pt experienced an electric shock while the pt was at work that ran up the pt's left arm. After the shock, the pt experienced several cluster seizures. It was reported that prior to this event, the pt's seizures had been well controlled with the ncp system. Two attempts have been made to obtain add'l info (1 via certified u. S. Mail to physician and 1 via telephone conversation with physician's receptionist) with no response to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=377565


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:48:09 AM
Event Date 03/01/2002
Event Type Injury
Patient Outcome Hospitalization; Disability Required Intervention
Event Description
Reporter indicated that the pt has had several episodes of tachycardia (increase of heart rate to 130's) for which pt they have been evaluated in the emergency room. It was also reported that the pt experienced significant swelling in tile arms. No infection was seen, but antibiotics were administered to prevent infection. Reporter also indicated that the pt is not doing well and the er does not know what to attribute this to. It was later reported that the pt was explanted due to infection, left vocal cord paralysis, and a red and swollen arm. Tests were taken for blood clots on the pt's arm with negative results. It was reported that the pt began having symptoms a few days after implant surgery and that the pt was hospitalized due to infection at implant site and reflex sympathetic dystrophy of left arm. The pt was seen by an infectious disease consultant and three individual otolaryngologists who all indicated that the pt has no infection. The pt's neurologist and a separate infectious disease consultant indicated that they believed the pt has an infection. The pt was hospitalized for 1 1/2 weeks. Further follow-up revealed that the tachycardia has improved slightly and the pt is seeing a cardiologist as an outpatient. Reporting neurologist believes that the tachycardia and bilateral arm edema are related to the vns implant. The vns was never turned on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=388401


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:48:36 AM
Event Date 07/01/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention .
Event Description
Reporter indicated that pt underwent revision surgery on 2002 to reposition the lead coils. The pt's physician decided to perform the revision surgery because the pt was experiencing pain in the left arm in addition to feeling stimulation at the generator site. Programmed parameter adjustment was restricted as a result of the pt's reported symptoms. Additionally, the pt has been unable to reduce or discontinue anti-epileptic medications since the complete range of available device settings were not able to be used due to the reported side effects. Since repositioning the lead, the pt has been very hoarse. It was reported that the pt had a significant amount of scarring where the lead coils were attached to the nerve, requiring a great deal of manipulation to reposition the coils. Evaluation by an ent revealed that the pt's vocal cords looked normal; however, the ent was rpeortedly concerned that the recurrent laryngeal nerve had been damaged. The pt's device has not yet been programmed to on following the revision surgery. The pt's voice is hoarse and reports that speaking is difficult. The pt has reportedly had no improvement in voice since the revision surgery. The pt has reportedly had good seizure control with vns therapy. X-rays taken in december 2000 did not reveal any discontinuities in the ncp system; however, the physician reported that there was a part of the lead that looped down adjacent to the first rib. The physician believed that since that part of the lead appeared to be in the area of the brachial plexus, that the lead may be pinching or depolarizing that nerve. Device diagnostic testing was within normal limits, indicating that the device is functioning as intneded.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414541


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:49:03 AM
Event Date 05/22/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that within a few hours of initiating stimulation, the patient's left arm began twitching. Stimulation was initiated approximately two weeks post-implant. The patient then developed a fever of 104 degrees f. The patient was taken to the emergency room where testing for infection was negative. The specifics of the testing are unknown. The patient's device was programmed to off at office visit on 6/18/2002. Within a few hours, the patient was doing fine again. Investigation to date has been unable to determine whether or not the event is related to the ncp system. Further follow-up with physician revealed that the patient's device was programmed to off per the request of the patient's family due to an increase in comatose-type seizures. Neither the arm twitching nor fever were reported to the patient's physician. Physician was not sure whether the increase in seizures was related to the vns. There have been no medication changes since vns implant. There are no plans to re-program the patient's device to on due to a disagreement between family members regarding the patient's care.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=406391


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:49:28 AM
Event Date 06/01/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt has experienced swelling on the left chest and down their left arm. The pt has been seen by physician several times to have fluid drained from the swollen area. The pt was hospitalized in 2002 and was administered iv antibiotics via pic line. Vns therapy was initiated during the week in 2002 and has helped with the pt's seizure control.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=405950


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:49:56 AM
Event Date 11/28/2002
Event Type Malfunction
Patient Outcome Hospitalization; Disability Required Intervention
Event Description
Reporter indicated that pt went to the emergency room in 2002 because they could not feel their left arm and neck area. The pt's ncp system was programmed to off. It was later reported that the pt experienced stabbing pains at the generator site and that as a result, the generator was programmed to off and later replaced. Following generator replacement surgery, the pt continued to complain of pain at the generator site after awakening from anesthesia. The pt's lead was then also replaced on that same day as the physician believed that the lead may have a crack in the silicone housing despite device diagnostic test results that were within normal limits, indicating that the device was functioning properly. Following lead replacement surgery, the pt is reportedly doing fine with no complaints.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435497


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:50:24 AM
Event Date 01/24/2003
Event Type Injury
Patient Outcome Hospitalization; Disability Required Intervention
Event Description
Pt began coughing up blood the day after implant surgery and was subsequently hospitalized for three days. It was reported that the emergency room personnel believed that the pt ahd a blood clot in their lung. Treating physician reportedly believed that the hemoptysis was related to intubation during implant surgery. Pulmonologist reportedly prescribed tesslon pearls and previcid. Additionally, the pt reported that their device was programmed to on the day of implant surgery but was later programmed to off that same day due to excruciating pain. The device remains off at this time and the pt continues to complain of pain from the eardrum down to the carotid, down to the implant, down their left arm into their hand. This pain reportely makes it difficult for the pt to carry anything heavy in their left hand. The pt also reported that they developed swelling over the generator site that was diagnosed as a seroma by neurosurgeon with no signs of infection. Pt was instructed by neurologist to take their temperature daily to ensure that no infection developed as a result of the fluid accumulation at the implant site. X-rays of implant site were within normal limits and did not reveal any abnormalities in the ncp system. Neurosurgeon has reportedly indicated to the pt that the only other alternative to alleviate their pain would be to explant the device, which the pt does not want to do.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=448568


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:50:53 AM
Event Date 06/06/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that vns patient has a numbness in the left arm. The numbness is reportedly not painful. Investigation to date has been unable to determine whether the numbess is related to the vns. Patient planned to follow-up with the neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=469319


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:51:19 AM
Event Date 04/22/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt has been experiencing chest pain and hyperventilation since adjustment of programmed parameters. The pt also complains of left arm pain from the elbow up and having problems cathing the breath when the device stimulates. Investigation to date has been unable to determine whether the chest pain is cardiac-related. The pt contacted the neurologist who instructed to temporarily stop stimulation by placing the magnet over the device for a couple of hours and to call him back for an appointment if the symptoms subsided during that time. Neurologist planned to bring the pt back in for adjustment of programmed parameters if the symptoms subsided when stimulation was stopped with the magnet.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=464839


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:51:45 AM
Event Date 05/01/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that vns pt had been experiencing arm and facial numbness with burning and pain since approx one or two weeks post-implant. It was reported that the pt had constant numbness on the left side of the face along with daily intermittent burning and pain. The burning and pain is "on and off throughout the day" and lasts approx 4 -5 minutes at a time. The pt also reports left arm numbness, burning and pain which are all intermittent throughout the day. An emg of the pt's upper extremities seems to have ruled-out nerve damage, but the pt is scheduled for an mri of the cervical spine to evaluate for any cervical disk prolapse. Investigation to date has been unable to determine whether or not the pt's symptoms are related to the vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=484514


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:52:14 AM
Event Date 03/09/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt has been experiencing pain to the left breast, tenderness, and tingling and numbness to their left arm, with pain felt up to their neck. It was also reported that the pain is not related to device stimulation. Pt believes that the device has migrated down into their breast and that the device is palpable through the skin. The pt had been trying to lose weight and has lost 60 pounds since initially being implanted. The pt reports that it feels as if the device may have migrated due to the weight loss. The pt experienced chest pressure and pain to their left chest along with numbness and tingling to their left arm; therefore, thought that pt was having a heart attack and went to the hosp emergency room where pt was told that pt has not had a heart attack. The pt has been seizure-free until two months ago and has since experienced a seizure. Their last seizure involved more of their body and pt experienced urinary incontinence with the seizure. The pt also believes that the device magnet stimulation is weaker than it has been in the past. Further follow-up revealed that device diagnostic testing was within normal limits, indicating proper device function. Neruologist indicated that pt's chest pain has resolved. Neurologist does not believe that the pt's device has migrated; however, has reffered the pt for follow-up wtih neurosurgeon for second opinion and possible generator replacement due to the likelihood of the device nearing end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520253


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 07:52:45 AM
Event Date 04/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns pt was experiencing rapid heart beat. The pt also reported pain in the left side of their neck, left arm pain and left leg pain when they initiate magnet mode stimulation. Additionally, the pt reports that they had petit mal seizures. The pt reported these symptoms to their neurologist and scheduled an appointment for follow-up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=524670


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:06:44 AM
Event Date 02/01/2004
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that the pt has been experiencing pain and a burning sensation in the chest, neck and left arm for the past 3-4 weeks. It was also reported that the pt began experiencing continuous blurred vision approximately 2 weeks ago. Further follow-up revealed that the pt's device was programmed to off. Epileptologist indicated that the pt's symptoms and blurred vision resolved after programming the device to off. Epileptologist referred the pt to neurosurgen for possible device explant. Epileptologist would like the pt to be seen for follow-up by a neurophthalmogloist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520134


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:07:22 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Disability;.
Event Description
Reporter indicated that vns pt is experiencing atrophy of the muscles in their left arm along with involuntary muscle spasms. The pt is awaiting an emg (electromyography).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=539112


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:07:56 AM
Event Date 12/01/2003
Event Type Malfunction
Event Description
Pt's generator began protruding approximately 2 months post-implant, causing pain for the pt at the generator site and an inability to move their left arm at times. Revision surgery will likely be performed. It was reported that the device has not extruded through the skin, but that the generator had migrated and was protruding from underneath the skin. The pt reported that the generator was initially located below the level of the chest incision, but that it was now located directly underneath the chest incision, where half of the generator was below the incision and the other half was above the incision.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612080


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:08:22 AM
Event Date 04/15/2004
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that patient was experiencing pain when moving their left arm and that treating neurologist believed that there may have been some kind of traction injury to the brachial plexus or radial nerve during vns implant surgery. The patient was subsequently holding their wrist in a flexed position at the elbow along with a wrist drop. The patient reported pain and swelling in their left hand after vns implant surgery with a marked inability to use their left upper extremity for transferring in and out of a wheelchair. X-rays reviewed by orthopedic surgeon showed some osteoporosis with normal bony alignment and no fractures. Orthopedic surgeon indicated that upon evaluation, the patient had radial nerve palsy with possible brachial nerve injury affecting their ability to extend the wrist and fingers. Orthopedic surgeon recommended neurological evaluation and physical therapy to stretch the wrist and hand and occupational therapy to work on range of motion with appropriate splints for the radial nerve palsy. Treating neurologist indicated that an emg of the patient's left upper extremity was limited due to a fair amount of spasticity in their upper extremities bilaterally, but that there was no clear evidence that the patient has radial nerve palsy. Neurologist has ordered blood tests and a bone scan since the patient is still experiencing pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=542879


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:08:49 AM
Event Date 09/01/2004
Event Type Malfunction
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt underwent revision surgery due to left arm twitching and pain. During the revision surgery, a small tear in the lead insulation was noted. Prior to revision surgery, programmed parameters were reduced in an effort to alleviate the pt's symptoms. The pts seizure control was not as good following the reduction in programmed parameters, so the parameters were increased and the pt's pain was then worse. The pt reported pain in their neck and a visual abdominal switch when they laid down. Revision surgery was performed, during which a piece of silastic was rapped around the vagus nerve and sutured with a 4-0 neurelan suture extending from above the electrode array. The silastic was wrapped once again around the nerve, but not sutured in place again. Then, with a microscope, it was noted that there was a small tear in the lead insulation at the distal portion but that the wires beneath it were intact. The tear in the lead insulation was coated with silicone glue.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612028


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:09:23 AM
Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
When vns patient is talking or laughing a lot, they feel their heart racing and their chest and arm hurt on the left side. The patient reports that when they are talking, they get tired very fast. The patient reports they occasionally experiences chest pain in the area of the device when they are talking. When this pain occurs, the patient begins to lose their voice and lose their breath and they feel their heart rate accelerate. The pain reportedly lasts for approximately 3 minutes and the patient drinks water to regain their voice and breath and takes over the counter pain medications for the pain. Additionally, the patient reports that they feel as though there is less tissue over the device now than when it was first implanted. The patient reported that months ago, their neurologist referred them back to the neurosurgeon due to complaints of pain in the area of the device and that the surgeon indicated that everything was fine at that time. Treating neurologist does not believe that the patient's complaints are related to the vns and indicated that they may psychogenic or related to anxiety. Treating neurologist indicated that the device had not migrated and that there were no signs or symptoms of infection or other problems. The patient currently experiences 1-2 seizures per day, but has not had to go to the hospital emergency room for seizures in some time. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=600068


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:10:04 AM
Event


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:11:15 AM
Event Date 02/01/2005
Event Type Injury
Patient Outcome Life Threatening; .
Event Description
Vns patient has experienced needle-like chest pain during stimulation that radiates from them sternum to left chest and down their left arm along with becoming diaphoretic. The pain reportedly started when the patient began training for long distance marathon racing. The patient participates in a strenuous exercise class that involves much running and sprinting and reportedly becmes symptomatic during stimulation cycles when exerting this much energy. With these symptome, patient ends up stopping and having to kneel down until the symptoms subside. The patient has a history of asthma but was recently cleared by their pulmonologist. The patient has stopped all activity pending consult with a cardiologist. Investigation to date has been unable to determine whether the patient's chest pain is cardiac-related as results of evaluation by cardiologist were not yet available in physician's records.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=621150


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:11:51 AM
Event Date 04/01/2005
Event Type Malfunction
Event Description
The patient underwent revision surgery, at which time it was discovered that the lead electrodes were not attrached to the vagus nerve. Both the lead and generator were replaced. The burning sensation has resolved with the device replacement. The lead assembly was returned to manufacturer for analysis. The reported events of burning or heat sensations are not duplicate in the laboratory environment. Visual examination of the lead assembly identified incisions, punctures in the silicone tubing, and exposed sections of the lead coils; however, it is unknown whether these conditions existed during the implant life. The condition of the returned portion of the lead, in general, is consistent with conditions that typically exist following an explant procedure. The lead pin showed evidence of a proper mechanical and electrical connection as expected. The pulse generator was also returned to manufacturer for analysis. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, ruling out generator battery end of life. Visual examination performed prior to decontamination showed that the septum was cored and contained dried blood in the septum cavity. There were no performance anomalies or any condition found with the pulse generator that would have contributed to the reported events; however, if the septum was cored during the implant life, this may have been a contributing factor to the paresthesia. The likely cause of the patient's symptoms is the fact that the lead electrodes were not attached to the vagus nerve. The reason that the electrodes were not attached has been ascertained.

Event Description
Reporter indicated that when treating, neurologist attempted to increase the device duty cycle, the patient began to note a "burning" or "heat" sensation at the generator site. It was reported that the patient's pain is in the area of her left breast and often radiates into her left arm. This pain has progressively worsened over approximately 7 months time. Device parameters were subsequently decreased to previous settings. Device diagnostic testing performed while the patient was hospitalized was within normal limits, indicating proper device function. The elective replacement indicator was no, ruling out generator battery end of life. X-rays reviewed by treating neurologist did not reveal any obvious discontinuities in the vns therapy system. Stimulation was temporarily discontinued, after which the patient's symptoms reportedly subsided; however, the patient cannot withstand long periods without vns therapy. It was reported that during the half-hour to one-hour cessation of stimulation, the patient deteriorated clinically. Treating surgeon indicated that the patient might be suffering from inflammation at the generator site and suggested treatment with intra-site application of steroids. Treating neurologist did not agree with the surgeon's diagnosis because of the cessation of pain in the absence of stimulation. Neurologist reportedly believes that the generator is dissipating heat and should therefore be replaced. Neurologist does not suspect nerve damage and indicated that the patient did not manipulate the device through the skin. The patient has been referred for surgical consult.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=652946


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:12:42 AM
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected but no report of serious injury or death was received.

Event Description
Reporter indicated that pt was experiencing painful stimulation to the left shoulder, left arm, chest and stomach, and in addition, reported feeling a "loose piece of metal in the generator area". During the investigation, it was noted that the pt only had these complaints after she underwent two surgeries for implantation of bilateral prosthetic breast implants due to previous bilateral mastectomies. X-rays reviewed by mfr showed appearance of the connector block not in parallel alignment with the generator. Last known diagnostics indicated proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=967445


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:13:13 AM
Model Number 102
Event Date 06/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that a pt developed left arm pain and tenderness at the generator site following implantation of a vns therapy system. It was subsequently determined that the pt had an infection. The pt's generator and lead were explanted and the pt was treated with antibiotics.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=884554


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:13:40 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
It was reported that a vns pt was experiencing painful stimulation in the ear and jaw and a pinching sensation in the left arm. Further follow up with the dosing physician revealed that there was no believed cause for the events. X-rays were reviewed by the manufacturer and no obvious anomalies were visualized. A normal mode diagnostic test was performed following the onset of the reported events and the results indicated normal device function. Further follow up revealed that, the pt's generator had migrated and, as a result, the pt was referred for revision surgery. Surgery was performed and it was observed that the generator had migrated toward the left armpit. The surgeon repositioned the generator in the chest pocket and secured it to the fascia. Device diagnostics performed intraoperatively following the repositioning of the generator revealed that the device is functioning within normal limits.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=898853


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:14:06 AM
Event Date 11/01/2006
Event Type Injury
Patient Outcome Other;
Event Description
Initial reporter indicated that their child's generator had migrated and that their child had a "lump on their neck the size of an olive" after a "bad seizure" reportedly, the patient did not resume speaking after this seizure for four days. Reporter also indicated that there is not an increase in seizure activity since vns. The patient's treating physician stated "the vns device moves and causes pain when lift left arm. " in addition, he stated that "the patient feels the generator is moving-i cannot see this clinically" and "she is now hoarse-clinically seems to have superior laryngeal nerve palsy-perhaps nerve injured during a seizure as symptoms started after a prolonged strong seizure. " attempts have been made to obtain device diagnostics to confirm proper device functioning. Good faith attempts have been made and no additional information received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=892209


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:14:31 AM
Event Date 01/01/2007
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a pt was having vns stimulation-related muscle spasms in the left neck, arm, and hand. Parameter changes were attempted to relieve the spasms but were unsuccessful. The patient underwent a right-sided vns system placement. The original vns system was left in the pt and disabled. The patient's symptoms have resolved and the patient is currently receiving right-sided vns stimulation. The original vns system will be utilized if needed in the future.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=875017


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:15:04 AM
Type of device: Cyberonics VNS Pulse Generator
Device brand name: Demipulse
Device manufacturer's name: Cyberonics
Date of this report: (mm/dd/yyyy) 03/08/2011
Describe the event or problem:
Explantation of Cyberonics VNS Demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.

The device(s) may have caused or contributed to: Minor injury to the patient or health care provider

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=71973


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:15:33 AM
Model Number 102R
Event Date 11/22/2007
Event Type Injury
Event Description
It was reported to mfr that the vns patient was experiencing a recent onset of painful stimulation in the left arm and left arm muscle twitching associated with stimulation. Further follow up with the physician revealed that ht patient reports that the painful stimulation may be positional and that the muscle spasms occur more when his head is turned to the left. A system diagnostic test was performed by the physician following the onset of the events, and revealed normal device function. The magnet has been used to temporarily disable stimulation of the device. X-rays were taken and were sent to mfr for review. Review of x-rays revealed that the positive lead connector pin did not appear to be fully inserted inside the generator connector block, which may be contributing to the reported events. No other anomalies were observed upon review of the x-rays. The physician has referred the patient to a surgeon and surgery is likely. Attempts to obtain add'l info from the physician have been made, but have been unsuccessful to date.

Manufacturer Narrative
Chest and neck x-rays were reviewed by mfr. Xrays revealed that the positive connector pin does not appear to be fully inserted in the positive connector block. Conclusions - the lead pin not fully inserted may be contributing to the reported events, but did not cause or contribute to death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968012


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:16:03 AM
Event Date 09/19/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the vns patient began experiencing multiple adverse events which followed an increase in the device settings. The settings were changed from 1. 75m a/30hz/500usec/30sec/1. 8min to 2. 25ma/30hz/500usec/60sec/3min in 7. The patient left the physicians office tolerating the settings. On the way home, the patient began experiencing pain at the generator site during stimulation when the left arm was in a lifted position. Later in the evening, the patient began experiencing muscle twitching under the axilla on the left side with stimulation of the device. The magnet was used to temporarily disable stimulation and the events resolved. The patient was seen by the treating physician the following day and the device was disabled and no diagnostics were performed to assess the functionality of the device. The physician stated that the patients left arm was numb following the events, and the numbness continued while the device was disabled. The physician referred the patient for an mri of the brain to assess for sensory damage. Chest x-rays were taken and sent to manufacturer for review. The connector pin appeared to be fully inserted beyond the connector block and there were no obvious anomalies observed that could have been contributing to the reported events. After further follow up with the physician, it was revealed that the physician believed that "sensory damage" was confirmed after the mri scan but the mri assessment did not indicate any abnormalities. Additionally, the physician attributed all of the events, including the sensory damage, to vns therapy. The patient was scheduled for revision surgery. Prior to surgery, the patient reported to the surgeon that a second opinion was received by a different neurologist, and the patient stated that the physician indicated that "there was spinal damage" and attributed the damage to vns therapy. Attempts to obtain additional information from the second neurologist are underway. During surgery, a system diagnostic test was performed on the device in question and revealed normal function. The chest pocket was opened and the lead pin was verified to be securely connected inside the generator. A second diagnostic test was performed and again revealed normal device function. Per the patients' request prior to surgery, the existing device was removed and a new device was re-implanted. Attempts to obtain the explanted devices are underway, however, the patient has maintained that the "he owns the device". There were no obvious anomalies observed during surgery. The new device was implanted with no complications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=962544


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:16:33 AM
Event Date 01/17/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that the pt had noticed migration of his vns device. Further assessment by the medical professional revealed that the device has indeed migrated "behind the nipple. " additionally, the reporter indicated that the lead "is easily felt and is very tight across the pt's chest area. " it was also reported that it is difficult for the pt to swallow food. The pt is taking analgesia as it is painful for him to move his left arm. In addition, the pt stated that the stimulation seems different. In addition, reporter indicated that the pt was last seen in 2007 and the device diagnostics were ok and the device was "comfortable in pt's chest area. " it was also reported to the manufacturer that the pt had a fall in late that year and "it has been uncomfortable since then. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1000447


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:16:59 AM
Event Date 01/01/2008
Event Type Injury
Event Description
Reporter indicated that pt had their device explanted. The physician indicated that the pt's generator had migrated, and was subsequently causing paresthesia in her left arm. The physician additionally noted that the original placement of her generator was unusual, i. E. Subpectoral muscle, to accommodate the pt's work requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1061300


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:17:28 AM
Event Date 10/01/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was initially reported by the physician that he saw the patient and ran diagnostics which showed everything working within normal limits with the generator not near end of service. Patient was complaining about weakness in her left arm and sporadic stimulation around the generator site. Patient was also having breakthrough seizures. Physician felt that the battery was weaning out and did not have confidence in diagnostics testing. Patient underwent a battery replacement surgery. Good faith attempts to obtain additional information has been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1909635


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:17:57 AM
Event Date 10/11/2010
Event Type Malfunction
Event Description
A neurologist in (b)(6) reported that they had a vns pt who had high lead impedance. Sys diagnostic testing resulted in: output status, limit, lead impedance high, dcdc 7. The pt did not perceive their stimulation and was having pain in their left arm and back. Migration of their generator was additionally reported. Their generator is reported to be more lateral under the skin than before. It is easy to move and no pain on palpation. The pt has 2-4 seizures / month, short and only at nighttime. It was reported that their discomforts are dissociated (more psychosomatic, permanent feeling of itching and scratching on the back, feeling of pain in left arm. Their wound suture was assessed and no irritation noted in the area. It is unk if the pt had any fall or injury, manipulation of their device prior to their high impedance and migration of their generator. X-rays were received and reviewed by the mfr; no pronounced anomalies were identified in the visualized portion of the pt's vns device which could have contributed to the reported high impedance event, although the presence of an unpronounced lead discontinuity cannot be ruled out. Good faith attempts are underway for further details about the reported event. It is unk if surgery is planned at this time. It is unk if the vns is programmed off per our recommendations in the presence of high lead impedance. If surgery is planned, good faith attempts will be made for products to be returned if any replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1893333


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:18:31 AM
Event Date 09/08/2010
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns pt was hospitalized for evaluation of vns generator migration and painful stimulation that was occurring in the pt's left arm and chest at the generator site. The vns was to be disabled. The pt has had no trauma and does not manipulate the vns. Attempts for further information are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1869526


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:19:00 AM
Event Date 06/09/2005
Event Type Injury
Patient Outcome Hospitalization; Disability Required Intervention
Event Description
Reporter indicated that vns pt experienced device migration and neuropathy following generator replacement surgery. It was reported that implanting surgeon was supposed to secure the replacement generator more toward the pt's midline and away from the armpit; however, the replacement generator has reportedly migrated back toward the pt's armpit. Additionally, treating surgeon believes that a nerve might have been damaged during the generator replacement surgery because the pt is now experiencing pain the the arm and loss of mobility of the arm. The pt underwent revision surgery approx 19 weeks after generator replacement surgery to reposition the generator, after which she is reportedly doing well. A steroid injection was administered into the affected nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=644619


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:19:26 AM
Event Date 08/01/2007
Event Type Malfunction
Patient Outcome Other; .
Event Description
The reporter indicated that the pt had a high lead impedance on a system diagnostics test, indicating a possible lead malfunction. The pt reported that during the system diagnostics test, she felt painful stimulation at the generator site and in her left arm. The physician also reported that she has had a seizure increase, equal to pre-vns baseline, for about one week. Revision surgery is planned. A review of x-rays by the manufacturer noted no gross lead discontinuities. Good faith attempts will be made for product return upon explanation of the device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=916949


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:20:06 AM
Model Number 304-20
Event Date 05/31/2012
Event Type Malfunction
Event Description
The explanted lead and generator were returned for evaluation. Analysis is underway but has not been completed to date.

Manufacturer Narrative

Event Description
It was reported that the patient feels pain at the generator site up to the neck area. It was reported that it is unclear whether or not the pain occurs with device stimulation. There has been no falls or trauma that may have caused the pain. Device diagnostics were within normal limits (3337 ohms). Clinic notes dated (b)(6) 2012 note that the patient has some vague complaints of neck pain over his left side, moving down to his left arm and leg. It was noted that the patient describes the pain at sharp in nature and that the patient attributes the pain to vns. Clinic notes dated (b)(6) 2015 note that the patient is having significant discomfort on his left side with vns stimulation. It was noted that the physician believes the generator and lead need to be replaced. The patient underwent generator and lead replacement. The implant card indicated that the generator and lead were replaced due to lead discontinuity and adverse event. No additional relevant information has been received to date.

Event Description
Analysis of the explanted generator was completed on 06/02/2015. 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 06/04/2015. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4723453


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:20:38 AM
Event Date 03/01/2002
Event Type Malfunction
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt heard a "popping' sound and felt an electric jolt run through their body. After the event, the pt could not talk or move and was not able to tell anyone what was wrong, however the pt was fully awake. The pt did not have their magnet with them so the pt was taken by ambulance to the hosp. The pt was later seen by their neurologist who interrogated the device. The pt's device was found to be at the same settings that the pt was last programmed to. Lead test resulted in normal impedance reading (dc-dc code 2 and ok), indicating that the device was functioning properly. The physician programming the pt's device to off in 2002. Further follow-up revealed that the pt claimed to feel stimulation 3 hrs after the device had been programmed to off. The pt reported that this situation was less in intensity than their normal stimulation, but that they had pain in their left arm. The pt reported that since the device has been programmed to off, they had been feeling random mild stimulations but is able to stop them using the magnet. It was later reported that the pt is scheduled to have their lead and possibly their generator replaced due to a suspected break in the lead apparent via x-ray.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=391378


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:22:05 AM
Model Number 102
Event Type Malfunction
Event Description
Reporter indicated that vns pt was scheduled for revision surgery due to device migration. X-rays reviewed by physician revealed that there does not appear to be sufficient slack in the lead wires and that the generator may have migrated towards the pt's back. The pt had previously reported a decrease in seizure activity but was experiencing burning pain, a sensation of shortness of breath and sometmes nausea with stimulation approximately two months prior. The pt's generator was implanted in axillary area but the device was in the normal place, so the pocket is larger than most pts'. Neurosurgeon indicated that it would take the pt longer to heal than most pts due to the fact that he had to go through more muscle and tissue to get the device implanted. The pt reported severe pain and tenderness in left axillary and left upper chest area after washing the car. There was no report of drainage, bruising or signs of infection at that time. Treating neurosurgeon felt at that time that the pt's pain was a result of normal postoperative healing. The pt was seen by treating neurologist approximately two weeks later at which time, lead test had to be interrupted due to excruciating pain in the pt's left arm. X-rays at that time revealed that the device appeared to be intact and that the generator had not moved. The pt reported severe left arm pain approximately every 40 minutes throughout the night on that same day. The pt was seen again by neurologist the next day at which time the device was interrogated and reprogrammed to prescribed parameters. The pt reportedly tolerated the settings well and was no longer experiencing difficulty breathing or nausea with stimulation. Treating neurologist indicated that the aforementioned events had resolved and that the pt was fine. It was later reported that the pt was scheduled for revision surgery due to possible device migration. The original surgery date was cancelled by the pt due to a problem with their children. A new surgery date has not yet been scheduled. Additionally, it was reported that the pt had severe seizure activity the day after vns implant surgery with injuries to the left upper chest after chin/head dropped. Excessive device migration could cause a lead break resulting in loss of therapy. Investigation to date has been unable to determine whether the generator was properly secured during the initial implant procedure or whether the system may have been damaged during the seizure that the pt experienced the day after implant surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481899


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:22:43 AM
Event Date 05/26/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The pt had a post-op neck incision infection. The infection was only topical, was treated, and has resolved. The pt treated the incision infection themselves. It was further reported that the pt has been experiening left arm pain since implant. The pt is now having severe shoulder pain. The pt had a ct scan and it was normal. Neurontin was prescribed. The surgeon believes that the lead electrodes may be too low on the vagus nerve and he is considering revision surgery to move the electrodes. Diagnostic testing was done and resulted in a dcdc code of 1, lead impedance indicating proper device function. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization devices.

Event Description
Further follow-up revealed that the pt again experienced shoulder pain and twitching. The pt indicated that soon after the device was programmed back to on following replacement surgery, they experience shoulder pain, but that they could handle the pain because the vns therapy was helping their seizures. As time passed the pt's shoulder pain and twitching became worse and the pt reported that they experienced two dislocations of their shoulder. The device was then programmed to off to allow the pt's shoulder time to heal. After regaining full muscle strength in their shoulder, the pt's device was programmed back to on and the pt immediately lost 10-15 degrees in motion in their arm. The pt does not want the device programmed off again due to seizure control and is currently weighing their options. The reported event is likely caused by device stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=545510


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:36:33 AM
Event Date 04/25/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a patient had an episode of intermittent esophageal pain that lasted several hours. The generator's normal mode output was disabled, although the magnet output was left programmed. The patient did complain of pain when using the magnet. Diagnostic testing on (b)(6) 2009 showed the device to be properly functioning. Furthermore, the patient's generator was reported to be able to move around in her chest. Follow-up from the patient's physician at the time revealed that the site would not provide any more information on the subjects. However, at a later date it was indicated that the patient had her generator removed due to "pain" in her axilla region, though a migration event could not be confirmed. Additional information from the patient's surgeon's office stated the patient "complained of pain in the axilla and numbness in the left arm from the generator when lying on her left side". Clinic notes from the neurologist indicated that he did not believe the vns was causing left arm numbness. Analysis on the returned generator showed that the septum was not returned, but no evidence of body fluids were observed in the header septum cavity, thus eliminating the possibility of a potential unintended electrical current path through body fluids. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098578


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:37:07 AM
Event Date 05/01/2004
Event Type Malfunction
Event Description
Reporter indicated that the device elective replacement indicator was observed after being implanted for only 17 months, indicating possible premature end of life. The patient had constant pain and shocks in the left arm. The reporter stated that the battery seems to have reached end of life, likely due to "current leakage. " the device was explanted. During the explant procedure, the lead test was within normal limits, indicating proper device function of the lead. The lead was left in place. Neither normal nor premature end of life can be confirmed as the generator was discarded after explant. It was further reported that the arm pain was part of the epileptic syndrome, and not caused by vns. Report is incomplete because attempts to obtain additional information and the explanted device have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=620072


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:37:45 AM
Model Number 102
Event Type Malfunction
Event Description
Vns patient underwent generator replacement surgery due to device migration and left arm pain with paresthesis. The replacement generator was positioned more medially than the original generator was placed. It was reported that the patient's arm strength and pain were better following generator replacement surgery. Investigation has been unable to determine the cause of the reported generator migration. Device diagnostic testing was within normal limits, indicating proper device function and x-rays did not reveal any obvious discontinuities in the vns therapy system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=662265


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:38:11 AM
Event Date 01/01/2005
Event Type Malfunction
Event Description
Device diagnostic testing at office visit resulted in high lead impedance reading, indicating possible device malfunction. The elective replacement indicator was no, indicating that the generator battery had not reached end of life. The patient had recently experienced a violent seizure, during which they fell. The patient reported that they had not felt device stimulation for approximately two months prior to the high lead impedance test result however, device diagnostic testing performed at previous office visit two months prior to high lead impedance test result was within normal limits, indicating proper device function at that time. It is not known whether the seizure and fall occurred before or after this office visit. The patient also reports spasms in both arms for several months, more now in the left arm and especially after seizure. The patient describes the spasms as deep muscle spasms that go up their shoulder and neck. The patient reports that ibuprofen does not help their pain and that their physician want them to take celebrex, but they refused. The patient would like to have the vns therapy system explanted due to the pain in their neck with stimulation. The patient underwent revision surgery approximately seven months prior to the high lead impedance test result, during which a protruding tie down was removed without incident. Device diagnostic testing just after the revision surgery was within normal limits, indicating proper device function at that time. Reference medwatch report 1644487-2004-00927. X-rays reviewed by treating neurologist did not reveal any obvious discontinuities in the vns therapy system. Device settings were increased, after which the patient could still not feel device stimulation. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Lead break is suspected. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612076


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:38:40 AM
Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient has experienced an increase in seizure frequency. The pt has been feeling short of breath, even wtih inactivity and that their left arm occasionally twitches. The pt also reports feeling as if their whole chest is burning and itching. The pt has been seen by treating neurologist on two occasions due to the aforementioned events and that neurologist may have adjusted device settings at these office visits. The pt's neurologist instructed pt to relax and to calm down because pt is anxious.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=608260


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:39:15 AM
Event Date 06/28/2005
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns patient was experiencing left chest arm and neck pain. It was reported that stimulation was initiated at the time of implant. The patient's device was programmed or off with plans to restart stimulation at a later date. Investigation to date has been unable to determine whether the chest pain is cardiac related as no response has been received to manufacturer's requests for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=622610


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:39:44 AM
Event Date 04/23/2011
Event Type Injury
Patient Outcome Required Intervention; .
Event Description
It was reported by a pt that she had undergone a replacement surgery on (b)(6) 2011. A couple of days later she saw her neurologist and her incisions "looked good" and the device was turned on. However, on (b)(6) 2011, she began running a fever and had difficulty raising her left arm, she had a swollen left breast, and had discomfort to the chest area. An er physician stated he believed it to be a skin rash when she was evaluated, but on (b)(6) 2011, she began having drainage from the incision site when she leaned forward. She was prescribed medication for the issues and now reports no further discomfort, very minimal swelling, and mild redness. A review of the generator's design history records showed that it had been sterilized. Further info from the pt stated that she noticed a lump arise on the left side of her neck on (b)(6) 2011. On friday (b)(6) 2011, she was directed to her surgeon and was admitted on (b)(6) 2011. The pt was discharged on (b)(6) 2011 with a course of augmentin. The pt indicated that she had not had an incision in her neck during the replacement surgery on (b)(6) 2011; however, the lump was not decreasing in size and the incision on her left chest no longer has drainage. According to the pt, the surgeon stated the lump on her left neck was not related to the generator replacement surgery. F/u with the pt's neurologist revealed that he wanted all questions directed to the pt's surgeon. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129929


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:40:28 AM
Event Date 07/12/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6), 2011 the vns treating physician's nurse reported that the patient was feeling tightness and radiating left arm pain due to irritation of the nerve by vns so the physician referred the patient for repositioning of the device. She saw the patient on (b)(6), 2011 and the patient reported that the surgeon had repositioned the device on (b)(6), 2011. No further information was provided. If additional information is received it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2251891


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:41:07 AM
Model Number 101
Event Date 08/12/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Patient's device was programmed to off in 2002 following an emergency room visit due to difficulty breathing and chest pain. The patient reported that they felt as if they were having a heart attack. The patient complained of numbness and left arm tingling, but not with stimulation. Device diagnostic testing at that time was within normal limits. In august 2002, the patient reported that they were no longer having any pain or numbness with the device still programmed to off. Physician instructed patient to follow-up with their cardiologist to rule out any heart problems, but it is not known whether or not pt has been seen by cardiologist. The patient's device is still programmed to off at this time. Patient was again seen by neurologist in 10/2002 at which time they reported that pt no longer had any numbness or chest discomfort since the vns was programmed to off and there are no plans to program the vns back to on at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=426771


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:41:36 AM
Model Number 103
Event Date 01/24/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the patient was scheduled for exploratory surgery and possible generator replacement. It was reported that the patient experienced pain (9/10) at the generator site which the patient was seen at the emergency room for. The physician reported that the pain has been occurring for approximately three months and the pain goes from the generator to the patient's shoulder down into the patient's arm which the physician reported is not a normal radicular pattern. It was reported that cardiac issues and pulmonary embolism were ruled out. A ct scan of the chest did not identify any abnormal fluid collections around the generator. It was reported that the patient underwent exploratory surgery with generator replacement due to ifi - yes on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3718781


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:42:29 AM
Model Number 105
Event Date 01/02/2015
Event Type Malfunction
Event Description
The generator was returned for analysis on 05/07/2015, and is in progress. The lead assembly was returned for analysis and was completed on 05/22/2015. The connector ring has what appears to be pitting. Scanning electron microscopy images of the connector ring verified that pitting or electro-etching conditions have occurred on the connector¿s ring surface. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. Note that 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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description
It was reported that the patient started having pain in the left arm and neck that was bad enough for him to go to the emergency room on (b)(6) 2015. The patient¿s vns was then disabled and an x-ray taken to ensure that the lead had not been damaged. Once disabled, the pain initially felt a little better, but the shocking feeling continued after the device was turned off and still had some shocking sensations for the next 24-36 hours. The lead impedance was noted to have shown ¿ok¿ at the patient¿s appointment on (b)(6) 2015 and the patient was turned back on to the lowest possible settings without issue. When asked whether any trauma may have occurred to the lead, the patient admitted to being under the influence of marijuana and that he seemed to ¿loose time¿ and when he came to he was standing in his garage. A copy of the patient¿s x-ray review was received and it was noted that the generator was unable to be disabled with the magnet. The patient later stated that he woke up one day after some seizures and he started to feel really hard stimulations (almost euphorically). Patient said it gave him a good feeling and he was even having conversations with dead people. This went on for 2 days and the hard stimulations were, so overwhelming for him that he went to the emergency room. While he was in the waiting room, he started pushing on his device in his chest and then heard a pop. After that everything went back to normal. System diagnostics were performed on the patient's device again and everything was normal. The patient was referred to a surgeon. The patient reported that he attributes his hallucination and continuous stimulation to the vns. It was noted that the patient¿s device was disabled.

Event Description
Analysis was completed for the pulse generator on 06/10/2015. The septum was not returned and no evidence of body fluids was observed in the header septum cavity. The device output signal was monitored for more than 24 hours, 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. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported that the patient's generator and a portion of the lead were explanted on (b)(6) 2015 due to the patient no longer wanting vns. The explanted devices have not been received to date.

Event Description
It was later reported on (b)(6) 2015 that the patient was referred for explant surgery. Although surgery is likely, it has not occurred to date. The surgeon and the neurologist think that the patient is having mental issues that are causing the patient¿s problems, not the vns device. There have been multiple attempts to send the patient to psychology but the patient will not go. The patient is convinced the device is broken and wants a new one once his beliefs that the device is broken are confirmed, but the neurologist has concerns that this issue will be a recurrent one, as he believes the issue is psychological in nature, and therefore feels an explant is best.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4501232


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:43:13 AM
Model Number 102
Event Date 10/27/2003
Event Type Malfunction
Patient Outcome Disability;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists device (generator and/or lead) migration or extrusion as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns pt underwent revision surgery to reposition the generator due to device migration. The device was moved from the underarm/breast area to the clavicle. It was reported that the pt was experiencing left arm and breast pain and subsequently had limited range of motion with their left arm. The pt was reportedly unable to tape the magnet over the device to temporarily stop stimulation because the device moved around with arm movement. Further follow-up revealed that the pt was diagnosed with possible nerve damage as a result of the revision surgery. The pt has reportedly been referred to a specialist as pt is stlll experiencing arm pain and limited motion in their left arm.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=520742


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:43:37 AM
Model Number 103
Event Date 10/23/2008
Event Type Injury
Event Description
Initial reporter indicated that he was implanted with vns in 2008. He said there is flaking in his neck area. He is not sure if it is dermabond or his skin. He also reports he can't straighten his left arm out like he used to and his neck is sore on the left side. It is unk if the pt not being able to straighten their left arm is a permanent or temporary issue. Reported postoperative so unk if related to normal surgical recovery process. Good faith attempts are being made to attain add'l details about the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1243690


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:44:28 AM
Model Number 102
Event Date 12/02/2011
Event Type Injury
Manufacturer Narrative

Event Description
The physician reported that the patient's reported events, including pain and choking, were unrelated to vns. The physician attributes the patient's complaints to her "psychological issues. " after the device was disabled, the patient's pain and symptoms persisted. The patient also claimed that pain medications did not work either. The physician is referring the patient for explant surgery because the patient complained to administration. The physician originally did not want to remove the patient's vns, but the patient persisted that she wanted it explanted. As such, the patient is being referred for vns explant surgery, but it has not occurred to date. The physician clarified that this is not being done to preclude a serious injury.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the age incorrectly.

Event Description
It was reported that a vns patient wanted her device explanted due to constant pain in the left chest that spreads to the legs and right side of the body. The company representative reported that in clinic notes dated (b)(6) 2011, the patient was complaining of several months of left arm pain, chest pain, and a choking sensation which she attributes to vns. The patient's vns had since been turned off the previous month by neurologist. However, the patient still complained of left chest pain and arm pain. Diagnostics were reportedly not performed because the patient cannot tolerate 1. 0ma. Attempts for additional information have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

Event Description
Product analysis for the generator and lead was completed. The pulse generator diagnostics were as expected for the programmed parameters. The near end of service flag was set, n eos = yes. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. During visual analysis, it was noted that the septum was cored and evidence of body fluid remnants were observed in the header septum cavity. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. There is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaint.

Event Description
It was reported that the patient had her generator and lead explanted on (b)(6) 2012, due to the patient requesting for the device to be removed. No replacement was implanted at this time. The explanted products were received for analysis by the manufacturer, however it has not been completed to date. The return product form indicated that the products were explanted due to the patient wanting it out due to left chest and arm pain.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2488371


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:45:01 AM
Model Number 302-20
Event Date 04/29/2004
Event Type Injury
Patient Outcome Disability,Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist. H. 6. Vns therapy system labeling lists paresthesia, facial paralysis and damage to nerves or vasculature in the surgical area, including the carotid artery and jugular vein as potential adverse events possibly associated with surgery or stimulation. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that vns pt has experienced numbness on the left side of the face and neck area since implant surgery. The pt also feels a "shocking sensation" in the neck area when pt moves their left arm to the left. The pt reports a significant decrease in seizure activity with the vns therapy. It was reported that the pt's incision was more diagonal than the typical horizontal incision and that treating neurologist reportedly believes that the implanting surgeon may have cut some facial nerves causing the numbness. The pt's device was programmed to off, after which the "shocking sensation" resolved. The facial numbness continues after discontinuation of stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=532911


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:45:28 AM
Model Number 101
Event Type Injury
Patient Outcome Required Intervention
Event Description
Reporter indicated that vns patient was scheduled for revision surgery due to device migration. It was reported that the patient has been experiencing sharp pain around the generator site that travels up to the lead electrode site. The patient reports that they cannot tell if the pain coincides with stimulation because they do not feel normal mode device stimulation as they have become accustomed to it, but they do feel this pain when they swipe their device with the magnet. The patient also reports constant pain in their left shoulder which causes them pain when they lift their arm. The patient indicated that the generator was "in a weird location" and was causing their pain. The patient continues to experience significant efficacy with the vns therapy.

Manufacturer Narrative
Ncp system lableling lists device migration and worsening of asthma and bronchitis as potential adverse events possibly associated with surgery or stimulation. Ncp system labeling states that the safety and efficacy of this therapy have not been systemically established for use in patients with history of respiratory diseases or disorders, including dyspnea and asthma

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=544818


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:45:54 AM
Model Number 302-20
Event Date 05/01/2006
Event Type Malfunction
Manufacturer Narrative
B. 3 date of event. This date is estimated; only the year is known.

Event Description
Reporter indicated that device diagnostic testing performed at office viist resulted in high lead impedance reading (dc-dc code 7 and limit), indicating possible device malfunction. The patient was subsequently scheduled for revision surgery due to suspected lead break. It was reported that approximately one week before the high lead impedance condition was discovered, the patient began to feel device stimulation in her left armpit and in the region of her upper left arm. The feelings reportedly coincided with stimulation cycles. The patient had not experienced any recent injury or trauma that may have damaged the vns therapy system. Repeat device diagnostic testing prior to commencement of revision surgery also resulted in high lead impedance reading. During revision surgery, a replacement generator was connected to the original lead, after which diagnostic testing continued to yield high impedance results. The lead was also replaced. Device diagnostic testing of the explanted generator alone was within normal limits, indicating proper device function. It was reported that the pulse generator was replaced prophylactically. Device tracking information submitted to manufacturer for replacement vns therapy system indicates that the explanted system was replaced due to lead discontinuity. No serious injury was report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=730255


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:46:25 AM
Model Number 300-20
Event Date 03/01/2012
Event Type Injury
Patient Outcome Other
Event Description
It was reported on (b)(6) 2012, that a vns patient thought his device was malfunctioning as it was sending electrical impulses to other parts of his body. The patient elaborated by saying he has been experiencing abdominal cramping, chest pain and should pain that was occurring every 5 minutes so he believed it as occurring with stimulation. The patient was also experiencing a shocking pain down his left arm and abdomen. When the patient met with his physician, he described the issues as a sharp pain in the left neck area, and sometimes it affects the left upper extremity, causing it to twitch, almost like a shock. At other times the pain is a funny sensation also in the right upper abdomen going to the right side of the abdomen. This lasts for about 30 seconds and occur every 3-5 days. Overall the pain is not and symptoms are not as severe, but they are still recurring, and strangely they do not occur every rhythmic beat with different time periods in between. The patient has not had any new weakness or numbness. No bowel or bladder changes. No trauma that could explain the symptoms. The patient does not have much of neck pain follow up with the physician revealed that the pain as subsided and the vns settings were lowered. The physician stated that the chest pain, should pain, and abdominal cramping were all related to vns however he did not indicate the relationship. There was no trauma or manipulation prior to the onset of any of the events nor was there any causal or contributory programming or medication changes. The physician will be programming the device off as a result of the reported events. The patient does not have a medical history of chest pain, shoulder pain, or abdominal cramping. When asked if there were any suspected device issues the physician responded "lead break?" however there were no diagnostic results available that indicated a device issue. X-rays were taken and sent to the manufacturer for review however no cause for the patient's adverse events was found. Additionally, no lead break or sharp angles were observed. The patient is going to be referred for revision surgery.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient denies having any pain with the device programmed off and there has not been any seizure activity either. The patient feels that the medications he is taking are controlling the seizures and he did not want to have his vns replaced at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2565708


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:46:54 AM
Model Number 103
Event Date 06/22/2012
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the explanted generator will not be returned for analysis, as the explanting facility requires patient signed release and they will not ask the patient at time of surgery, so therefore, this site will not return to manufacturer.

Event Description
It was reported that the patient's generator had migrated, and she was being referred for surgery. The patient was implanted with vns on (b)(6) 2012. Clinic notes dated (b)(6) 2012 indicated that generator had moved under the axillary region causing pain, pressure in the arm, and discomfort. The pain was indicated to be with movement. It was written that the patient would be referred to the surgeon to evaluate vns placement and make changes as needed. Additional information was received from the neurosurgeon after surgery consult revealing that the patient is experiencing numbness to the left arm due to the generator; moving around; the patient had generator replacement surgery on (b)(6) 2012 due to the generator migration. Attempts for product return have been unsuccessful to date. Attempts for additional information from the treating neurologist and implanting physician have been unsuccessful thus far. Additional information was however received on (b)(6) 2012 from the surgeon that performed the generator replacement which revealed that the migration caused the left arm pain and numbness. It was not believed the numbness was related to stimulation. It was not noted in the operative notes if the explanted generator appeared sutured down during generator replacement. However, it was confirmed that the replacement generator was secured to the pectoral muscle. The migration became symptomatic and quite painful before surgery for the patient which is why the patient had surgery. There was no indication of patient manipulation or trauma. No additional information was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2662284


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:47:27 AM
Model Number 104
Event Date 02/01/2012
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that this vns patient was having trouble with her vns "coming out" from under her skin. This was not the first time this event occurred: one to two years ago, the patient had to have the implant redone because it was not implanted deep enough. (this was previously reported in mfr report # 1644487-2011-00804. ) the patient was reported to be, again, having the same issue. The area appeared infected and was described as red and agitated. The patient was also experiencing pain radiating down her left side and arm. On (b)(6) 2012, it was confirmed that this vns patient underwent full revision surgery. There was also an allegation of device migration. A fax was received from the physician on (b)(6) 2012. The protrusion began two months prior. The patient is implanted with vns and has a local pain which is constant/all the time. The interventions planned included follow up with the implanting surgeon. No causal or contributory programming, medication changes, patient trauma, manipulation, physiological changed (i. E. Weight gain or loss) preceded the onset of the events. The generator was the device protruding. Additional follow up was performed on 07/24/2012 and revealed that no migration was reported. Attempts for product return have been unsuccessful.

Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(4) 2012. The notes indicated that the patient had a history of several different seizure types with complex partial seizures, occasional drop attacks, and rare generalized tonic-clonic events. The patient continued to have one to two seizures per month until the months of (b)(6). At this point, the patient had frequent attacks where she passed out and fell. The patient had not injured herself. In the month of (b)(6), the patient had five seizures. The patient's device was interrogated and changes to the settings were made. A letter from the patient's physician dated (b)(6) 2012, also stated that the patient's seizure frequency was one to two per week, the majority of which were complex partial seizures but also drop attacks. A fax was received on (b)(6) 2012, from the physician; however, no information was provided regarding the increase in seizures. Attempts for product return have been unsuccessful.

Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated the event date was (b)(6) 2012; however, additional information shows that the event date is (b)(6) 2012. This report is being submitted to correct this information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2667386


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:48:15 AM
Model Number 302-20
Event Date 07/16/2012
Event Type Injury
Manufacturer Narrative
Device failure is suspected but did not contribute to a death. Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.

Event Description
Additional information was received from the patient that due to her growing since implant it had contributed or caused the lead to break.

Event Description
On (b)(6), 2012, it was reported that this vns patient was requesting vns explant due to ongoing left-sided pain. The patient was reportedly implanted in 2006 and described an ongoing tightness in her neck and left chest. The use of her left arm was limited due to the pain. The physician described the patient as having a "frozen shoulder" on her left side. The patient was referred for x-rays and explants consult. A battery life calculation on (b)(6) 2012 showed 7. 66 years to eri=yes. Clarification of implant date and attempts for additional information are underway.

Event Description
A physician's letter dated (b)(6) 2012 was received on (b)(6) 2012. The letter indicated that the patient has had relatively good seizure control. The device was unaesthetic to the patient. An eeg was performed but did not show clearly defined epileptiform features in the study. The patient requested that the device be removed. She believed that it was responsible for her left shoulder restricted range of motion. The patient had some tenderness at the long head of the bicipital tendon. The patient's mother believed that the patient had problems with progressive shoulder function associated with having a vagal nerve stimulator put into her left vagus nerve area. This contributed to some social isolation. The patient was scheduled for a battery replacement and repositioning. On (b)(6) 2012, the patient's surgeon reported that the patient had a break in her lead seen during surgery in (b)(6) 2012, so only the generator was explanted. The surgeon questioned whether the lead break was causing the patient pain. The patient was not reimplanted at this time. The explanted generator and portion of the lead was returned on (b)(6) 2013 and is currently undergoing product analysis.

Manufacturer Narrative
Analysis of programming history.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected but did not cause or contribute to a patient death.

Event Description
Clinic notes dated (b)(4) 2013 indicated that the patient presented for suture removal. The left chest wall incision and sutures were intact while the generator was absent. There was no erythema or swelling. Product analysis for the generator showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Lead product analysis showed that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2701479


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:48:59 AM
Model Number 102R
Event Date 07/17/2012
Event Type Injury
Event Description
The patient's explanted products have not been returned for analysis after good faith attempts have been made.

Event Description
It was reported to our consultant that a vns patient will be having a battery replacement to a smaller model. The surgery will be performed because when she shakes her left arm it is irritating her she has numbness and tingling down her left arm. Her neurologist believes the implant is next to brachial plexius and she would benefit from re-position (and a smaller demipulse). The patient will be scheduled for surgery in (b)(6) 2013.

Event Description
Additional information was received that the patient went to surgery. They decided to do a complete revision including a prophylactic battery change. The patient reported pain and the decision was made to replace the generator for a smaller generator. They suspected a lead issue related to her initial complaint of pain (neck) and the pocket was already wide for the bigger generator (ie did not want the demipulse to potentially float in the larger pocket) prior to the surgery the device was interrogated and the results were normal and eos=no. However, the surgeon reported a slit in the lead insulation. It was unknown if the slit was made by the surgeon during the surgery or if it was there prior to the surgery. It is unknown if the lead body will be returned for analysis. At this time the generator is being returned.

Event Description
On (b)(6) 2013, it was reported that, since revision, the pain radiating down the patient¿s arm was no longer occurring.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854766


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:49:31 AM
Model Number 101
Event Date 11/27/2012
Event Type Injury
Event Description
Reporter indicated the patient had vns generator replacement surgery performed on (b)(6) 2013. The explanted generator has been returned and is pending analysis. All attempts to the reporter for additional information regarding the pain event have been unsuccessful to date.

Manufacturer Narrative

Event Description
Reporter indicated on (b)(6) 2012 that a patient was experiencing constant pain in her chest at the vns generator site. The pain was not occurring with vns stimulation. The area is tender to the touch and causes left arm pain to the point that the patient cannot sleep or lay on her side. The patient was seen last by the reporter on (b)(6) 2012, and vns diagnostics results were within normal limits. The patient has been scheduled for prophylactic replacement of the vns generator due to length of implant (>11 years). Attempts for additional information are in progress.

Event Description
Analysis of the vns generator was completed. Proper functionality of the pulse generator and its ability to provide appropriate programmed output currents was verified. The septa do not appear cored and there was no evidence of dried body fluid or corrosion observed in the connector block areas; thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, 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. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

Event Description
Reporter indicated the patient had no trauma, and did not manipulate the vns. The pain was attributed to the "vns battery dying". The patient was "tapering herself off" of vns with vns setting changes. The generator was replaced as an intervention for the pain, and for the patient's comfort and not to preclude a serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887407


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:49:58 AM
Model Number 304-20
Event Date 12/03/2012
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative

Event Description
On (b)(6) 2012 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2012 indicated that the patient has been having hoarseness and difficulty swallowing since the recent full revision surgery. The patient has clear dysphonia and increased weakness of the left arm. The physician reprogrammed the device at 0. 25ma and 0ma which did not change anything. The physician stated that he thinks this is just a postsurgical disturbance of the vagal nerve. They decided to turn the vns for two weeks and then have the vns turned back on in the hope that there will be some healing going on. The physician reported that the patient has damage to her vagal nerve and is experiencing vocal cord paralysis. Previously it had been reported that the patient was experiencing an increased coughing with stimulation after recent full revision surgery on (b)(6) 2012. Additional information was requested from the physician but the only further information he would provide was that he has still not seen the patient since the (b)(6) 2012 visit and that he did not believe she had seen an ear, nose, and throat (ent) physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2904573


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:50:33 AM
Model Number 101
Event Date 07/21/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt was experiencing chattering in her teeth, left arm going up and down, whole body muscle spasms, and harshness with muscles in her throat with magnet mode stimulation. The pt was hospitalized and reported that she was overdosed on dilantin. Disabling the vns device with the magnet did not resolve the teeth chattering event. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1131063


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:51:13 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
Additional information was received that product analysis was completed on the generator and lead. Note that since a portion 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 portion. In the pa lab, 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. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. There was no dried body fluids or corrosion identified in the lead cavity or connector block area, thus eliminating the possibility of a potential unintended electrical current path through body fluids.

Event Description
Further follow-up revealed that the physician does not believe that the pain the patient was experiencing was related to vns therapy or stimulation. The patient underwent generator replacement surgery on (b)(6) 2013. Attempts to have the device returned to manufacturer for analysis are underway; however, the device has not been received to date.

Event Description
The explanted generator and lead were returned on (b)(6) 2013 and are pending product analysis.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(4) 2013 indicate that the patient has been experiencing intermittent pain in the left shoulder and neck region and that it has progressed. It was noted that the pain is more frequent and more intense and that it appears to occur with vns therapy stimulation. Additionally, it was noted that the patient now involves the patient's left arm from elbow to shoulder, the patient's left breast and the left neck and ear region. The notes indicate that x-rays of the chest and neck were performed at the patient's last visit; however, no problems with the "patency of the device or wire" were noted and it was noted that the discomfort the patient was feeling was due to scar tissue. It was noted that the device diagnostics were "normal" and that the device was programmed off. The notes indicate that the patient returned approximately two hours later with a significant decrease in pain. The physician noted that the device would be left off and that the patient would be referred for lead replacement surgery as the physician noted that there may be a short in the wire. The patient has been referred for surgery; however, the surgery has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3010765


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 08:51:45 AM
Model Number 300-20
Event Date 12/03/2001
Event Type Malfunction
Event Description
Reporter indicated that at a follow up visit during the week in 2002, the patient's physician ordered x-rays to check the connection of the lead since the patient does not display any side effects of stimulation and has reported continued lack of benefit from the vns implant. It was reported that the x-ray suggests that one part of the connection to the nerve is "disconnected" but that the x-ray was inconclusive. The physician increased the programmed parameters and as the device was tested with the magnet the patient went into a seizure during magnet mode stimulation. It was reported that the patient continues to have seizures in which their left side completely goes numb, rendering the patient helpless and severely limiting the patient and the patient's parents' activities. It was reported that this is a relatively new phenomena (past year) and that the patient has had two or three bad episodes of this since the stimulator was activated (12/2001). It was reported that the physician planned only to observe the patient over the next three months. It is suspected that user error may have caused or contributed to a lead discontinuity, improper lead placement on the nerve, or improper lead connection to the generator, resulting in lack of therapy for the patient.

Manufacturer Narrative
Reporter indicated that during the revision surgery on 3/27/2002 it was verified that the lead was nowhere near the nerve. It was also reported that no tie downs were used in the initial implant. The neurosurgeon was going to reattach the lead to the nerve but during the surgery he noticed that the lead was damaged. The initial lead was explanted and a new lead was re-implanted. Lead test at re-implant surgery resulted in an ok impedance.

Manufacturer Narrative
Physician indicated that the pt's lead was not placed correctly on the nerves. Pt's parent reported that the pt is scheduled to have revisional surgery performed on his neck to properly connect the wire to the nerve on 3/27/02.

Manufacturer Narrative
Device programming history was reviewed. X-rays were reviewed. Manufacturing records were reviewed. Review of device programming history did not reveal any anomalies or abnormalities. X-ray review revealed that the electrodes and adjacent lead appear to be in a non-recommended routing. No tie-downs are present. The electrodes do not appear to be properly aligned (not parallel). The lead appears to be fully intact; however, the electrodes appear to be low on the nerve if on the nerve at all. Review of manufacturing records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=379476


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:22:47 AM
Model Number 101
Event Date 01/15/2002
Event Type Injury
Patient Outcome Life Threatening
Manufacturer Narrative
Device mfg records were reviewed. Review of device mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Rptr indicated that pt experienced an electric shock while the pt was at work that ran up the pt's left arm. After the shock, the pt experienced several cluster seizures. It was reported that prior to this event, the pt's seizures had been well controlled with the ncp system. Two attempts have been made to obtain add'l info (1 via certified u. S. Mail to physician and 1 via telephone conversation with physician's receptionist) with no response to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=377565


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:23:17 AM
Model Number 103
Event Date 01/13/2010
Event Type Injury
Patient Outcome Other
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient was having breakthrough seizures and now feels tired all the time. The patient reported that the generator was put in arm pit, a pointy thing sticking out of the armpit that she had to get used to. The patient wasn't sure if the surgery caused nerve damage for she had a problem with her arm for 1 year post operatively and could not move her arm. Surgery is likely but has not taken place.

Event Description
Clinic notes dated (b)(6) 2013 indicated that the patient suffered from seizures, headaches, and hemiparesis. Clinic notes dated (b)(6) 0213 indicated that the patient experienced increased back pain and that her hips were still sore because of injections. Clinic notes dated (b)(6) 2013 indicates that the patient had increased back pain with a possible event in her hips. The patient had to use her magnet over the last few days. Additional information was received indications that provided recent diagnostics results. The patient was referred for generator replacement. Surgery is likely but has not taken place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3106886


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:23:47 AM
Model Number 102R
Event Date 07/01/2011
Event Type Injury
Manufacturer Narrative
Date updated based on additional information received from physician.

Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this patient was to undergo explant due to persistent left arm pain. The patient had been seizure free for two years but requested explant. The patient underwent explanted on (b)(6) 2013. The explanted devices are not expected for return.

Event Description
Follow up with the physician found that the pain was first observed two years prior. It was reported that the patient lost weight and the vns was removed. The movement of the patient's arms caused the pain. The pain was not associated with stimulation. No causal or contributory programming or medication changes preceded the onset of the pain.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3265062


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:24:20 AM
Model Number 103
Event Date 01/01/2013
Event Type Injury
Patient Outcome Required Intervention
Event Description
Clinic notes dated (b)(6) 2013 indicated that this vns patient had been experiencing an increase in seizures for the past six months. The patient was last seen on (b)(6) 2013. The patient went to the emergency room on (b)(6) 2013 after having eight seizures in a one to two hour period. The patient experienced clusters of seizures at least two times per week. The patient stiffen, raises the left arm, clenches both fists, drools, lowers his head, turns his head to the left, and stares. The events last 8-10 minutes. The patient could have one event but also could cluster. The patient admitted to being non-compliant with medications and has problems with medication. The patient¿s seizure history included complex partial seizures 2-3 times per day lasting 3-4 minutes. Because of the clusters, the patient¿s vns was checked, and the device was found to be at near end of service, and the patient was referred for generator revision. The patient¿s family did not use the magnet to abort seizures. Surgery is likely but has not taken place.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3274398


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:24:44 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Patient Outcome Required Intervention,Hospitalization
Event Description
It was reported that the patient was complaining of erratic stimulation and pain in the left arm that were making it difficult to breathe. The physician advised the patient to disable the device temporarily and to either have the generator replaced or explanted. The physician informed the patient that the device battery could be wearing down and causing the erratic stimulation. The patient chose generator replacement and was referred for surgery. It was later reported that the patient was hospitalized for pneumonia and that the generator replacement surgery had been cancelled and not yet rescheduled. Surgery is still planned; however, has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3330760


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:25:36 AM
Model Number 103
Event Date 11/01/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013, indicate the patient experienced a worsening of seizures and change in seizures. The notes also state the patient has drop seizures, with left arm out. Diagnostics showed the ifi (intensified follow-up indicator) flag and indicate the lead is ok. Replacement surgery is likely, but has not occurred to date. Follow up with the physician found that both the increase in seizures and change in seizure pattern were first observed in (b)(6) 2013. The change in seizure pattern is believed to be anxiety related and the vns battery is believed to be related to low output from the vns battery based on the ifi flag. It was unknown what the relationship of the increased seizures were to pre-vns baseline levels. All of the patient's seizure types have increased. No causal or contributory programming or medication changes were attributed to the increase in seizures, though it is unknown if they contributed to the change in seizure pattern. Replacement surgery is likely, but has not occurred to date. No other information was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3595749


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:26:08 AM
Model Number 103
Event Date 11/01/2013
Event Type Injury
Event Description
An implant card was received indicating that the patient underwent generator implant on (b)(6) 2014. The lead impedance was marked ok (2592 ohms).

Event Description
Additional information was received stating that the vns patient was experiencing pain and swelling in the generator pocket up to the her clavicle. The pain and swelling began two weeks following replacement surgery and two days after the device was programmed on. The patient¿s pain and swelling progressed for over a month. The patient was unable to feel any stimulation 24 hours after the device was programmed on. The patient reported that no manipulation or trauma had occurred.

Manufacturer Narrative

Event Description
It was reported by the neurosurgeon that the vns patient¿s generator was programmed on by the neurologist a couple weeks after her generator replacement surgery on (b)(6) 2013. The patient reported feeling stimulation and experienced some voice hoarseness with stimulation for about a day. Subsequently, the patient reported that she no longer felt any stimulation (including magnet activated stimulation) or any voice hoarseness. Additionally, the patient was having pain and swelling from generator site down her left arm. The patient¿s generator was explanted due to pain on (b)(6) 2014 and no replacement is planned at this time. The surgeon did not see any sign of infection except for small amount of swelling. No fluid or redness was observed. The explanted generator was returned to the manufacturer on (b)(6) 2014 and analysis was completed on (b)(6) 2014. Monitoring of the device output signal 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. In addition, 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. Attempts for additional information have been made, but no further details have been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3656770


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:26:36 AM
Model Number 102
Event Date 06/06/2013
Event Type Injury
Patient Outcome Required Intervention
Event Description
On (b)(6) 2014, it was reported that this vns patient was referred for revision due to pain. Clinic notes dated (b)(6) 2014 stated that no changes were made to patient¿s medications as she was tolerating her medications well. The patient¿s device settings were increased during the visit. The patient presented with increased chest pain during an office visit on (b)(6) 2014. A chest ct was reported by the physician to be unremarkable. The patient¿s device settings were lowered during the office visit. The patient complained of persistent pain in her left chest and her left upper extremities during an office visit on (b)(6) 2014. The patient¿s device was programmed off, and it was noted that the pain was also occurring without stimulation. The patient reported that she was still feeling electricity-like pain in her arm and palm. The patient had previously reported that she began feeling pain in the vns area of the chest along with a headache and slight fever after entering a building and passing through a metal detector in (b)(6) 2013. It was confirmed that the events are occurring continuously as well as with stimulation. She also stated that she has been experiencing voice alteration with stimulation which she did not experience previously. Additionally, she was seizure-free for a while and had one seizure. At that time, diagnostics were normal and the battery was reported to be fine as well. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717363


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:27:04 AM
Model Number 105
Event Date 04/07/2014
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received indicating that the patient underwent generator repositioning on (b)(6) 2014. No additional relevant information has been received to date.

Event Description
It was reported that the patient is having "a great deal" of pain at the generator site. The patient has a hard time lifting her left arm due to the pain which is reported to be constant and not associated with device stimulation. It was reported that surgery is being considered to either reposition the device or implant a smaller generator model. Clinic notes dated (b)(6) 2014 made no mention of pain at the generator site or plans for surgery. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3787981


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:27:33 AM
Model Number 303-20
Event Date 05/09/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the vns patient would at times experience numbness under her chin and hot flushes in her left arm after her device was programmed on during an office visit on (b)(6) 2014. The patient¿s device showed lead impedance within normal limits (impedance value ¿ 2304 ohms) at the time. The patient was seen on (b)(6) 2014 and reported having some pain in her left arm after her device settings were increased. The patient¿s device showed increased lead impedance but still within normal limits (impedance value ¿ 4649, 4622 and 4701 ohms). X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in an abnormal arrangement as they do not align with the spine but rather perpendicular to the spine. 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 reported events may be due to the abnormal placement of the electrodes. However, no definitive conclusions can be made. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized but identified abnormal placement of electrodes.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899453


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:28:04 AM
Model Number 103
Event Date 07/08/2014
Event Type Injury
Event Description
Additional information was received via implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to the painful stimulation. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description
Additional information was received that the patient's painful stimulation and tingling began reoccurring in the neck and chest on (b)(6) 2015 despite no abnormal or strenuous activity by the patient. The vns device was interrogated and two diagnostic tests were performed which showed normal results. The generator was disabled. At first, the patient stated that she still felt stimulation, but after she was told that the device was off, then she said she couldn¿t feel it anymore. The patient's neurologist says that it could be psychosomatic symptoms. X-rays were taken but the radiologist stated there was no change from the previous x-rays in (b)(6). The device was thus temporarily disabled with magnet mode left enabled. Clinic notes were received from the appointment which confirmed the allegation that the patient was having pain in her left neck and left chest and that the device was disabled. It was also stated that these patient adverse events are similar to the pain event reported in mfr. Report # 1644487-2011-02585. Additional clinic notes stated that diagnostics were taken again and were within normal limits. The diagnostic tests reportedly caused significant discomfort immediately and resolved as the device turned off. The referring physician suspected that perhaps there is conduction of stimulation to surrounding tissues. No known surgical interventions have occurred to date.

Event Description
It was reported that the vns patient was having some breakthrough myoclonic seizures while previously being seizure free. The patient was also experiencing a tingling sensation but was unable to feel magnet mode stimulation when she swiped her magnet. The patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device settings were increased, but the patient reportedly did not feel stimulation in the same way as before and began having pain in her left arm with stimulation. The neurologist decreased the patient¿s device settings and the patient was reported to be doing well. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block; however, this could not be confirmed as the pin was not clearly shown to pass all the way through the connector block. 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 reported events remains unknown. No known surgical interventions have occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3970627


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:28:44 AM
Model Number 102
Event Date 05/23/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the recently implanted vns patient was having pain at her generator incision site and was unable to use her left arm. The patient¿s neck incision site looked great, but the generator incision site was swollen. The patient¿s physicians stated that the swelling at the time was normal. Follow-up revealed that the patient¿s neck incision scar was swollen and tender. The patient had developed an infection at her incision sites and underwent surgery. The details of the surgery are unknown. The patient was given high doses of antibiotics and stated that she was doing great. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

Event Description
On (b)(6) 2014 it was reported that the patient was scheduled for re-implant surgery. The patient underwent re-implant surgery on (b)(6) 2014.

Event Description
On (b)(6) 2014 it was reported that the patient¿s device was explanted due to the infection on (b)(6) 2014. It was reported that the physician will re-implant the patient as soon as she is off her antibiotics and has been cleared by infectious disease.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3963391


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:29:16 AM
Model Number 102
Event Date 05/01/2014
Event Type Injury
Event Description
Additional information was received from the treating physician. He reported that the patient had reached decent settings and requested that his devices get turned off as it was felt to not be helping. The physician reported that the patient was a non-responder. Then, after aed polytherapy failed to improve his seizure control, the physician suggested to turn on his device as it has no role when not active. Once the patient agreed, he displayed a high sensitivity to very low initial stimulations and responded with coughing immediately upon an adjustment that he could not tolerate. Thus, this precipitated the patient¿s requests for a vns removal. The physician reported that this may have represented a psychological response and lack of motivation, but that it was speculative.

Event Description
It was reported on (b)(6) 2014 that the patient reported pain near the generator that persisted mildly even when the device was off for several months. The patient did not believe it improved his seizures, although the surgeon¿s nurse indicated that it may have after it was initially implanted. The patient¿s device was explanted on (b)(6) 2014. The explanted device could not be returned for product analysis as the hospital does not return. Good faith attempts for further information were unsuccessful. It had been reported on (b)(6) 2014 that the patient was on low settings, output=0. 25ma, and felt a pressure in the chest and tingling in the left arm. The physician didn¿t know if the issues were related to the vns.

Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: the initial report inadvertently did not report this outcome, as explant occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4191919


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:29:42 AM
Model Number 103
Event Date 02/07/2014
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2014, note that the patient has been experiencing an increase in seizure activity over the past month. It was noted that the generator should be replaced since the battery is approaching end of service. It was noted that the patient has been experiencing multiple seizures per day (2-3 per day in may, convulsive, 3 mins). Medication changes were made as intervention on (b)(6) 2014. The patient was seen in the emergency room and was observed overnight due to seizure activity that resulted in a fall and laceration. These seizures were described to be sudden stiffening and flexing up to the left arm. It was noted that the patient experienced multiple seizures per day. It was noted that the medication the patient was prescribed in may helped to reduce the seizure, but that the seizure activity returned when the prescription was finished. Clinic notes dated (b)(6) 2014, note that the patient has been experiencing an increase in seizure activity over the past 3 months. It was noted that the generator was interrogated and was not a end of service. Clinic notes dated (b)(6) 2014, note that the patient would return in 3 months for follow-up since the vns is approaching low battery. The patient was referred for generator replacement. No known surgical intervention has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4164233


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:30:05 AM
Model Number 302-20
Event Date 10/16/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s pain was not related to vns and not occurring with stimulation.

Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance. The patient¿s device was subsequently disabled. It was noted that the patient has had pain at her left-sided underarm for approximately two years. It is unknown if the pain was related to vns as the patient had several surgeries for other medical conditions. An implant card was received indicating that the patient underwent generator and lead replacement surgery (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Attempts for additional relevant information will be made.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4251812


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:31:37 AM
Model Number 102
Event Date 01/14/2009
Event Type Injury
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. X-rays reviewed by the manufacturer, migration of the generator was not able to be confirmed on the x-ray views received.

Event Description
It was reported to manufacturer that the treating vns physician saw the vns pt due to swelling in the left armpit and possible generator migration. X-rays were sent to manufacturer to review, and the migration event could not be confirmed as there were no baseline x-rays to compare them to. Diagnostic tests were performed following the onset of the reported event and revealed normal device function. Approximately a week later, the swelling appeared to be improving. Further info received revealed that the treating physician saw the pt again at a later date due to the continuation of the migration of the generator, which the pt believed was causing painful stimulation. Additionally, it was reported that the pt was experiencing an increase in seizure activity. The physician discussed with the pt, the possibility of surgical intervention. The pt then reported that she was seen by the primary care physician and stated that an infection was present, and that the swelling has gotten worse had moved down the left arm. The pt reported that antibiotics were prescribed. Additional info received from the treating vns physician's office revealed that the pt went to an emergency room and was treated with antibiotics and was subsequently released. The fever had resolved, and the swelling was improving. The vns device was disabled and they are continuing to monitor the pt. Good faith attempts to obtain additional info have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341924


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:32:26 AM
Model Number 105
Event Date 11/19/2014
Event Type Injury
Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently stated that the incorrect explant date of (b)(6). Corrected to (b)(6).

Event Description
Product analysis for the lead was completed and approved on (b)(6) 2015. Analysis showed that other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Product analysis for the generator was completed and approved on (b)(6) 2015. In the product analysis lab, 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The final electrical test showed an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the vns patient was having of issues with his left arm and wrist and wanted his device repositioned. The patient noted feeling an electrical sensation at the generator site. Clinic notes were received indicating that the patient¿s generator was protruding and causing pain. Follow-up revealed that surgery was being performed for patient comfort. The patient¿s protrusion and pain were attributed to the initial placement of the device. The patient underwent surgery on (b)(6) 2014. The impedance value (3389 ohms) was within normal limits but the surgeon felt the value was too high. During the procedure, the patient also reported having cardiac pain. The surgeon was concerned that the lead may have not been implanted on the correct nerve, so a both the generator and lead were replaced at the time. The explanted devices have not been returned to date.

Event Description
The lead and generator were explanted (b)(6) 2014. The explanted generator and lead were received for analysis on 12/29/2014. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4343622


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:33:12 AM
Model Number 102
Event Date 01/23/2008
Event Type Injury
Event Description
It was reported that a vns pt had experienced an increase in seizures, which coincided with staphylococcus infection under her left arm, the event was resolved with medication, and that prior to the event there had been no medication changes. F/u with the pt's treating vns therapy physician revealed that the event was related to the pt's revision surgery, and indicated that prior to the infections development there had been no admissions of pt trauma or manipulation. The physician also indicated that the infection was believed to have exacerbated the pt's seizure condition.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1333226


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:33:41 AM
Model Number 304-20
Event Date 12/01/2014
Event Type Injury
Event Description
It was reported that the patient had his vns removed due to the vns electrode breaking through the skin on his left shoulder and subsequent infection. The physician reported that it was interesting that he noticed several weeks prior that the patient was not using his left arm and they could not figure out why, but orthopaedics found no issues with his shoulder. The generator and lead were explanted on (b)(6) 2015 due to infection at both devices sites. It was unknown if there were any external factors that may have contributed to the events.

Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the manufacturer device history records confirmed sterilization was performed for both the generator and lead prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4504658


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:34:23 AM
Model Number 102
Device Problem Material Protrusion
Event Date 11/17/2014
Event Type Injury
Event Description
Additional information was received that the patient underwent generator replacement on (b)(6) 2015. The explanted generator and lead were received on (b)(6) 2015. During the visual analysis what appeared to be a metal staple was observed on the outer silicone tubing. The outer and inner silicone tubes and quadfilar coils appeared to be compressed, in this area. The staple appeared to be from the explant procedure, as the available generator programming history reveals good diagnostic test results. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure and no obvious anomalies were noted. The pulse generator diagnostics were as expected for the programmed parameters. During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative

Event Description
It was reported that the patient experienced muscle spasm in the left arm/elbow during vns stimulation. Diagnostic test results were within normal limits. The x-ray results were also normal. It was later reported that patient has being performing physical activity such as splitting and carrying wood and has also gotten into an altercation that might have affected the generator. The patient also reported to manipulating the lead and finds that it improves his symptoms. The patient has also lost 185 lbs and the vns lead is protruding a little due to patient¿s weight loss. The physician was able to isolate the issue to vns stimulation as the muscle spasms stopped when vns was disabled. The arm jerking was reported to be occurring every 3 minutes with vns stimulation. The patient was referred for generator replacement but no known surgical interventions have occurred to date.

Event Description
Additional clinic notes dated (b)(6) 2015 was received indicating that the patient's vns settings were reprogrammed due to patient's complaint of arm jerks. The patient tolerated the changes well and stated that he felt much better and arm jerks have stopped with the changes in settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623372


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:35:05 AM
Model Number 102
Event Date 01/17/2013
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital in late (b)(6) 2013 for numbness and tingling in the left arm and hand. X-rays were taken and it was reported that this may have been a side effect of either seizures or vns. It was reported that device diagnostics were within normal limits. The device was programmed off and the symptoms subsided. The device was programmed back on and the patient was discharged. The patient was seen again in (b)(6) 2013 and the device was said to be functioning as intended. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4573216


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:35:39 AM
Model Number 102
Event Date 09/10/2002
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient had been having difficulty raising his left arm since being implanted with the device. It was noted that the patient was not experiencing any pain or discomfort from the device. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4871267


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:36:18 AM
Model Number 103
Event Date 06/24/2015
Event Type Injury
Event Description
It was reported that the vns patient¿s device was disabled for mri on (b)(6) 2015. After the mri, the physician attempted to interrogate the patient¿s device, but the patient reported experiencing erratic stimulation from her device when the programming wand was placed near the generator. The patient¿s device was interrogated and found still programmed off. The patient did not experience any erratic stimulation prior to device disablement. The physician programmed the patient¿s device back on to previous settings. The patient also reported having chocking sensations and pain and numbness in her left arm associated with stimulation on-times. It was noted that the patient was mentally delayed, but the physician stated that the patient¿s symptoms did not appear to be psychological. On (b)(6) 2015, the patient returned to the clinic and the patient¿s device magnet mode was disabled. The patient continued to experience erratic stimulation from her device. The patient went to the emergency room on (b)(6) 2015. The patient¿s device was disabled and the issues resolved. X-rays were taken and were reported by the physician to be unremarkable. The patient was evaluated by the surgeon on (b)(6) 2015. The patient¿s device was programmed on and tolerated the programming session well. The patient device was tested and showed normal device function. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4940403


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:37:01 AM
Event Date 10/21/2013
Event Type Injury
Event Description
An implant card was received indicating that the patient underwent lead replacement for "controle lead". It was reported that the patient was experiencing spastic movements of the left arm. No high impedance was observed and x-rays were within normal limits. It was reported that the lead replacement was requested by the patient and that no issues were observed on the lead. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3525968


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:37:31 AM
Model Number 302-20
Event Date 07/04/2006
Event Type Malfunction
Event Description
Reporter indicated a vns pt experienced painful stimulation at the generator site along with muscle spasms in the left arm. X-rays were reviewed which did not identify any obvious lead discontinuities, but a sharp angle was noted in the lead near the lead/pin generator header interface. The pt underwent vns generator replacement surgery and the symptoms resolved. As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the pt's device. This file was found to be possibly related to a short-circuit condition.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mr, no gross lead discontinuities visualized. Conclusion code: device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1476490


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:38:13 AM
Model Number 102
Event Date 02/18/2008
Event Type Injury
Event Description
Reporter indicated that a vns patient's generator had migrated, and the patient was experiencing a "tingling sensation" under her left arm. No trauma or patient manipulation was reported. The patient had lost a lot of weight. Generator pocket revision surgery is planned. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1031591


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:38:54 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 07/21/2015
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Event description; corrected data: the previously submitted mdr inadvertently did not specify the pain associated with stimulation in the patient¿s neck and left arm.

Event Description
It was reported that the patient experienced pain associated with stimulation in her neck and left arm. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description
It was reported that the vns patient was experiencing painful, erratic stimulation from her device. Clinic notes were received indicating that the patient's device showed normal device function and an ifi condition during an office with on (b)(6) 2015. The patient presented with a sore throat which involved occasional pain in the throat from stimulation on-times. The physician attributed the issues to the device nearing end of service and referred the patient for surgery. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5006390


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:39:23 AM
Model Number 103
Event Date 03/19/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:39:55 AM
Model Number 103
Event Date 04/13/2012
Event Type Injury
Event Description
It was reported that the patient experienced choking, increased blood pressure, increased heart rate and voice alteration with stimulation. Patient had gone to the er due to chest pain suspecting a heart issue but was told that the heart was fine. At the er it was found that patient's dilantin level was high and the er staff immediately tried to get her dilantin level down. Additional information was received that the patient's increased blood pressure and heart rate started since (b)(6) 2015. The neurologist referred patient to the surgeon to assess patient's chest pain, increased heart rate and blood pressure. The relationship of these events to vns therapy is unknown to the neurologist. Clinic notes were later received for the generator replacement, which noted that the patient experienced dysphagia, pain in the left upper extremity and burning around the site of vns, which does not radiate in to the neck. Patient's vns was also reported to have moved due to loss of weight. The surgeon did not recommend any changes due to the migration. Notes also indicated that the patient's vagus nerve was impaired with hoarseness. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225867


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:40:28 AM
Model Number 304-20
Event Date 05/01/2014
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

Event Description
It was reported on (b)(6) 2015 that the patient is currently unhappy with the placement of the device. The physician referred the patient for a second opinion.

Event Description
Analysis of the returned lead portion was completed and confirmed an opening of inner tubing which exposed the conductive quadfilar coils. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the exposed surface and show what appears to be wear (smoothed surfaces) at the exposed portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
The explanted lead has been returned to the manufacturer where analysis is currently underway.

Event Description
Initially, it was reported that the patient experienced swelling and pain over the generator site. The patient was given antibiotics and the swelling resolved. It was reported that the patient was still experiencing pain at the generator site. The patient was seen for follow-up and it was reported that there was no infection and the patient was doing better. It was later reported that the patient was being shocked by the vns and that the device was interrogated and there were no problems. It was reported that the physician thought the patient's body may not be tolerating vns. It was reported that the patient wanted the device removed. It was later reported that the patient was experiencing shocks in his jaw and left arm and that the device was programmed off and the shocking resolved. It was reported that the patient would be scheduled for surgery to explore the lead. The patient's parents want the device explanted if nothing is found to resolve this shocking. The patient underwent lead replacement due to the increased discomfort over the last three months. The surgeon believed that the lead insulation directly under one of the tie-downs was worn away. The surgeon believes that the tie-down caused damage to the lead. It was later reported that the surgeon identified a break in the lead near the vagus nerve. It was reported that the patient's symptoms have completely resolved with lead replacement. The lead is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4128664


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:41:09 AM
Model Number 102
Event Date 07/28/2014
Event Type Injury
Event Description
It was reported that the vns patient was referred for surgery during an office visit on (b)(6) 2014 due to lead protrusion and painful stimulation. The patient¿s device was subsequently disabled. Patient manipulation or trauma is not believed to have caused or contributed to the lead protrusion. Diagnostic results showed normal device function at the time. Follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 due to painful stimulation and eri. The lead protrusion was determined to be minor and did not require revision surgery. The patient¿s device was programmed on at a follow-up office visit after surgery. The patient no longer had complaints of lead protrusion or painful stimulation. The explanted generator has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient continued to experiencing painful stimulation in her left arm. The patient had been experiencing an increase in seizures and pseudo-seizures since the device had been disabled due to the painful stimulation. The lead impedance was within normal limits. X-rays were taken and reported by the physician to be unremarkable. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block. 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. The patient was referred for surgery for the painful stimulation but no known surgical interventions have occurred to date.

Event Description
Additional information was received stating that the patient underwent a lead revision surgery (b)(6) 2015. The explanted lead was discarded and thus will not be returning to the manufacturer for analysis.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4035016


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:41:38 AM
Model Number 102
Event Date 11/18/2013
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013, note that the patient was experiencing an increase in seizures. It was noted that the magnet is helpful and that the patient has a cold and is on treatment. The patient was referred for prophylactic generator replacement. It is unknown if the increase in seizures is above the patient's pre-vns baseline frequency. Surgery is likely, but has not occurred to date.

Event Description
It was reported that the patient is suffering from a tremendous amount of breakthrough seizure activity. It was reported that medication changes are no longer helping the patient. The patient reported that she suffered a 64 minute seizure with loss of use of her left arm the prior saturday. The patient underwent generator replacement. System diagnostics with the new generator attached was within normal limits (1661 ohms). The generator was programmed on at the conclusion of the surgery. The generator has not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3561989


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:42:08 AM
Model Number 103
Event Date 10/22/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that, since implant, this vns patient was ¿not right, grumpy, acts like what the hell is going on. ¿ the patient was awake for one to three hours each night with restless legs. Clinic notes dated (b)(6) 2013 were received on (b)(4) 2013 indicating that this vns patient had a past medical history of obstructive sleep apnea and hypopnea and was on pap therapy. The patient had also had multiple deep venous thrombi in the left neck, upper chest, and left upper extremity. Device settings were provided. Follow-up with the medical provider showed that no additional information available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3489278


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:42:36 AM
Model Number 304-20
Event Date 01/21/2013
Event Type Malfunction
Manufacturer Narrative
Review of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional prior to distribution.

Event Description
On (b)(4) 2013, it was reported that this vns patient began experiencing pain on her left neck, left arm, and left chest on (b)(6) 2013. The pain was worse with magnet activation. The patient's physician believed the lead was broken and the patient was referred to get device checked. The pain began after the patient had a massage. Pain medication was prescribed by the patient's primary care physician. Follow-up showed that the patient reported constant pain in the left neck and left chest and discomfort in these areas with magnet mode stimulation (but not normal mode stimulation). No interventions were taken or planned. No diagnostics were run at this time, but the device was programmed off. The physician indicated that the patient was not having seizures with no anti-epileptic drugs and very low vns settings, so he suspected the seizures were due to the placebo effect.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986639


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:43:07 AM
Model Number 304-20
Event Date 09/01/2012
Event Type Malfunction
Event Description
Reporter indicated there had been no medication changes or vns programming changes, no trauma, and no manipulation of the vns. The patient has had no current increase in seizures. Diagnostics indicate normal function.

Manufacturer Narrative

Event Description
Reporter indicated the increased seizures were felt to be related to stress, and "it remains unclear if these would have been less had the generator been on".

Event Description
Programming history was reviewed. System diagnostics on (b)(6) 2012 were within normal limits. On (b)(6) 2012, the generator was disabled. The patient reportedly has increased daily attacks and still has a feeling of muscle contractions. These are, however, decreased in intensity. The programming system was determined to functioning well. The patient underwent surgery on (b)(6) 2013. The generator was tested, and the lead was checked for discontinuity. There were no abnormalities found. The neurosurgeon used insulation material for the generator and the lead. It is unknown if this affected the reported muscle contractions. Additional surgery may be likely but has not taken place.

Event Description
Surgery to replace the vns lead is planned, but has not occurred to date.

Event Description
Reporter indicated initially that a 's vns generator was unable to be interrogated, and was stimulating continuously. The patient had physiology tests (evoked potential measurements) performed and it was concluded by the physiologist no therapy was being delivered, and there was an issue suspected with the lead. Reporter later indicated the patient was having a slight increase in seizures in (b)(6) 2012. The patient was also experiencing left arm muscle contractions with vns stimulation. Lowering the vns pulsewidth did not resolve the issue, and the vns was disabled. The muscle contractions continued with the vns disabled. Vns diagnostics tests indicated normal device function. It is suspected per the reporter there may be a break in the lead insulation, or possible a lead break. Surgery to replace the vns lead is likely. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2820407


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:43:40 AM
Model Number 302-20
Event Date 09/11/2012
Event Type Malfunction
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a serious injury or death. Suspect medical device brand name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device type of device name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information, the suspect device is now the lead. Device manufacture date, corrected data: with the additional information, the suspect device is now the lead.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

Event Description
It was reported that the patient presented to an office visit on (b)(6) 2012 complaining of hoarseness during vns stimulation but the day that it began was unknown by the patient. The physician lowered the pulse width from 500 usec to 250 usec. The patient later reported in the morning of (b)(6) 2012 that she was experiencing a sharp pain at the generator site continually. The physician sent the patient to the emergency room. The patient was reevaluated by the physician on (b)(6) 2012, and high lead impedance was observed on both system and normal mode diagnostics. The patient clarified that the hoarseness was always present with stimulation, but the pain around her generator site started on (b)(6) 2012. She was experiencing the pain with stimulation and if she turned her head side to side or lifts her left arm. She denied any falls or trauma recently. Clinic notes dated (b)(6) 2012 indicate that the patient was complaining of sharp pain in the left upper chest and site of the generator. X-rays were taken when she went to the emergency room. The notes indicated that the x-rays were unremarkable. While the patient was in the emergency room, she went into violent tremors and was extremely tearful. It took about 15 minutes to calm her down and then she was back to baseline. There was no new neurological findings, and the violent tremors are reportedly not new and/or unusual for the patient, per the physician. The violent tremors have no relationship to vns. Follow up with the physician on (b)(6) 2012 revealed that the painful stimulation still isolated to the chest area near the generator site. The device was turned off on (b)(6) 2012. There were causal or contributory programming or medication changes precede the onset of the events. Although revision surgery is likely, it has not occurred to date. Ap and lateral views of the chest dated (b)(6) 2012 were received and reviewed by the manufacturer. The filter feedthru wires were intact at the generator, but the lead pin did not appear to be fully inserted into the generator (noted by how the lead pin does not extend past the second generator block. )there were two separate leads found within the patient. Lead a extends into the neck area and out of the view of the x-ray. No x-rays were taken of the neck area, so it is not possible to assess the lead in the neck area. The second lead, lead b, appears to no longer be on the nerve and is in the upper left chest area. It is difficult to determine which lead is connected to the generator because both leads extend down and behind the generator. No lead breaks were seen in the x-ray, and the lead is intact at the connector pin. Based on the x-rays provided, the cause of the high lead impedance is likely due to the lead pin being not fully inserted into the generator. However, if lead b is the lead the generator is connected to, then it may be that the lead is no longer on the nerve. The presence of additional micro-fractures in the lead can also not be ruled out.

Event Description
The patient had surgery on (b)(6) 2012. The surgeon removed the pin and tried with a new generator several times and continued to get high impedance. He elected to do a complete revision of the generator and lead. Lead impedance was okay at that time. Attempts for product return have been unsuccessful as the explanting facility will not release without a patients signed release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784912


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:44:16 AM
Model Number 300-20
Event Date 08/30/2012
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device x-rays reviewed by manufacturer; no gross lead discontinuities visualized.

Event Description
On (b)(6) 2012, it was reported that a vns patient had a generalized tonic-clonic seizure the earlier day (date unknown). After the seizure, the patient experienced painful stimulation in her chest. The patient's diagnostics were output status: limit, impedance: high ((b)(4);10000 ohms), eos = no. The last known diagnostics, current settings, device disablement after the event, and product information were unknown. X-rays were going to be taken and would be sent into the manufacturer for review. The patient was being referred for a full revision. On (b)(6) 2012, the patient's nurse indicated that the patient's chest and neck x-rays were available and would be sent into the manufacturer for review. The nurse stated that x-rays were taken because the patient was seen the previous day, and upon running diagnostics, high impedance (b)(4);10,000 ohms) was observed. The nurse also indicated that the patient has had very few seizures since being implanted with vns; however, the patient had a generalized tonic-clonic seizure the previous week. For the past month, the patient experienced discomfort in her chest with stimulation. (this was not a shock-like sensation. ) the nurse stated that high impedance was first seen on (b)(6) 2012. It was stated that the device was not disabled. The patient was still experiencing her normal voice alteration; therefore, the device was not programmed off as it appeared that the patient was still receiving stimulation. When asked about manipulation or trauma, the nurse stated that when the patient first called regarding the discomfort, she indicated that she was dizzy. The nurse was pretty sure, but could not confirm, that the patient had fallen at that time, which could explain the dizziness and the painful stimulation. Additional information was received with the patient's x-rays. On (b)(6) 2012, the patient had a partial complex seizure at 14:10 and had a grand mal seizure at 15:10. The patient felt pretty beat up: the patient bruised up her shoulder and back. The patient was evaluated in urgent care and was told that there were no fractures, only bruise. The patient denied any missed medication and no acute illnesses. On (b)(6) 2012, the patient reported dizziness and her medication was adjusted. On (b)(6) 2012, the patient reported that she had missed medications. Since (b)(6) 2012, the patient did not report dizziness and these were the first seizures since the appointment. The patient reported a "different" feeling regarding the generator. It was not a shock, but just different. The patient had a number of seizures since her last visit. The device was stimulation her voice but she felt a weight in her chest with stimulation. The seizures were possibly secondary to an automobile accident. The patient had significant ecchymosis and pain in the left upper arm and should from the fall on her should with the seizures. It was assessed that the patient had the gtc possibly secondary to a fractured lead on the vns. The x-rays were assessed and it was written that the vns wire appears to have a break or crack based on high impedance. Vns replacement including wires was likely. The device was interrogated and diagnostics were run. X-ray images were reviewed by the manufacturer. The generator was visible and appeared to be normally placed. The connector pins appeared to be fully inserted inside the connector blocks. The feedthru wires also appeared intact. The lead was also visible. Lead was present behind the generator. There were no suspect fractures, discontinuities, or sharp angles visible. The lead wires appeared intact at the connector pins. The patient underwent total revision on (b)(6) 2012. The explanted generator and lead were received on (b)(6) 2012 and are currently undergoing product analysis. The returned product form indicated that the lead was explanted due erosion of the lead and parasthesia in the chest.

Event Description
An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Product analysis on the generator showed that the high impedance noted in the lead section was not duplicated in product analysis. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned but did not cause or contribute to a death or serious injury.

Event Description
Additional programming history was reviewed on (b)(6) 2012. High impedance was first seen on (b)(6) 2012. Impedance values and output status varied with diagnostics.

Manufacturer Narrative
Review of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769777


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:44:43 AM
Model Number 105
Event Date 08/13/2012
Event Type Injury
Event Description
A school nurse reported that she has a vns patient who has been experiencing pain in his chest at the generator site and also in his lower arm/hand on the left side. This pain has been constant for the past 2 weeks according to the reporter. In addition to this, the nurse reported that the lead is protruding in the neck, and the generator site has opened. Thus far no further information has been attained.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2756656


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:45:19 AM
Model Number 302-20
Event Date 07/26/2012
Event Type Malfunction
Manufacturer Narrative
Describe event or problem, corrected data: information regarding the patient's painful stimulation was inadvertently omitted from mdr report #1. Date of event, corrected data: the initial mdr report inadvertently reported the incorrect event date. The correct date is provided.

Event Description
Reporter indicated that at the surgical consult on (b)(6) 2012, the patient reported she was having painful stimulation in her neck and left arm which was described as a shocking sensation. Vns generator replacement was planned as it was felt the generator was nearing end of service and the patient was having painful stimulation. The painful stimulation may be related to the lead fracture, but this was not certain.

Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

Event Description
Reporter stated x-rays were done prior to the surgery and no anomalies were noted. The patient had no known trauma and does not manipulate the vns. The patient was seen in surgical consult on (b)(6) 2012 and the vns was reported to be working properly at that time, but diagnostics were not charted.

Event Description
Reporter indicated that during vns generator replacement surgery for reported generator end of service, it was noted the lead was fractured. A new vns lead and generator was implanted. The lead was discarded at the surgery. The vns generator was returned for analysis and no anomalies were identified. The generator was not at end of service. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2715879


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:45:47 AM
Model Number 106
Event Date 12/11/2015
Event Type Injury
Event Description
It was reported that the patient developed a post-surgical infection. The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics. The symptoms of infection had reportedly resolved at that time. Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm. The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis. No interventions for the thrombophlebitis have occurred. The patient was not admitted to the hospital. The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm. A review of device history records showed that the generator was sterilized 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=5397383


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:46:18 AM
Model Number 102
Event Date 12/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received from the treating nurse indicating the reason for the reported pain was unknown and was not associated with vns stimulation. The pain was reported to have been located in the chest area and even some in the neck and left arm. Diagnostics at the time were within normal limits. Moreover, the nurse reported the patient's seizures increased; however the patient is noted to have an increase in seizures yearly. Analysis was completed on the returned generator. Analysis of the generator indicated 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.

Event Description
It was reported by a nurse that a vns patient was explanted due to local pain and sensibility. The patient was reported to have an increase in seizures after explant; however the patient's pain resolved after explant. The explanted generator was returned to the manufacturer and currently undergoing analysis. Good faith attempts to obtain further information from the treating nurse have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465722


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:46:58 AM
Event Date 11/22/2011
Event Type Malfunction
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
Attempts to obtain additional information have been unsuccessful to date.

Event Description
It was reported that during a follow up visit, high lead impedance was noted on diagnostics. The patient was also reporting numbness in his left arm, however it is unknown if this was related to the high impedance. No trauma was reported. Exact diagnostics were not provided. Attempts for additional information are underway.

Event Description
Follow up with the patient's implanting hospital was performed however they would not provide the patient's implant information as patient authorization is required.

Event Description
Additional information was received on (b)(4) 2012, indicating that the patient underwent revision on (b)(4) 2012. The explanted generator and lead were returned to the manufacturer and product analysis has since been completed. During generator product analysis, results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications and there were no adverse functional, mechanical, or visual issues identified with the returned generator. An analysis was performed on the returned lead portions. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified in the returned portion of the lead. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the high impedance; however as a portion of the lead, including the electrodes, was not returned an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2382735


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:47:31 AM
Model Number 300-30
Event Date 12/02/2011
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2011, were received from case management which revealed that the patient had experienced chest pain for the past (b)(6) months, which radiated down her axilla and arm. The patient has had catamenial seizures affecting her right arm since age fifteen. She has had spells of right arm stiffening two years prior to her first generalized tonic-clonic seizure at age (b)(6). It was reported that vns has "reduced her seizures from daily to only associated with menses. " the patient was seen on (b)(6) 2011, on an urgent basis due to a new onset of headaches that required hospitalization, as well as seizures. The patient's seizures have been variable over the years from five seizures per day, to as many as twenty per day (30% during wakefulness and 70% waking her from her sleep), especially during ovulation and onset of menses. However prior to vns, she had them outside her menses as well. The patient experiences multiple focal seizures around her menses. The patient's chest pain is described as sharp affecting the lateral and posterior region of her left chest. However, palpation does not recreate pain, rather, the pain is created by stretching. The patient takes hydrocodone and ibuprofen for the left chest pain. The patient was concerned that vns may be causing the pain. Further more, the patient called the physician on (b)(6) 2011, as documented in the clinic notes because she was having chest pain and went to a cardiologist who alleged that she has a "broken wire" in her vns. The patient reported that the cardiologist felt around it and stated that he "felt a pulse where it was broken. " the patient reported that the pain was so bad, when she got home that she took a percocet, but the pain still persisted around her heart area, left axilla, and down her left arm to her hand. The patient wanted to know what to do because the pain was progressing. The patient was referred for a stat chest x-ray to check the leads. However, no lead breaks were noticed by the physician during a review of the x-rays. The patient was prescribed percocet. The patient was also referred for a consult with a surgeon for a new generator or vns adjustment. The x-rays were not sent to the manufacturer for analysis. The patient had generator replacement surgery on (b)(6) 2011. Attempts for additional information from the patient's neurologist's office have been unsuccessful thus far. The reason for generator replacement is not known at this time. The diagnostics performed on (b)(6) 2011, did not indicate that there was a device malfunction. A batter life calculation was performed with the history available in the in-house programming database, and the results were approximately 3. 91 years until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2387860


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:47:58 AM
Model Number 102R
Event Date 11/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2015 noted that the patient complains of pain in her left arm, left leg and at time in the left side of her face for approximately 3 weeks. It was noted that the patient was unsure if the pain was coming from her vns. It was also noted that the patient noted there was a knot on her back where the generator is placed. The patient was referred to the surgeon to determine what the next step would be. It was later reported that the patient underwent generator replacement surgery. It was reported that the explanting facility does not return explanted devices for analysis; therefore, no product analysis can be performed. The surgeon indicated that the patient underwent generator replacement due to pain. The surgeon indicated that the pain was not associated with stimulation, but rather the presence of the device. Device diagnostics were within normal limits (dc dc -2). Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5417620


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:48:22 AM
Model


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:48:48 AM
Model Number 103
Event Date 11/01/2015
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2016 note that the patient's seizure activity has increased over the past two months. It was reported that during this time she has had problems with her device. It was noted that the frequency of the seizures are unknown, but have increased according to patient report. It was reported that the patient had 5 seizures over the weekend. Use of the vns magnet stopped the seizures. It was also noted that the patient's generator is moving and popping out of place. The patient reported that she sometimes has to move it back to where was which is causing pain when she moves her left arm. The patient also reported that when she moves the generator it will come on by itself. The physician adjusted device settings and referred the patient for generator replacement and pocket revision. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5435959


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:49:19 AM
Model Number 102
Event Date 11/25/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported through an article that a patient with a vns for refractory depression presented with bradycardia and orthostasis 9 years after initial implant of the vns. This was reported by the patient as recurrent syncopal episodes occurring for duration of 1 month. The patient reported 3 - 5 syncopal episodes occurring every other day, with loss of consciousness lasting 5 - 7 minutes. These episodes were preceded by lightheadedness, shortness of breath, nausea, and chest pressure radiating to her left arm and the patient also denied any triggers. The patient also denied loss of consciousness, which contradicts the initial report. The patient's past medical history was notable for anxiety and bipolar disorder associated with severe refractory depression. Over her lifetime, she had been treated with multiple lines of medication and over 70 documented electroconvulsive therapy treatments. Upon the patient's admission, her vital signs were within normal limits, cardiac examination was unremarkable, cardiac evaluation including measurement of cardiac enzymes and 2-dimensional echo were all within normal limits. Serial ekgs were significant only for occasional sinus bradycardia in the low 50s. Urine drug screening was negative and the ct was normal. Records from an outside hospitalization a month prior for these same symptoms demonstrated a normal ct angiogram of the head and neck, normal continuous eeg monitor, and continuous telemetry without arrhythmias. During the first half of admission, the patient's blood pressures fluctuated significantly. These findings were note despite having been adequately hydrated with crystalloid solution prior to the assessments. Additionally, a complete neurologic exam and workup had been unremarkable and her medications were reviewed and deemed non-contributory. As a result, a decision was made to inactivate the vns. Variation in systolic and diastolic blood pressures diminished in a statistically significant manner after the vns was inactivated. The patient also endorsed improvement of her symptoms. The patient was then deemed stable and discharged.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446594


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:49:43 AM
Model Number 302-20
Event Date 04/20/2011
Event Type Malfunction
Event Description
It was reported that the vns patient would be having her generator replaced due to end of service. Information was later received from the patient indicating that her heads were also replaced because they were "bad. " operative notes received from the surgeon's office noted that the patient had been experiencing painful stimulation down her left arm and upon examination of the lead during surgery found that there was a break in the insulation. This was the anomaly that prompted the lead replacement and was described ass a "break in the electrode insulation with fluid bubbles inside the electrode sheath. " the site believes that the painful stimulation is related to be opening in the insulation as per the notes. Diagnostics following surgery were normal. The explanted lead was returned and underwent analysis. The opening in the insulation was not confirmed and no anomalies were found however the electrode portion of the lead was not returned.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2199025


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:50:12 AM
Model Number 302-20
Event Date 02/04/2010
Event Type Malfunction
Event Description
It was reported that high lead impedance was read in system , normal and magnet mode diagnostics during a follow up visit. Further information received from the nurse indicated the patient was not able to perceive normal stimulation as settings were increased to test the perception and were concluded to be negative perception from patient. Moreover, the patient reported pain from the generator to the left arm while performing movement since the past two months and feels the generator is moving. No patient trauma was reported at the moment and the device was not disabled as the patient did not agree to have it disabled. X-rays were taken and evaluated by the manufacturer. The review of the x-rays revealed the generator was placed in the left chest in normal orientation. The filter feed-thru appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. The lead body was coiled beside the generator in the chest region, and there was no portion of the lead body located behind the generator that could not be visualized. Even though the lead body in the neck region could be visualized, the image quality in this area was poor. No obvious acute angles were observed in the portion of the lead body that could be assessed. However, a discontinuity in the lead body was observed in the chest region near the generator. At the moment interventions planned are unknown as good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1634010


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:50:41 AM
Model Number 302-20
Event Date 08/14/2009
Event Type Malfunction
Event Description
It was reported to manufacturer that the vns patient was experiencing a recent increase in seizure activity, below the pre-vns baseline, and a sudden onset of pain on the left side of the neck during stimulation, which sometimes would travel down the left arm. The patient additionally reported sometimes feeling pain in the jaw during stimulation and is not always able to feel stimulation. The device settings are so low (less than 1ma output current), and therefore, a system diagnostic test was not able to be performed. During the office visit with the surgeon for a consult, the output current was increased to 0. 75ma to run a normal mode diagnostic test which resulted in output status = ok, lead impedance = ok, dcdc = 0, and eri flag set to no. X-rays were taken and sent to manufacturer for review. There were no lead discontinuities, or any other obvious anomalies, visualized on the lead portions which could be contributing to the reported events. There was no report of patient trauma or manipulation of the device prior to the onset of the reported events, and the device settings had not been altered in two years. The patient was referred for a full revision of the vns device as the physician and the patient felt that the device was not performing as intended. During revision surgery, the surgeon noted that there was "significant scarring with adherence of the vns stimulator electrodes to the left vagus nerve. Otherwise, there were no significant findings or obvious cause for the lead malfunction". The explanted lead and generator have been returned to the manufacturer where analysis is underway. The patient has been seen for follow up since the revision surgery, and the device is programmed on and the patient is pain free and the seizures are once again under control.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1521133


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:51:11 AM
Model Number 102
Event Date 12/01/2006
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that a vns pt experienced drainage at the chest incision site and pain when the left arm was moved. This led the treating physician to determine that the pt had an infection at the generator site. The physician determined that pt manipulation of the incision site caused the infection. The pt was treated with antibiotics and sent to wound management in an attempt to save the vns device. When the pt was seen at a follow-up appointment approximately one month later, the infection had cleared and the incision site was well healed. Review of device history reports for both the generator and lead confirmed that the devices were sterilized prior to distribution. The device was explanted in 2007 even after the infection resolved, due to the mother's election because of the patient's coughing at night keeping her awake. Pt recently has been re-implanted with a new system.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1185217


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:51:42 AM
Model Number 304-20
Device Problem Inappropriate shock
Event Date 10/16/2015
Event Type Injury
Manufacturer Narrative

Event Description
The physician's office reported that they only saw the patient to turn off her vns, that they were not the patient's primary neurologist. Good faith attempts were made for further information from the primary neurologist but no further information was received. Product analysis was completed on the lead. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device.

Event Description
It was reported that the patient had her vns explanted on (b)(6) 2015 due to an unknown reason. The physician later reported that the reason for explant was that the device was shocking her although it was off and battery out. That it was uncomfortable for the patient and she didn't like that she could see the wire over her clavicle. It is unknown when and where the patient's generator had been implanted as the patient had previously been explanted in 2014 and has obviously since been re-implanted but it is unknown when. It was later reported that the lead was explanted on (b)(6) 2015 due to pain and that the patient's generator was explanted on (b)(6) 2014 due to pain when moving her left arm. She stated the electrodes were left on the nerve and the remaining lead body. It was also reported that the patient's device was explanted due to lack of efficacy. Good faith attempts for further information from the physician have been unsuccessful. The explanted lead was returned for product analysis on 11/03/2015. The generator has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5217276


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:52:11 AM
Model Number 106
Event Date 05/02/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting. Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation. The condition progressed to constant sensation of tightness in chest and shortness of breath of approx. 1 hour duration until he taped the magnet over the device. The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred. Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms. It was stated that the lead impedance was checked in varying neck positions. The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system. X-rays were taken but nothing conclusive could be diagnosed by the providers. The x-rays were not provided to the manufacturer for review. The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted. The explanted generator was discarded by the explanting facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5685905


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:52:38 AM
Model Number 103
Event Date 03/01/2016
Event Type Injury
Event Description
It was reported that the patient contacted the surgeon complaining of irritation at the generator site. The patient reported an inability to move the left arm and that the generator is extruding from the site. Infection was ruled out. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5574939


Title: Re: Arms
Post by: dennis100 on November 29, 2016, 09:53:17 AM
Model Number 102
Event Date 10/16/2014
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient had recently been hospitalized for seizure disorder. The patient recently underwent generator replacement surgery and subsequently experienced pain the left arm and chest, dizziness, and lightheadedness. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340994


Title: Re: Arms
Post by: dennis100 on December 09, 2016, 09:19:25 AM
Model Number 106
Event Date 10/22/2016
Event Type Injury
Manufacturer Narrative
Udi of suspect device: (b)(4).

Event Description
It was reported that a patient felt a "pop" around her generator site two weeks prior and then started feeling pain at the generator site. The patient also felt that the generator was moving when she moved her arm, and she felt decreased stimulation. Revision surgery was planned, but no known surgery 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=6137351


Title: Re: Arms
Post by: dennis100 on January 06, 2017, 07:31:33 AM
Model Number 102
Event Date 10/29/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was assaulted and fell off his bicycle. Immediately following the incident the patient began experiencing painful stimulation at the generator site. Over the next few days the patient experienced pain at the generator site, left arm, and the electrode site as well as pain with stimulation in his shoulder. The device was later disabled and a system diagnostics test found that the lead impedance was within acceptable limits. The patient was later referred for a vns replacement due to the pain. At the replacement surgery a new generator was connected to the existing lead and the impedance was found to be within acceptable limits. The surgeon evaluated the lead and noted that there was no obvious discontinuities or fluid in the lead. Therefore the surgeon decided to only replace the vns generator at that time. The explanted generator has not been received to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6158581


Title: Re: Arms
Post by: dennis100 on February 07, 2017, 02:30:13 AM
Model Number 302-20
Event Date 01/19/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.

Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.

Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.

Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, 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 generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. 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) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248


Title: Re: Arms
Post by: dennis100 on February 10, 2017, 04:37:47 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2012
Event Type Injury
Event Description
It was reported that the patient had the vns device disabled for over 5 years now. The device was disabled due to an increase in "athetoid" style of seizures after generator replacement. The patient had an arm swing that was much more notable after device replacement and so the patient's device was disabled. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6284845&pc=LYJ


Title: Re: Arms
Post by: dennis100 on February 10, 2017, 04:38:35 AM
Model Number 102
Event Date 01/25/2013
Event Type Injury
Manufacturer Narrative

Event Description
The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.

Event Description
Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.

Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972914


Title: Re: Arms
Post by: dennis100 on February 12, 2017, 09:03:09 AM
Model Number 102
Event Date 01/01/2009
Event Type Injury
Event Description
A vns flowsheet was received which noted on patient's visit on (b)(6) 2010 the patient decribes an increase in seizure frequency with right arm tremors and spells of confusion. It is unknown if the increase was above the patient's pre-vns baseline frequency. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Analysis of programming history.

Event Description
Further follow-up revealed that the patient's increase in seizures was below the patient's pre-vns baseline frequency. The physician indicated that there was no relationship between the increase in seizures and vns therapy. The physician reported that the increase was a single episode where the patient lost consciousness in the shower and was not observed. The physician noted causal or contributory external factors that predeeded the onset of the increased seizures as the patient had stopped treatment with cpap for obstructive sleep apnea. The physician noted that the patient has a previous diagnosis of obstructive sleep apnea. The patient underwent uvulopalatopharyngoplasty in (b)(6) 2012 and that the obstructive sleep apnea was previously severe in 2009. The patient did not do a follow-up study after the surgery. Attempts to obtain additional information on the obstructive sleep apnea have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3025597


Title: Re: Arms
Post by: dennis100 on February 13, 2017, 04:34:15 AM
Model Number 302-20
Event Date 10/31/2011
Event Type Malfunction
Event Description
Additional information was received on (b)(4) 2012, when it was discovered that the vns patient had prophylactic generator replacement that day. Pre-op system diagnostics showed results within normal limits of output=ok/lead impedance=ok/dcdc=2/eri=no. System diagnostics after generator replacement again showed results within normal limits of output=ok/lead impedance=ok/impedance value=2366ohms and output=ok/lead impedance=ok/impedance value=2381ohms. The patient was then programmed to the same settings as prior to surgery; output=1. 5ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. The explanted generator was returned to the manufacturer on (b)(4) 2012, for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
"type of report", corrected data: inadvertently did not check "30-day" on initial report.

Event Description
On (b)(6) 2012, clinic notes from a vns treating neurologist were received by the manufacturer. Review of the clinic notes dated (b)(6) 2011, revealed that the vns has been very helpful with the patient's seizure control but that at the patient's last visit, the patient had feelings of neck discomfort associated with stimulation. The pulse width was lowered which provided relief of the discomfort, but now the patient is experiencing feelings of "insecurity". She perceives that she may be at a greater risk for seizures since the pulse width was lowered and stated that she would like to have the pulse width increased again. Upon increasing the pulse width, the patient experienced a sensation of numbness and tingling down her left arm with stimulation. The pulse width was therefore turned back down to 250 usec and the signal frequency was increased to 25hz. The physician stated that if the patient continues to have these premonition-type feelings the output current may be increased. The physician states that he is concerned that the sensation she is getting upon stimulation are indicative of a lead fracture. He states that x-rays were taken which showed no evidence of a lead discontinuity. The patient's settings were output=1. 5ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The physician further states that if there are any worsening of the patient's symptoms or decreased seizure control they will have a full revision surgery. The physician later stated that the painful stimulation, numbness, and hypoesthesia were first noticed on (b)(6) 2011. No causal or contributory programming or medication changes preceded the events. No patient manipulation or trauma occurred. The patient's most recent settings are output=1. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. The physician stated that she does not have a medical history of numbness or hypoesthesia prior to vns. The patient is having a full revision surgery due to a likely fractured lead according to the physician although no diagnostics were reported that would confirm high impedance. Although surgery is likely, it has not yet occurred.

Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2504493


Title: Re: Arms
Post by: dennis100 on February 23, 2017, 01:43:04 AM
Model Number 104
Event Date 01/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that the patient reports that the vns wires shock her even when the device is off. The patient indicated that she feels like she has lost all use of her left side. It was noted that the patient suffered a fall on (b)(6) 2014, striking the area near the vns. There was no bruising or edema that resulted from the trauma. The patient begun to complain of weakness in her left arm and occasional tingling in her left leg. It was noted that this has not impacted the patient's activity level. The physician programmed the device off on (b)(6) 2014 and x-rays were performed to check for possible damage or movement of the vns caused by the fall. The physician referred the patient to the surgeon because he believed the device has migrated significantly lower than initially placed. The physician reported that he felt the device had migrated some time ago because an x-ray from (b)(6) 2014 showed the device in the same location as the current x-ray. The patient underwent prophylactic generator replacement. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4348399


Title: Re: Arms
Post by: dennis100 on February 23, 2017, 01:44:00 AM
Model Number 103
Event Date 10/20/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Additional information was received that the patient's device was turned on during (b)(6) 2014 and that the patient is doing well. Patient also experiences pinching sensation in her chest during stimulation and when she lies down. Patient's pain when turning her head was reported to be better and was attributed to be due to patient having a bulging disc.

Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300491


Title: Re: Arms
Post by: dennis100 on March 04, 2017, 02:03:25 AM
Model Number 102
Event Date 12/13/2013
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
It was reported that the explanting facility destroys explanted devices; therefore, the device will not be returned for analysis.

Event Description
Clinic notes dated (b)(6) 2013 were received which indicate that at the (b)(6) 2013 visit, the vns output current was maintained at 1. 0 ma and the duty cycle was decreased from 38 to 35%, by decreasing the on time from 60 seconds to 30 seconds and decreasing the off time from 1. 8 minutes to 1. 1 minutes. The patient had a flurry of seizures and was therefore seen in the emergency department on (b)(6) 2013. The flurry was described as: "rhythmic twitching of muscles in arms and legs and change in behaviour - he becomes agitated. He does not lose consciousness or have generalized t/c [tonic-clonic] activity. " clinic notes indicate the patient has improved, but is not quite back to normal. The patient is "twitchier" than usual, by which they mean he is having more myoclonic jerks. The patient had no breakthrough generalized tonic clonic seizures since the physician increased the vns settings. On (b)(6) 2013, the patient's mother called the surgeon's office and stated that the patient is "actively seizing". The patient had the vns generator replaced due to end of service. Follow up with the physician found that only the generator was replaced, not the leads. The increase in seizures was believed to be due to the generator being at end of service. Seizures increased as the battery neared end of service. Only the myoclonic seizures increased. There was no causal or contributory programming, medication or other external factors preceding the onset of the increase in seizures only that the battery was at end of life. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3574260


Title: Re: Arms
Post by: dennis100 on March 10, 2017, 05:05:58 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type Injury
Manufacturer Narrative

Event Description
The surgeon's office reported that the patient was experiencing pain at the generator site. The patient had slipped in the bathtub hitting her head and chest. After this incident the patient reported that there was a stabbing pain which radiated from around the site of her device in her neck and chest to her shoulder and down her left arm. The pain resolved when the device was disabled. Diagnostics were performed on the patient's generator after her fall and it was noted that the results were within normal limits. The patient then underwent generator replacement surgery. There was no noted reason to replace the lead at the time of the generator replacement and diagnostics were within normal limits with the new generator per the implant card. Information was then received that indicated the patient had undergone lead revision surgery 7 days after the generator was replaced due the pain at her lead site. No high impedance was seen and there was no lead discontinuity observed either. The explanted products were discarded. No product return is expected. No other information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6358184


Title: Re: Arms
Post by: dennis100 on April 18, 2017, 11:37:05 PM
Model Number 101
Device Problem No Known Device Problem
Event Date 12/01/2016
Event Type Injury
Event Description
It was reported by the physician that the patient had requested to have the vns explanted as it has reached end of service and it was bothering her. It was reported that the patient was experiencing an electric shock in her chest that spreads to her whole left arm and neck randomly. She had also complained of experiencing pain in her chest around her vns generator and neck when yawning. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

Event Description
Further follow up with the physician revealed that the explant would be for the patient's comfort. It was also reported that the generator battery is dead and that the patient's seizure control has not changed since the generator battery has died.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6374516


Title: Re: Arms
Post by: dennis100 on April 21, 2017, 03:32:56 AM
Model Number 102
Event Date 11/04/2007
Event Type Injury
Event Description
It was reported to manufacturer by the vns pt that they believe the generator has migrated after putting pressure on the elbow. Additionally, the pt reported that the implanting surgeon and the treating physician were contacted to report the event. Attempts to obtain additional information from the implanting surgeon and the treating physician have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=958441


Title: Re: Arms
Post by: dennis100 on April 21, 2017, 03:33:44 AM
Model Number 302-20
Event Date 11/21/2007
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death.

Event Description
It was reported to mfr that the vns pt was experiencing a sudden onset of painful stimulation in the neck and down the arm. The onset of the event followed trauma in which the pt had threw a baseball up in the air and it struck directly on the generator site. The device subsequently was turned off as the stimulation became intolerable, despite having decreased the device settings. The treating physician had performed a sys diagnostic test on the device following the reported trauma at an office visit, and the results indicated normal device function. The physician ordered x-rays to evaluate the continuity of the sys. It is unk what was observed on the x-rays and the x-rays have not been sent to mfr review. The pt was referred to surgery and during surgery a sys diagnostic test was performed and revealed high lead impedance. The surgeon opted to replace the generator only. The new generator was connected to the existing lead and the device was tested outside the chest pocket and revealed normal device function. The generator was then placed inside the chest pocket and the sys diagnostic test revealed high lead impedance. The surgeon opted to leave the new generator connected to the existing lead implanted in the pt. The pt had a follow up visit for the initial interrogation and dosing, and it was reported that the pt is "doing very well" and "everything is fine. " the explanted generator has been returned to mfr and is pending the analysis findings. Attempts to obtain add'l info from the treating physician and surgeon are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968664


Title: Re: Arms
Post by: dennis100 on May 06, 2017, 09:15:48 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 03/21/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the patient that she was having some shocking feelings that would come from the area of the vns generator. She explained that there is some brain tissue damage that was not there before during her er visit that she had for an unrelated issue. The patient noted there was a high possibility of stroke and she was wondering if this could be due to vns because it started with a shock of the neck on the left side where the implant was located, up the neck, down the arm, and then slowly down the leg. She explained she was having a hard time lifting her leg. The vns representative later reported the patient had complained of pain in the chest and she doesn't know why; however, it was explained that the pain had gone away. It was later reported by the physician's office that this is a very complicated case and he believes it goes way deeper than just vns. The generator was noted to be at end of service; however, the physician did not know if he would refer for a replacement due to the complexity of the case. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6499043


Title: Re: Arms
Post by: dennis100 on May 07, 2017, 07:58:47 AM
Model Number 105
Event Date 04/30/2014
Event Type Injury
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014 to reposition her generator.

Event Description
Initially, it was reported that the generator was loose in the pocket and is moving around. It was reported that the patient was able to reposition it when she moves her arm. X-rays were performed and sent to manufacturer for review; however, were inconclusive in confirming that the generator has migrated as there was no prior image for comparison. It was later reported that the patient was scheduled for surgery to revise the generator. Clinic notes dated (b)(6) 2014 note that the patient was seen for pre-operative visit prior to generator revision. It was noted that the patient continues to have episodes where the generator migrates upward when the patient raises her arms above he head. No known surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4118837


Title: Re: Arms
Post by: dennis100 on May 13, 2017, 03:26:54 AM
Model Number 302-20
Event Date 09/18/2008
Event Type Malfunction
Manufacturer Narrative
Conclusions: device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
It was reported to manufacturer that during surgery for a generator replacement due to end of service, the surgeon visualized a lead break in the lead. Both the lead and generator were subsequently replaced. Further follow up with the surgeon revealed that only the outer tubing was broken on the lead on the portion of the lead near the generator. The surgeon further explained that the pocket that formed around the generator was very tight, and that, it maybe possible that due to arm movement for years, the insulation could have cracked immediately beyond the rigid end of the lead attached to the generator. Attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date. Additionally, attempts to obtain the explanted lead and generator for analysis have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1203124


Title: Re: Arms
Post by: dennis100 on June 03, 2017, 12:25:20 AM
Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction   
Event Description 
Reporter indicated that upon receiving a safety alert letter regarding potential short circuits in the lead, she was certain that the patient had a short circuit. The reporter had previously indicated that the patient has a shocking sensation in the neck, and had also denied that there was a shocking sensation, but that the patient felt a tightness in left pectoral region when the left arm was raised, and is now again alleging that the patient feels a shocking sensation. All attempts for more information, including programming history, so as to confirm or rule out a shor circuit, have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1505059


Title: Re: Arms
Post by: dennis100 on June 09, 2017, 03:57:40 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/14/2017
Event Type Injury
Event Description
It was reported that a generator pocket revision surgery was scheduled for the patient. The patient reported that she felt like there was a little movement within the pocket, so the physician planned to perform exploratory surgery. Follow up with the office of the surgeon showed that the generator movement was first noted by him in an office visit. Review of the operative report from the patient¿s previous generator implant surgery did not show a reference to the generator being sutured within the pocket. In the consult appointment, the surgeon noted that the generator did have some mobility within pocket and moved slightly to the left. It was assessed that the generator was causing left chest and arm pain via physical irritation to the pectoralis and biceps muscles. The patient and caregiver requested the surgeon to move the generator medially. Surgery to reposition the generator was completed as planned. In this surgery, the surgeon placed a non-absorbable suture to secure the generator within the pocket. No additional pertinent information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6572484


Title: Re: Arms
Post by: dennis100 on June 11, 2017, 08:27:04 AM
Model Number 103
Event Date 02/26/2010
Event Type  Injury   
Manufacturer Narrative 
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description 
It was reported to mfr that the recently implanted vns pt developed an infection at the generator site which has spread under the pt's left arm. The surgeon noted that the dressings may not have been properly changed following implantation procedure, and that the pt may have picked at the incision site. Penicillin was prescribed, and it was reported by the pt's mother that the pt has (b) (6) and a possible staph infection; however, the results of the lab analysis from culture samples taken have not been received by the mfr to date. Additionally, it is likely that surgery has already occurred where the device was removed; however, confirmation of surgery has not been received by the mfr to date. Good faith attempts to obtain additional info have been made, but no additional info has been received to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1666450


Title: Re: Arms
Post by: dennis100 on July 05, 2017, 12:26:56 AM
Model Number 102
Event Date 09/30/2010
Event Type Injury
Event Description
It was reported that a vns pt experienced pain in his arm and shoulder along with coughing during stimulation. The event was reported by the pt's wife and indicated the event happened one time only. Additional information was received from a company representative indicating the pt was reporting a sharp stimulation every 2 mins that last up to an hour. The stimulation was "more in the neck first, then it went to the chest and towards the back" according to the pt. Pt described that after the hour of pain; the system will "shut itself off" and would then "turn itself back on". The pt was implanted in 2006 and was seen on a yearly basis. Since last (b)(6), he has been in every 6 weeks with the same type of complaints, which prompted the frequent visits. The treating physician would adjust the settings, the pt would feel fine in the office, and the pt would go home. He would feel fine there for a while, but then the device would seem to "malfunction" and he would need to come back in to the physician's office. However, based on previous diagnostics, the device would show to be working properly despite the pt's complaints. Additional information was received through clinic notes dated (b)(6) 2010. Notes stated that "pt has not had seizures but vns is going off every 2 minutes, at times for over hours, but is extreme sharp pain that is very different. He did not wish although i advised to place the magnet over his stimulator to turn it off, but he said that he has fear of return of his seizures". X-rays were received and evaluated by the manufacturer. Review of x-rays indicated the generator placement appeared to be normal, and the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. No obvious lead discontinuities or acute angles were observed in the observed portions of the lead body that could be assessed. Although there was some lead behind the generator. Additional information was received from the pt's wife indicating her husband went to the specialist to go over the prognosis and his vns started shocking him at a higher voltage than he usually has. The wife indicated that there was nothing done to the device and the pt was not near electrical equipment that would have made it go off. Moreover, the pt's wife indicated the pt has chronic headaches ever since the device started shocking him and they are afraid to use the microwave in the house because he says it shocks him every time he uses it. At the moment, full revision surgery is planned at this time. Good faith attempts to obtain additional information from the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1905622


Title: Re: Arms
Post by: dennis100 on July 07, 2017, 03:16:33 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 04/26/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having pain due to upgrading from a 103 to a 106 due to the increase in size of generator. Clinic notes indicated that the patient had had some pain at the generator site since the procedure. She also had felt a continuous electric shock in her chest wall since her replacement that radiated to her left arm and left upper abdomen as well as numbness down her left arm. After she turned her generator off, her symptoms improved. She continued to have daily auras and seizures and had the worst period of seizures that she's had in years. For these reasons the surgeon recommended replacement of her generator with a m103 due to previous good results. The surgeon's office indicated that they believed that the continuous shocking may be caused by autostimulation. The issues resolved when the device was turned off, but the patient's seizure rate increased because of this. The surgery was indicated to be due to medical necessity. The patient was replaced due to painful stimulation. Lead impedance issues were not detected prior to the replacement. Per the surgeon, he did not observe any lead defects on the visible portion of lead during surgery. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6668568


Title: Re: Arms
Post by: dennis100 on July 08, 2017, 04:21:24 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 05/04/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because analysis will not yield any relevant information to the reported event of infection.
 
Event Description
The patient's caregiver noticed some blood on patients shirt. They looked under his shirt and observed swelling and bruising to the generator site on left side of chest and arm. Patient was implanted with vns approximately a month prior to the event. Patient did not have a fever. The patient later had surgery to remove the generator and electrodes as it was infected and abscess was present. Per the medical professional, it seemed like an isolated stitch infection but the doctor recommended removing the whole thing. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6632410


Title: Re: Arms
Post by: dennis100 on July 27, 2017, 11:27:40 AM
Event Date 01/05/2011
Event Type  No Answer Provided   
Event Description
Explantation of cyberonics vns demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061420


Title: Re: Arms
Post by: dennis100 on August 04, 2017, 06:10:10 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 06/07/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had an episode where he experienced choking, and puking which he explained as a sensation that the generator was continually in magnet mode. He also reported a tingling sensation in his left arm associated with stimulation. X-ray images were reviewed and repealed no relevant information regarding the events. Additional clinic notes were received indicating that the patient reported that he experienced choking and shortness of breath sometimes. He felt scared during sleep. Patient complained of choking, shortness of breath, neck pain radiating left upper extremity. It occurred once in 10-15 minutes. In addition, he complained of pain in left chest and one episode of numbness in the left arm. The normal output current was disabled and magnet mode was left on. The physician notes that there was no abnormality on x-ray. The physician tried lowering the output current and adjusting the frequency, pulse width and duty cycle but the patient could not tolerate. Therefore the normal output current was disabled while leaving the magnet output current on. Patient has no symptoms when the device is disabled. No other contributory or casual events that preceded the reported events. The neurologist plans to refer patient to neurosurgery for a consult in regards to the electrode placement on the nerve. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695583


Title: Re: Arms
Post by: dennis100 on August 04, 2017, 06:11:18 AM
Device Problem No Known Device Problem
Event Date 05/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
A nurse reported that a patient began experiencing bruising on his left hand, difficulty moving his left arm, jerking in his left arm, and some pain. The patient's symptoms had reportedly begun after the patient's device had been programmed up to a certain level. X-rays were reviewed for the patient having these issues by a company representative and it was found that the patient's electrodes had been inverted during placement. No other anomalies were identified in the x-ray images. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6724226


Title: Re: Arms
Post by: dennis100 on August 04, 2017, 08:10:52 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 09/29/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient began experiencing intermittent pain at the neck site in the neck in 2014. The patient has since reported in 2017 pain in her neck and in her chest and armpit area too, and wants the battery explanted. Clinic notes for surgical referral provided that the patient is requesting vns to be removed as she is having pain at the site of vns implantation up into her neck. The device has been off since 2015 she states she is unable to move her left arm above her chin level. The notes provided they were unable to palpate chest wall to check for vns placement due to pain as the patient moves away and refuses further examination. 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=6695815


Title: Re: Arms
Post by: dennis100 on August 14, 2017, 03:03:56 AM
Model Number 102
Event Date 08/17/2011
Event Type  Injury   
Event Description
Reporter indicated a patient was experiencing severe pain at the vns generator site in the chest that was not related to stimulation. The patient did not want to stop vns stimulation. A referral to a surgeon was made, but no surgery date has been set as the surgeon ordered ct scans of the neck and neck. Surgery appears possible. A battery life analysis performed by the manufacturer yielded 4. 79 years remaining; generator end of service is not suspected. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had vns generator repositioning surgery performed on (b)(6) 2012. Since the vns generator was repositioned, the patient's pain has decreased significantly. The patient has been released from surgery back to the care of his neurologist.
 
Event Description
Reporter indicated the patient's vns was disabled on (b)(6) 2011 to evaluate for seizures. Replacement of the vns generator is not currently planned. The reporter does not know what to attribute the pain to. The pain was also occurring in the left upper extremity and jaw as well as the generator site. The patient's pain did improve somewhat with lowering the vns settings, but the response varies by appointment date.
 
Event Description
On (b)(6), 2011, a vns implanting surgeon's nurse reported that the vns pt was having their generator replaced due to increased seizures. The pt's programming history was reviewed and based on the pt's last setting of output=2. 75ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=3ma/magnet pulse width=250usec/magnet on time=60sec, the battery longevity tables revealed that the battery should last approximately around 2. 8 yrs from date of implant until eos. Although surgery is likely, it has not yet occurred. Good faith attempts for additional info from the physician regarding the pt's increased seizures have been unsuccessful thus far. When additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246510


Title: Re: Arms
Post by: dennis100 on September 08, 2017, 11:01:15 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/22/2017
Event Type  Injury   
Event Description
It was reported that the patient was scheduled for vns surgery for an unknown reason. Follow up with the patient's social worker revealed that the patient had contacted her primary care provider reporting stabbing pain at the surgery site and pain from the shoulder to the fingertip. The patient's husband had stated that the patient was doing okay with no seizures, no infection, and the vns was working. However, it was felt that the way the generator was positioned was putting pressure on a nerve, which was causing the pain. The surgeon was to reposition the device. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6774785


Title: Re: Arms
Post by: dennis100 on October 26, 2017, 12:52:33 AM
Model Number 102
Event Date 01/01/2013
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported that the patient's vns was explanted on (b)(6) 2015 due to the patient not wanting vns any longer and feeling that vns did not help her. Both the generator and majority of the lead was explanted. On (b)(6) 2015, the patient was doing well after explant. The nurse reported that the patient has a lot of psychiatric issues, so the patient thought vns was causing a lot of the problems. However, the nurse does not think that vns necessarily was and that it was likely more psych-related. The explanted devices have not been received by the manufacturer for analysis to date. Clinic notes dated (b)(6) 2015 reported that the presented to the clinic on (b)(6) 2014 with complaints of left shoulder and chest being "inflamed. " she was advised to go to nearest er for evaluation but the patient declined. At that time, the patient was still wanting the vns settings to be adjusted. The neurologist assessed that since the patient had non-epileptic seizures, there was no plan to revise the vns. However, due to the patient's complaints, the decision was made to explant the vns. The patient reported redness and warmth over the left chest intermittently and typically applied an icepack to the area to relieve the symptoms. The patient stated that she had symptoms related to the vns when it is on, including throat tightness and right shoulder pain. However although the device was off, the patient still complained of difficulty swallowing at times with right arm pain and swelling. Therefore at that time, the surgeon assessed that the events very likely may have not been related to vns.

Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.

Event Description
It was reported that the patient's the device was previously turned off due to painful stimulation. Explant may occur due to reasons unrelated to vns therapy. However, no known surgical interventions have occurred to date.

Event Description
Analysis was completed on the explanted products. In the pa lab, the device output signal was monitored for more than 24-hours, 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. Analysis in the analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Note that 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 anomalies were identified in the returned lead portion.

Event Description
On (b)(6) 2014, it was reported that the generator site is "extremely" swollen (described as the size of a pocket with four generators inside), which has been like this for about a year. It was confirmed that the swelling was not normal. The patient also reports periodic swelling at the incision site in the neck. Normal mode diagnostics were performed with showed dcdc = 3. It was noted that the patient recently had an mri and it was not turned off during the procedure. At this time, the patient would like it resolved since she is getting efficacy and would prefer to not have the device explanted. Surgery is likely, but has not occurred to date.

Event Description
Additional information was received stating that the vns patient¿s swollen generator site was causing the patient to experience painful stimulation. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3627213


Title: Re: Arms
Post by: dennis100 on December 06, 2017, 02:54:52 AM
Model Number 103
Device Problems Migration of device or device component; No Known Device Problem
Event Date 12/04/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient fell during a seizure that was caused by stress and hit her neck on a table. The patient reported that her generator migrated up towards her collarbone. The company representative saw that the generator was in a position that is commonly placed by surgeons. The patient did have a large bruise on her neck, from under the chin down to the bottom of the neck. Diagnostics were performed, which were within normal limits. X-rays were performed, and they showed that the generator was situated near the left armpit of the patient. The surgeon who placed the generator saw the x-rays, and he stated that the generator was in a place that would be considered normal for how he implants generators. The patient did have a circular bruise about 2 inches more medial than where the generator was observed to be in the x-rays. The location of the bruise is where the patient claimed that the generator was prior to the fall. The patient was referred for revision surgery to ensure the correct placement of the generator. No surgical intervention has occurred to date. Attempts for further information were unsuccessful to date.

Event Description
Clinic notes were received for the patient's appointment with the physician. The patient's generator was displaced and was painful, causing the patient to have reduced ability to mover her left shoulder and arm. The physician stated that the displacement was traumatic (due to a fall from the year before), and the pain in the left armpit and chest started the past few months. The patient also could feel the generator moving towards the axilla. The physician noted that the lead was not prominent before, but now he could see the lead clearly as it was being pulled on by the generator migration. The physician referred the patient for surgery to get a new generator and fix the migration. No surgical intervention has occurred to date.

Event Description
The physician did believe that the cause of the bruise was from the generator being displaced laterally from the fall. Pocket revision surgery was planned due to the migration of the generator. However, the patient saw her neurologist again instead of going to see the surgeon. The neurologist decided that the generator was in a normal position, which was previously confirmed by the surgeon, and would not require surgery.

Event Description
The patient had generator replacement surgery due to migration/pain. The device was explanted by the hospital. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5337448


Title: Re: Arms
Post by: dennis100 on December 09, 2017, 01:39:50 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 11/09/2016
Event Type Injury
Event Description
It was reported that a physician disabled a patient's generator because the patient was experiencing "too much chest wall pain with radiation into her left arm. " the physician programmed the normal output current off, but left the magnet output programmed on. No additional intervention has been taken for the patient's pain. The painful stimulation started about a month prior to the report. Diagnostics were within normal limits at the patient's last two office visits. The patient's settings were adjusted at the last office visit, so the diagnostics were performed after the painful stimulation began. Later follow-up was received (b)(6) 2017 from the surgeon's office that the patient was referred by the neurologist for explant of the device as the patient seemed unwilling to accept the side effects. 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=6996132


Title: Re: Arms
Post by: dennis100 on December 17, 2017, 01:55:56 AM
Model Number 102
Event Date 04/22/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received for a patient's generator replacement referral which indicated the patient is experiencing an increase in seizures. The patient's wife stated the patient used to have seizures every 4-6 weeks. Currently patient is having seizures about 2 times a week. The patient states seizures occur closer together when he has them. The patient's wife states he has been unable to sleep well due to the pain in his arm and shoulder and thinks that the lack of sleep may be causing the increased seizure activity. Systems diagnostics were reported to have been taken on (b)(6) 2016. Additional relevant information has not been received to-date.

Event Description
Follow-up from the physician was received indicating the patient is still experiencing an increase in seizures and has been referred for battery replacement as the generator battery status showed intensified follow-up indicator=yes. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5677106


Title: Re: Arms
Post by: dennis100 on December 20, 2017, 08:34:14 AM
Model Number 106
Event Date 05/06/2016
Event Type Injury
Event Description
It was reported on 07/08/2016 that, that patient had surgery that day and because her generator had migrated. The generator was anchored securely with multiple stitches in hopes to prevent further vns pocket issues. Notes were received dated (b)(6) 2016 from intraoperative report. In the notes there is no mention of issues with vns and no mention of the type of suture used to secure the generator.

Event Description
Further information was received through operative notes dated on which the migration was corrected. The notes stated that the patient had surgery due to the mobility of the generator which has caused discomfort and concern for erosion of the generator through the skin. The patient had described the movement as flipping, and during the surgery, the generator was found to have flipped. It was noted that the silk suture used to anchor the generator had pulled out from the underlying tissue. The generator was repositioned. Scar tissue in the chest area was identified and the generator was anchored to this tissue. Additional silk sutures were passed through the scar tissue to the generator to provide more security. No further information has been received to date.

Manufacturer Narrative
(b)(4).

Event Description
It was reported on 05/20/2016 from the patient that her generator was just placed on (b)(6) 2016 and is now moving around in her chest. She can slide it back and forth and is causing a lot of pain along her scar line on her chest when she moves her arm. She stated it started about a week or two prior. Follow-up from the physician showed that there was no trauma or manipulation that may have caused the generator to move. It was stated that a non-absorbable suture was not used to secure the generator to the fascia during initial implantation. However, it was also stated that the patient previously had a model 103 which was replaced with the larger model 106 which required enlargement of the previous pocket thus causing the movement. The patient is planned for revision of the generator with plan for sub-muscular placement although this has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5724621


Title: Re: Arms
Post by: dennis100 on December 22, 2017, 03:35:03 AM
Model Number 102
Event Date 05/01/2016
Event Type Malfunction
Event Description
It was reported that the patient started experiencing pain at the generator site recently. The pain was not reported to be associated with stimulation. The pain is however causing the patient to have panic attacks which lead to increased seizures. Patient was provided a neurologist contact information and asked to follow up with the physician regarding the concerns. However, no additional relevant information was received.

Event Description
Patient underwent explant surgery due to shoulder and neck pain. The physician stated that the patient demanded it be removed due to shoulder and neck pain. A portion of the lead was cut but the electrodes remain implanted. No other relevant information was received.
Manufacturer Narrative

Event Description
Additional information was received that the patient is still having pain in his arms/legs and generator site, but this pain is present even when the device is "off. " patient has held the magnet up to his generator for 5 minutes at a time t temporarily disable stimulation, and experiences worse pain during the disablement. The pain often wakes him from sleep and he wakes up in a sweat. Patient said that a doctor has mentioned that this could be related to anxiety, but it has not been confirmed. Additional information was received that the patient's vns settings were programmed at unusual setting of 30 seconds on time and 150 minute off time. The reason patient was feeling pain during the stimulation was because the settings were too high and there was a long break in between. The physician adjusted the patient's settings to a normal duty cycle and reduced the output current but the settings and diagnostics were not provided. Seizure patterns will be evaluated on an ongoing basis now that the vns has been programmed appropriately.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5704559


Title: Re: Arms
Post by: dennis100 on December 28, 2017, 02:45:54 AM
Model Number 106
Event Date 08/18/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
The patient underwent a battery replacement on (b)(6) 2016. At a follow-up visit the patient reported having pain at the incision site in his left chest. The paint also could not raise their arm due to the pain. There was flushing at the incision site. The doctor prescribed pain medication and antibiotics on (b)(6) 2016. The patient was doing much better as of 08/29/2016. A design history record review was performed on (b)(6) 2016. The review indicated that the generator passed all test and was sterilized. The expiration date of the sterility is (b)(6) 2018. The patient's symptoms were still present but improved as of 09/07/2016. No other relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5954267


Title: Re: Arms
Post by: dennis100 on December 29, 2017, 02:05:08 AM
Event Date 08/01/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on 08/17/2016 from the patient's mother that she was concerned that her daughter's generator battery may be depleted due to recent reports that she has had more seizure events. It was reported that this has only been occurring this month. The patient has been having a feeling of "pins and needles all over her head, arms, and legs" which also leads her mother to fear that her seizures may be returning. No additional information has been received to date.

Manufacturer Narrative
Supplemental mdr #2 inadvertently omitted information that changed the file from a malfunction to serious injury. Information was known prior to submission that intervention was taken for the adverse event.

Event Description
The patient underwent battery replacement on (b)(6) 2016 for battery depletion. The product was discarded after surgery is not available for return.

Event Description
On (b)(6) 2016 it was reported that the patient had not been seen since (b)(6) 2014. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5935884


Title: Re: Arms
Post by: dennis100 on December 29, 2017, 02:06:17 AM
Model Number 106
Event Date 08/12/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
The patient had her vns generator explanted on (b)(6) 2016. The explanted generator has not been returned to the manufacturer to date. Follow up communication with the explanting surgeon determined that, in his medical opinion, there was no indication of an underlying infection or site reaction. He believed the patient perceived the device as being uncomfortable. The surgical intervention taken was not to preclude a serious injury. There was no trauma or other external factors that were contributing to the reported symptoms. No additional pertinent information has been received to date.

Event Description
The explanted generator was reported to have been discarded following the explant surgery. No additional pertinent information has been received to date.

Event Description
Additional information received showed that the patient had her vns removed due to pain from the size of the generator. Clinic notes showed that the device had also migrated from its original implant location prior to removal. No additional pertinent information has been received to date.

Event Description
It was reported that the patient was experiencing pain where her vns implant is in the chest and down her left arm. The vns generator was also reportedly protruding from her skin. She had passed out at the time this started, and she was also experiencing a low-grade fever. Follow up with the surgeon's office showed that the patient came in for an appointment, and surgery was planned to remove her vns. It was reported that this was upon patient request on not wanting the vns anymore. However, insufficient information was given on what role the reported symptoms had in the decision to explant the device. Surgical intervention has not occurred to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5939462


Title: Re: Arms
Post by: dennis100 on January 06, 2018, 04:24:40 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 10/06/2004
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received and stated that the patient underwent vns surgery of her first implant but she had pain in the left axilla and arm. Therefore, the generator was relocated below the left clavicle and she continued to have problems with pain. The generator was then placed below the pectoral muscle without difficulties. The notes state vns stimulator insertion 2004/2006/2008 which the 2006, 2008 are likely the relocation surgeries. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7076570


Title: Re: Arms
Post by: dennis100 on January 06, 2018, 04:25:30 AM
Model Number 101
Device Problem No Known Device Problem
Event Date 11/19/2002
Event Type Injury
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


Title: Re: Arms
Post by: dennis100 on January 07, 2018, 03:31:20 AM
Model Number 302-20
Device Problem Fracture
Event Date 12/06/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient experienced pain in the neck the chest and the left arm. The device was found to have high impedance. 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=7134281


Title: Re: Arms
Post by: dennis100 on February 01, 2018, 04:14:52 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2012
Event Type Injury
Event Description
Patient experienced ¿choreoathetoid movements¿ starting approximately in (b)(6) 2012. These are reported to be arm twitch movements. The neurologist stated that these are not seizures. The neurologist believed that these movements were related to the stimulation but were not associated with the stimulation (stimulation on time) because the movements did not coincide with the ¿on time¿ programmed on the vns. The device was not disabled to preclude a serious injury.

Event Description
It was reported that the patient had the vns device disabled for over 5 years now. The device was disabled due to an increase in "athetoid" style of seizures after generator replacement. The patient had an arm swing that was much more notable after device replacement and so the patient's device was disabled. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6284845


Title: Re: Arms
Post by: dennis100 on March 10, 2018, 02:38:22 AM
Model Number 104
Device Problem No Known Device Problem
Event Date 12/23/2017
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Report received that a patient experienced sharp pain in her neck with stimulation that started after she walked through security scanners at departments stores. The patient also reported feeling continuous stimulation for awhile after walking through these scanners. The patient did not feel as if her magnet stopped the feeling of stimulation. The patient was admitted to the er where diagnostics were taken. The results were within normal limits. The er staff was instructed to decrease the vns pulse width by the patient's neurologist. After this adjustment, the patient reported having painful stimulation in her arm that radiated from the shoulder. The next day, the er staff reported that the patient might have had brachial nerve issues related to vns which contributed to the arm pain. The patient was put on steroids but the patient continued to report having painful shocks up her neck and arm. The patient was admitted a few days later for a battery replacement. This replacement had been planned as prophylactic before the patient reported painful stimulation, but the surgeon indicated that he had hoped the replacement would resolve the painful stimulation. Before this replacement, the patient continued to report painful arm stimulation, but also reported that she experienced painful stimulation in the chest. Diagnostics were again taken before replacement and results were within normal limits. After the replacement, the surgeon noted observing a lot of dense scar tissue around the leads where they connect to the generator. Further information was received that the patient continued to feel painful stimulation after the new generator was implanted. The patient's neurologist decided to disable the device in hopes that the nerve would "settle down". X-rays were reportedly taken and looked "good" according to the neurologist. The patient continued to report painful stimulation even with the device off. The neurologist reported that the patient had psychogenic issues and may have reported this painful stimulation for attention. The explanted generator was returned to the manufacturer for analysis, but analysis has not been completed to date. Both the replaced generator and newly implanted generator passed all quality inspections and electrical tests prior to being released for distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7251316


Title: Re: Arms
Post by: dennis100 on March 10, 2018, 02:39:29 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 12/27/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported the patient had her device removed because the patient felt that she had left chest and arm pain from the device. The explanted devices were discarded after explant and are not available for analysis. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7245738


Title: Re: Arms
Post by: dennis100 on March 11, 2018, 01:39:56 AM
Model Number 103
Event Date 03/19/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002


Title: Re: Arms
Post by: dennis100 on March 19, 2018, 01:56:28 AM
Model Number 302-20
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, the clinical specialist reported that she reviewed the patient's chest and neck x-ray report and they were abnormal with a possible disruption of the lead in the left neck. The physician recommended that a soft tissue neck report be performed. The neos flag was no for diagnostics and results of both the normal mode and system diagnostics were within normal limits. The soft tissue neck report indicated that the lead was intact. It was noted that each time diagnostics were performed, the system diagnostic's dcdc=3 and the normal mode dcdc=2 consistently. The patient has been experiencing shortness of breath within the last 6 months - 1 year and has had pain that runs down her arm and numbness when firing that also runs down her arm. There is no increase in coughing and the seizures are still monthly. The nurse practitioner had said that they ruled out cardiovascular and pulmonary issues with the shortness of breath. A battery life calculation was performed which showed 6. 37 years remaining until eri=yes. A/p and lateral x-ray images of the neck dated (b)(6) 2012 were received by the manufacturer. The generator was not able to be visualized due to the views in the x-rays provided. Therefore, whether or not the lead pin was fully inserted into the header of the generator could not be assessed. The electrode placement appeared to be normal and no lead discontinuities or acute angles were seen in the visible portions of the lead body. The patient later reported on (b)(6) 2012 that the device is causing her pain on and off throughout the day for about 5-6 plus hours a day. The patient was asked to be seen again regarding an evaluation of medications and vns. Good faith attempts for further information from the physician have been made but have been unsuccessful.

Event Description
On (b)(4) 2012, additional x-ray images were received, however these were the same x-ray images that had been provided by the physician earlier.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2794888


Title: Re: Arms
Post by: dennis100 on March 29, 2018, 01:29:13 AM
Model Number 102
Event Date 05/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the surgeon's office that the patient had generator replacement surgery on (b)(6) 2012. However, attempts for product return have been unsuccessful to date.

Event Description
Attempts for product return were unsuccessful as the explanting facility indicated that they could not locate the explanted generator, so it was assumed by the facility that the device was discarded.

Event Description
Clinic notes dated (b)(6) 2012 were received by the manufacturer and reported that the patient had been experiencing lue/lee twitching episodes for the prior six months that last for about three to four minutes with no impairment of consciousness. In the notes dated (b)(6) 2012, it was indicated that the patient usually had mix types of seizure including grand mal, petit mal, partial seizure. After vns placement, he has not had any grand mal seizure in the past five years. Currently, he describes the seizure as arm, eye twitch (early sign). These events were now happening about once a week. Follow-up with the treating physician was performed. He reported that the patient's new seizure type is not believed to be related to any vns problem, and his vns seems to be fully functional. However, the manufacturer battery life calculation determined that as of november he had less than half a year left on his battery. That fact, combined with the fact that since then i have increased his settings to 2. 0ma on (b)(6) 2012, which will most likely lead to an even shorter battery life, led the physician to believe that it is best to replace the generator prophylactically. The physician also reported that he has no way to know if the increased seizures are related to vns. The patient feels the vns stimulation, and the interrogation says that it is not near end of service. Therefore, the physician stated that he has no reason to suspect that the vns is not functioning properly, although perhaps the battery is "just low enough to cause an increase in seizures. " although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874197


Title: Re: Arms
Post by: dennis100 on April 04, 2018, 01:10:29 AM
Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
Event Description
Additional information was received which indicated that the voice alteration was occurring with stimulation, there were no change in medication, and the increased impedance was seen on the vns device diagnostics, but there were no visible lead fractures in x-rays. There was no patient manipulation or trauma that might have caused the lead impedance. After the full revision the patient's seizures are now gone. The patient's settings on (b)(6) 2013 are output current= 0. 25 ma/ frequency= 15 hz/ pulse width= 130 usec/on time= 30 sec/off time= 3 min / magnet output current= 0. 5 ma/ on time= 60 sec/ pulse width= 250 usec. The device history report for the 302-20 sn (b)(4) was reviewed. No unresolved non conformances were found.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported through clinic notes received on (b)(6) 2012 that the patient had high impedance upon interrogation of her vns device on (b)(6) 2012. It was noted that the patient was last seen on (b)(6) 2012. The patient had been experiencing pain and soreness over the chest during stimulation which started on (b)(6) 2012 when the patient went to the er because she was experiencing burning in the neck. On (b)(6) 2012 it was stated that the patient had a fall approximately 1 week prior and the physician was uncertain if it was related to the patient's pain. At that time the patient described "mouth vibrations", chest pain near the generator radiating to her teeth head and arm with electrical qualities. Per the physician, an x-ray at that time did not show any gross lead fractures. On (b)(6) 2012 the pain was said to radiate to ear when the device stimulates and it was stated that the patient had discomfort when lifting her left arm. When the device was disabled the discomfort was gone. It was also indicated that the magnet had become more painful recently. Additionally it was noted that the patient had been experiencing an increase in seizure frequency. It was indicated that the patient usually experiencing 4-5 seizures per month when sleepy, however she had started experiencing 2-3 per month during the day as well as an increase in staring spells. The patient was referred for and underwent a full revision on (b)(6) 2012. A review of available programming history for the patient's generator was performed and diagnostic results in (b)(6) 2012 were within normal limits. Attempts for additional information and product return are in progress.
 
Event Description
An implant card was received on (b)(6) 2013 indicating that the reason for the replacement was due to an adverse event. The impedance from the date of surgery was not provided. Per the hospital's policy the hospital will not return explanted devices without a signed consent form and the patient, however the physician's will not ask for the signed release; therefore the product will not be returned. Attempts for additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2897410


Title: Re: Arms
Post by: dennis100 on April 07, 2018, 01:09:47 AM
Model Number 10X
Event Date 12/29/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient had shown symptoms of autoimmune process which is appeared with subfebrile temperature, pains in joints etc, but the locus with generator is absolutely intact. The event began on (b)(6) 2012. The symptoms included high temperature, pain in the right knee and left elbow joints while moving, and swollen, hot joints. The patient was hospitalized with anti-inflammatory therapy. The antibiotics were applied successfully, and the patient left the clinic. The high temperature and pain began again on (b)(6) 2013. The locus of generator was intact. Anti-inflammatory therapy was continued. The number of seizures was increased almost to the pre-vns baseline (after vns implant, the patient experienced a 50% seizure elimination). Doctors did not determine the clear causes of the situation, but pediatricians tended to relate it to vns. The patient's heredity is free of distinctive features. The mix of antiepileptic drugs and vns parameters were not modified. The previous week, the patient left the clinic with satisfied status. The diagnosis was juvenile rheumatoid polyarthritis. The rheumatoid tests are negative. Cytostatics are not prescribed because the diagnosis is disputable. The generator was never disabled. No diagnostics are available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2976156


Title: Re: Arms
Post by: dennis100 on April 15, 2018, 12:36:03 AM
Model Number 304-30
Event Date 12/10/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that per the physician's notes, the patient's electrodes and generator were removed but the surgeon felt that there was not enough space to reimplant new electrodes due to scar tissue and therefore did not reimplant the patient. It was also reported that the explanted generator would be returned to the manufacturer for product analysis. The explanted generator was returned to the manufacturer for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed.
 
Event Description
Good faith attempts for the return of the explanted products were unsuccessful.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for the lead confirmed device met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was reported that the patient's lead is broken and was referred for revision surgery. Because the patient has shunted hydrocephalus and no recent imaging, it was stated that prior to surgery a brain mri would be performed to make sure the patient's ventricles aren't enlarged. Clinic notes were received dated (b)(6) 2013 revealed that the week prior, the patient reportedly had 30 "small" seizures on the school bus. The patient normally has about 2 generalized tonic-clonic seizures per month and 1-2 smaller tonic-clonic seizures that affect upper extremities only. The patient's grandmother noticed that the patient has recently started looking upward and the left with left eye deviation and left arm flexion during the smaller seizures. The physician noted that there is no significant change on seizure amount as per family members. High impedance was noted that day during interrogation and "a broken wire was detected". The patient's settings were noted to be output=1. 75ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=0. 8min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. Clinic notes dated (b)(6) 2012 indicate that for the last two weeks, the patient is presenting with sporadic jerking movements in the right shoulder during the night and the patient's guardian recounts a different type of seizure involving a shaking of the upper extremity that lasts one to two seconds and results in postictal dizziness. The patient underwent a full revision surgery on (b)(6) 2013. The hospital reported that the lead would not be returned to the manufacturer for product analysis. Attempts for the return of the explanted generator are underway but it has not been returned to the manufacturer to date. Good faith attempts for further information from the physician have been unsuccessful. The manufacturing records for the lead were reviewed and device met all specifications prior to distribution.
 
Manufacturer Narrative
Additional information was received which changes the event date from what was originally reported.
 
Event Description
Product analysis on the explanted generator was completed on (b)(6) 2013. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The generator¿s internal memory showed that the impedance value increased from 1346 ohms to 10,000 ohms on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2985124


Title: Re: Arms
Post by: dennis100 on April 18, 2018, 01:20:27 AM
Model Number 302-30
Event Date 03/11/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance on systems and normal mode diagnostics. The physician disabled the patient at a later appointment. Patient denies any manipulation or trauma. The patient has reported pain in her arm and neck for 3 weeks prior to the high impedance being visualized. It is unknown if the pain is occurring with stimulation or if it is related to the high impedance. The patient was referred for surgery. Surgery is likely but has not occurred to date. Good faith attempts for additional information have been unsuccessful to date. The physician responded to attempts but did not address the question and only provided some programming history. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.
 
Event Description
Additional information was received that the patient had a generator and lead replacement and has been turned back on. Product return attempts have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3042434


Title: Re: Arms
Post by: dennis100 on April 24, 2018, 01:11:05 AM
Model Number 103
Event Date 04/10/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 indicated that this vns patient had an event that was not typical that involve the same jerking motion but it did not cluster. The patient's seizures typically occur in clusters. During the events, the patient will quickly jerk her arms and legs, typically pulling them in. Sometimes only one arm will pull upward and this can be at slow rhythm or quick, rapid jerks. A cluster of these events will last 7-10 minutes resolving in return to baseline. The second type of event has only occurred twice and involved the same extremity jerking but the patient holding her breath during the jerk. This event occurred three weeks prior to for the first time and lasted 7-10 minutes, like the jerking events. The third type of event involved staring straight forward, possibly slightly upward, while she is non-responsive. This occurred two weeks ago while the patient was hospitalized. The event last 40 seconds and involved arrested behavior including sucking on her pacifier. The device was reportedly at end of service no longer providing a charge. These events had increased over the last few months, likely correlating with battery failure on the vns. The patient was referred for generator revision. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.
 
Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the patient underwent a generator replacement on (b)(6) 2013 due to end of service. The explanted generator was returned for product analysis on (b)(6) 2013. Product analysis on the generator was completed on (b)(6) 2013. Review of the data indicated that the pulse-disabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118624


Title: Re: Arms
Post by: dennis100 on May 04, 2018, 01:24:44 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 06/19/2017
Event Type  Injury   
Event Description
It was reported by a vns patient that he got a new device and whenever he moves his arm his device moves around. He stated that this has never occurred with any of his previous devices and that he is in discomfort because of the movement of the device. The patient stated there were no traumatic injuries that could have resulted in the generator becoming loose and moving around. It was later reported that the patient was experiencing discomfort with the device and the patient feels the generator is too big. The patient was referred for surgery to receive a smaller device. 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=7472222


Title: Re: Arms
Post by: dennis100 on May 05, 2018, 12:33:56 AM
Model Number 304-20
Device Problem No Known Device Problem
Event Date 10/07/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing pain in the chest area that goes down her arm, neck pain, tingling sensation in their arms, headaches, back pain, right shoulder pain, and paraesthesia in the upper and lower extremities. Due to the pain, it was also reported that the patient was experiencing sleep disturbances. Device diagnostics were performed and reported to be normal limits. Per the physician's assessment, the cause of the events is due to the surgeon nicking the nerve during surgery. The patient was referred for surgery due to the pain. No additional relevant information has been received to date. No surgical intervention is know to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7445025


Title: Re: Arms
Post by: dennis100 on May 06, 2018, 01:39:32 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 12/14/2017
Event Type  Injury   
Event Description
It was reported that the patient was feeling pain in her chest and could feel her device move when she moved her arm. The patient was referred for generator repositioning surgery due to the pain and migration. The patient had surgery, and the generator was still sutured down in place from the implant surgery. The surgeon identified a mass of fluid around and below the generator. The seroma was drained, and the surgeon prescribed antibiotics. The generator was left in place, and the lead was not disconnected. Diagnostics were within normal limits, and the settings were not changed. The surgeon reported that the seroma caused an infection at the generator site. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7404008


Title: Re: Arms
Post by: dennis100 on May 12, 2018, 01:28:49 AM
Model Number 304-20
Event Date 10/04/2013
Event Type  Malfunction   
Event Description
Clinic notes were received for the vns patient office visits with his neurologist. Notes dated (b)(6) 2013 indicate that the patient had several breakthrough seizures since his last office visit with the most previous one occurring on (b)(6) 2013. The patient had one seizure at school consisting of generalized shaking of the extremities which appeared to slow or stop after magnet mode stimulation was activated. The patient's mother stated that the patient was having seizures throughout the night due to his drowsiness during the day. The patient continued to feel dizzy especially with physical activity. The patient had 2-3 head drops since his last office visit that occurred after having seizures while sleeping. The patient was able to feel when he was having a seizure and used the magnet frequently. The patient had different types of seizures over the past year: head drops lasting 10 seconds; generalized twitching of his extremities lasting 10-60 seconds; and clonic seizures lasting 15-30 seconds. The neurologist stated that overall the patient had an improvement sinc vns implant as the duration of his seizures had decreased significantly. The patient's device settings and medication was increased during the office visit. The neurologist stated that patient's wrestling with his siblings may have contributed to the high impedance observation. X-rays were taken during the office visit and were reported by the physician to be unremarkable. The patient's device was not disabled following the high impedance observation. Notes dated (b)(6) 2013 indicate that the patient had another seizure that lasted approximately one minute since his last office visit. The patient's device was tested during the office visit while the patient was sitting, lying, and turned his head. Diagnostic results from all the positions showed normal lead impedance. The neurologist stated that a microfracture may be a possible reason the high impedance observation at the previous office visit. Notes dated (b)(6) 2014 indicate that the patient had several seizures the week prior to his office visit. The patient's seizures were occurring at night. The patient's mother stated that the seizures would last approximately 10 seconds although she did not witness them. It was reported that magnet mode was activated but did not help in stopping the seizures. The patient's device had previously helped the patient reduce the duration of his seizures and postictal phase. The patient's medication was increased during the office visit. The patient's device was tested during the office visit and diagnostic results showed high lead impedance (impedance value >= 10,000 ohms). The patient's device was subsequently disabled. Notes dated (b)(6) 2014 indicate that the patient had three seizures in the past four weeks. The seizures were much milder and consisted of shaking of his entire body for 30-40 seconds. The patient also had 1-7 head drops that occurred throughout the day. The patient's device was tested during the office visit and diagnostic results showed high lead impedance. The patient's medication was increased during the office visit. Further follow-up revealed that the patient did not respond well to vns and the patient's seizures may be due to a combination of factors. X-rays were taken and were reported by the physician to be unremarkable. The x-rays will not be provided to the manufacturer for further review. The patient was seen prior to the his office visit in (b)(6) 2013 and diagnostics showed normal device function at the time. The patient was referred for replacement surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that during an office visit on (b)(6) 2014, the vns patient¿s device was tested at several positions and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently programmed off. X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
On (b)(6) 2013 it was reported that the patient was seen by the physician that day and upon running diagnostics, high impedance (impedance value greater than 6200 ohms) was observed. This was when the patient was in the upright position. The physician had the patient lie down and ran diagnostics again, which showed the device was okay with impedance value of 3200 ohms. The patient was again re-positioned into an upright position. Diagnostics performed while the patient was in the upright position again showed high lead impedance with impedance value greater than 6200 ohms. It was confirmed that the patient had no trauma, no falls, and no manipulation. The patient went to have x-rays taken and it was stated that the vns device would be disabled to 0ma that day. Additional information was received that the patient's mother reports that the patient had an increase in seizures over the last two weeks, but not above baseline levels. The x-ray results indicated that there was no fracture. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3443991


Title: Re: Arms
Post by: dennis100 on May 21, 2018, 01:34:04 AM
Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. 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) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, 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 generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248


Title: Re: Arms
Post by: dennis100 on June 08, 2018, 03:34:29 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing painful stimulation and pressure in the chest, shortness of breath, and left arm pain. The diagnostics were found to be within normal limits. It stated that the patient was experiencing cardiac pain symptoms, but the physician did not think they were related to the vns. The vns parameters were programmed at various settings in an attempt to replicate the pain described by the patient. The patient was referred for a complete cardiac checkup with a holter monitor in order to rule out any relationship between his chest pain and vns. The patient requested removal as he had found the generator uncomfortable and the area was sore due to being bumped regularly when playing with his children. The patient underwent vns explantation surgery. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544133


Title: Re: Arms
Post by: dennis100 on June 09, 2018, 02:22:17 AM
Model Number 103
Device Problem No Known Device Problem
Event Date 04/14/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to feeling constant pain at her generator site for an hour, which she believed to be continuous stimulation from the device, and she was also experiencing constant tingling in her arm. The physician stated that there were no reported traumatic events prior to the constant pain. The physician was educated on how to use the magnet to disable the device until it could be communicated with. It was reported later in the same day that the patient was feeling painful stimulation every 5-7 minutes. The patient had reportedly seen her neurologist and described her pain, but nothing was changed and the pain got worse so the patient went to the emergency room. The hospital staff called the next day to report that the patient was still having continuous stimulation, but they had not been using the magnet to disable the device as instructed. A company representative was able to communicate with the patient's device, and system diagnostics were within normal limits. The patient stated that she felt the stimulation when diagnostics were performed. The neurologist had come in the night before and programmed the device off. Since the device was programmed off. The painful stimulation resolved immediately after the device being programmed off. The patient had generator replacement surgery. The device has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7504920


Title: Re: Arms
Post by: dennis100 on June 09, 2018, 02:22:50 AM
Model Number 302-30
Device Problem Low impedance
Event Date 11/01/2004
Event Type  Malfunction   
Event Description
It was reported by a nurse in the patient's group home that the patient was complaining that he felt electricity through his body on and off throughout the day. The patient also reported that his left arm felt heavy and numb. Follow up with the patient's neurologist revealed that the neurologist was unaware of the events. During review of the manufacturer's programming history database, it was revealed that a dcdc code of 0 was present during system diagnostics. The dcdc code, while possibly within normal limits, and the reported events are possibly indicative of low impedance. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7529711


Title: Re: Arms
Post by: dennis100 on June 09, 2018, 02:23:29 AM
Model Number 106
Device Problem No Known Device Problem
Event Date 03/13/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's mother reported that her son was implanted last year and after the surgery he was not able to walk, lost control of his upper and lower limbs, and at times could not hold his posture. It was explained he continues to need help walking as the patient is very ataxic. The patient also sometimes needs help feeding himself and he no longer talks, walks independently, and interacts less. The patient was previously diagnosed with autism, but it has declined significantly since the vns procedure. It was noted the neurologist completed testing of the system to verify everything was working correctly, and it was. No one had an explanation for the patient's decline. It was also stated that the patient has been diagnosed with tuberous sclerosis which can contribute to developmental delays including physical ones. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7493765


Title: Re: Arms
Post by: dennis100 on July 06, 2018, 08:37:52 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing pain around the vns and going down her arm when lifting. The surgeon prescribed anti-inflammatory for a weeks and the pain did not resolve. The patient was referred for prophylactic vns replacement surgery. Follow up with the physician revealed that the patient reported no trauma to the area. No cause for the pain was found. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7577968


Title: Re: Arms
Post by: dennis100 on July 06, 2018, 08:38:24 AM
Model Number 304-20
Device Problem No Information
Event Date 06/04/2018
Event Type  Malfunction   
Event Description
It was reported that this patient was referred for replacement due to lead issues and generator migration. It was noted that the device moves in their chest, and every time it moves, the patient gets a shock that travels down his arm. Diagnostics were taken several times and were all within normal limits. Additional information was received from the patient's surgeon that a silk, non-resorbable suture was used to secure the generator to the chest wall during the patient's previous implant. It was then stated that it looked like the suture was no longer attached to the chest wall indicating that the generator was no longer secured. Additional information was received from the neurologist¿s office stating that the patient¿s mother had stated that the patient's shocking sensations had occurred a long time ago and he was no longer experiencing any issues. The lead underwent product analysis and two sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. No discontinuities were identified within the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The surgery facility is a no return site. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7645903


Title: Re: Arms
Post by: dennis100 on July 15, 2018, 03:20:03 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 04/19/2016
Event Type  Injury   
Event Description
The patient later reported that when her neck it flexed forward, or her hands are on her chest, the device seems to stimulate. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported by the patient, it took her 5 hours to come out of anesthesia after vns implant surgery and that she had jerking and ataxia along with an increase in seizures. The increase in seizures and ataxia were later possibly attributed to abruptly stopping xanax. The patient was given gabapentin for the jerking. The patient also noted it took her a week to get strong enough to walk without a walker. The patient also stated she has a drop in her gait, abnormal movements, slurred speech, and flailing extremities while she was in the hospital. She stated she had been admitted due to seizures. The patient was later seen by her physician and was doing better and was able to walk in sunlight without sunglasses and without jerking and headaches. The patient also mentioned having swallowing issues. It was also noted the patient was able to tolerate the magnet swipes after the 3rd swipe, but it was unknown what tolerability issues were noted with the first 2 swipes. Lastly, the patient noted she can see the lead protruding (still under the skin) when she wakes up in the morning for a few hours before it goes back to flush with her skin. Attempts for additional information have been made but have been unsuccessful to date.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #02 mfr. Report.
 
Event Description
The patient later reported she has had a lot of pinching around the axilla of the left breast incision, and displacement of the device upon moving around in bed. Attempts for additional information have been unsuccessful to date.
 
Event Description
Further information was received that the patient was experiencing an exacerbation of symptoms with vns including sleeping disturbances, ambulatory difficulties, and dysphagia. It was also reported that these symptoms started after her device was programmed back on in june 2017, indicating it had been previously turned off. No other relevant information was received from the patient's physician.
 
Event Description
The patient later reported that she is having an increased sensitivity with clonic jerks, poor large muscle control upon movement, blurred vision, slurred speech, headaches, and a longer recovery time after seizures. She stated she was also having increased light sensitivity. The patient thinks some of the symptoms may be related to medications, but it is not confirmed. She did note that she had a 5 day veeg. She was taken off of 2 of her medications and had a decrease in symptoms of ataxia and stated the majority of her symptoms were medication induced. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician stating the patient's symptoms were related to medications. Additionally, the physician did not believe the patient's pinching sensation was related to vns and no interventions have been taken due to the reported pinching sensation.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Further information was received that the patient believed she had new issues with vns. Specifically, she complained of having "charlie horses in throat" on the left side vocal cord when she yawned or opened her mouth to sing. She also reported that she has experienced pain in the chest that extends down to her left arm. This pain was reportedly not constant (it "comes and goes"). The patient also reported having continued issues that were previously reported such as dysphagia, erratic stimulation, speech impediment, and ambulatory issues. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649


Title: Re: Arms
Post by: dennis100 on July 22, 2018, 02:19:09 AM
Model Number 101
Event Date 06/11/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6), 2012 clinic notes dated (b)(6), 2012 were received from a vns treating physician. Review of the clinic notes revealed that the patient¿s mother stated the patient was recently hospitalized from (b)(6), 2012- (b)(6), 2012 due to a stroke and a hole in her heart told to her by cardiology. No outpatient cardiology has been set up at this time per the patient's mother. The patient has residual speech difficulty and right upper and lower extremities weakness. The patient has been provided with speech, occupational, and physical therapy. The patient is currently on asa 81mg per day. No new stroke-like symptoms have been reported since then. The patient's blood pressure was noted to be 124/76. The patient's assessment includes stroke/cerebral thrombosis with cerebral infarction. Attempts for further information have been made to the physician but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2665067


Title: Re: Arms
Post by: dennis100 on August 14, 2018, 12:47:40 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/26/2018
Event Type  Injury   
Event Description
Report received that a pain had pain that radiated from her generator site to her neck, face, and right side of her head. This pain was reportedly worse upon exertion but also occurred while sitting. The pain had reportedly occurred for three weeks with a few severe episodes. The patient also reported feeling fatigued. The patient reportedly went to the hospital during one severe painful experience where cardiac work was done. Although the results were negative, there was reportedly some bradycardia. The physician reported that the vns was checked and the settings were "low". The impedance was also reportedly checked and was found to be within normal limits. The physician elected to disable the device but indicated he would refer the patient for follow-up with a surgeon for reevaluation of other etiologies. No additional relevant information has been received to date.
 
Event Description
Further information was received that despite the generator being disabled, the patient continued to experience the previously reported adverse events, specifically pain. It was stated that the paint occurred in the generator area and was associated with left upper extremity pain and some numbness. Because of this, the patient requested both the lead and generator be removed. The physician reportedly advised that the pain the patient was feeling was likely not from vns, but a definitive assessment was not made. No surgical intervention has occurred to date. No additional relevant information has been received.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997


Title: Re: Arms
Post by: dennis100 on September 23, 2018, 03:03:39 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2015
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The funeral home indicated that the device was explanted by the medical examiner and would be returned for analysis. The medical examiner's office indicated that the autopsy is pending, but would be provided when completed. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The autopsy finding were listed as clinical history of rett syndrome with a history of uncontrolled seizures, musculature atrophy of extremities, scoliosis; pulmonary congestion/edema; history that the decedent was found unresponsive in a prone position in bed. The conclusion was noted to be that the decedent died as a result of a seizure disorder associated with rett syndrome. The manner of death was listed as natural.
 
Event Description
Analysis of the generator was completed on (b)(6) 2015. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on (b)(6) 2015. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, aluminum, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4772129


Title: Re: Arms
Post by: dennis100 on November 10, 2018, 03:43:10 AM
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/13/2018
Event Type  Injury   
Event Description
It was reported that the patient was scheduled to have the vns removed. Investigation determined that the removal was due to the patient experiencing pain and tenderness under her arm. The explanted generator was later received by the manufacturer. 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, and analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8007544


Title: Re: Arms
Post by: dennis100 on November 24, 2018, 04:44:10 AM
Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected and is suspected to have contributed to the patient's increased.

Event Description
The vns treating physician reported that high lead impedance was found during an office visit on (b)(6) 2013. The patient was last seen on (b)(6) 2012 at which time the lead impedance was within normal limits. The physician reported that an x-rays confirmed a distal fracture. The patient was for replacement surgery as soon as possible to prevent more seizures. Clinic notes from the patient's visit on (b)(6) 2013 were received which indicated the patient continued to do well. However, the patient had a breakthrough seizure earlier in (b)(6), followed by brief myoclonic jerks involving his upper limbs. Since then, he has not had any further seizures. He is seizure free on the ketogenic diet. Also on the last office visit, his seizure medications were being weaned off and had been over of seizure medications for about 8 months. The patient had breakthrough seizures that seem to be related to vns lead fracture. Given the good seizure control, the plan was to continue to wean the patient off of seizure medications. Attempts for additional information from the physician's office have been unsuccessful to date, including to obtain a copy of the x-rays. Although generator and lead replacement surgery is likely, it has not occurred to date.

Manufacturer Narrative
Device failure occurred, and it was believed to have contributed to the patient's increased seizures.

Event Description
Additional information was received from the hospital reporting that the patient had generator and lead replacement surgery on (b)(6) 2013 and the explanted products were available for return. The explanted products were received by the manufacturer on (b)(6) 2013 for analysis. The return product form indicated the reason for replacement as prophylactic generator replacement and due to lead discontinuity. The implant card was also received and confirmed the date of surgery and indicated the reason for generator replacement as battery depletion with near end of service marked. Product analysis has not been completed to date.

Event Description
Operative notes from the patient's revision surgery on (b)(6) 2013 were received which indicated the diagnosis as placement of new lead due to fracture and generator secondary to end-of-life due to length of implant. The patient was doing well but began to lose efficacy with vns. Imaging was obtained which showed a fracture of the lead, explaining the device's 'failure to work. ' during the procedure, an incision was made over the old scar in the neck and dissection was carried down to remove the lead and the anchors. There was significant scar tissue surrounding the sternocleidomastoid, which was carefully dissected free by the surgeon. The lead dove directly posterior at this point, and the surgeon worked through the scar tissue to identify the connecting portion of the electrode. However, the nerve was scarred-in quite heavily, and the surgeon was unable to locate and free up all three of the components that held the nerve. The nerve was traced superiorly into the cicatrix and he tried to free up enough to again identify the previous electrodes, but the scar tissue was so heavy so the surgeon did not feel that he could 'safely dissect the nerve free without some type of injury to it. ' at this point, the surgeon felt that 'removal of the old electrode component was probably not worth the risk of injury to the nerve, and again try to free up as much nerve as possible, although the amount of exposure was very limited. ' the new set of electrodes were then successfully wrapped around the nerve. The surgeon felt that he had adequate contact of the two superior components of the lead, and the third electrode was able to be adequately wrapped around the nerve by laying it down inferiorly. Upon disconnecting the previous lead from the generator, a fracture was observed in the lead. The replacement lead was connected to the replacement generator which resulted in normal impedance upon diagnostics. He noted in the notes that the two electrodes appeared to have good relationships with the nerve. Attempts for additional information from the surgeon have been unsuccessful to date.

Event Description
The surgeon's office reported that there was noted to be scarring around the electrode and vagus nerve. However, the believed cause/relationship to vns was not provided. It may be reasonably assumed that it was related to presence of the electrode on the nerve.

Event Description
Product analysis of the generator showed no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was also completed. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis an abraded opening was observed on the outer silicone tubing and both of the inner silicones were found to be abraded open in half; therefore determination could not be made between the (-) connector pin and (+) connector ring quadfilar coils past this point. These coils were identified as quadfilar coil 1 and quadfilar coil 2. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 239mm, 242mm and 245mm from the end of the connector boot. The (+) connector ring quadfilar coil appeared to be broken approximately 240mm from the end of the connector boot. Scanning electron microscopy was performed and identified the coil break areas as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis quadfilar coil 1 appeared to be broken approximately 247mm from the end of the connector boot and quadfilar coil 2 appeared to be broken approximately 253mm from the end of the connector boot. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting on the quadfilar coil 1 coil break. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Review of the lead manufacturer history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950000


Title: Re: Arms
Post by: dennis100 on December 07, 2018, 09:25:45 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/25/2018
Event Type  Injury   
Event Description
It was reported that after a patient underwent vns revision surgery, the patient suffered a stroke due to the patient's jugular vein being nicked at the time of surgery. The patient is also experiencing arm weakness which the neurologist attributes to have been caused by the stroke. The patient was reported as undergoing occupational and physical therapy for the arm weakness. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8072513


Title: Re: Arms
Post by: dennis100 on December 07, 2018, 09:26:27 AM
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing increase in seizures and pain on the life side of their body and also felt pain starting in their fingers and working its way up their left arm, back, and their leg. The physician ran diagnostics on the patient's device, and the reported diagnostics were within normal limits. The physician evaluated the patient for pain and stated that she does not believe the pain was related to vns since the pain does not coincide with vns stimulation or the placement of the vns device. The physician also explained to the patient that they magnet may not be able to able stop all seizures immediately, however it could help shorten the seizure. It was also stated that the physician does not believe that the patient has reached proper dosing levels. The physician decided to disable the patient's device in order to evaluate the complaints of pain and seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8103990


Title: Re: Arms
Post by: dennis100 on December 07, 2018, 09:27:12 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported that the patient began experiencing painful stimulation and pain, in their neck and left arm, associated with vns after implantation of a back stimulator. The pain was said to occur every 3 minutes, and resulted in the patient's device being turned off. Device diagnostics were performed prior to the device being turned off, and were found to be within normal limits. After the device was turned off, the patient reported that they were still experiencing both neck and left arm pain due to the vns and felt as if the device was still providing stimulation and the physician stated that although the device was turned off, a device malfunction could not be ruled out. The patient wanted the vns removed, so the patient underwent device replacement surgery. The newly implanted device was turned on and previous symptoms that the patient had reported were not seen. Additional information was received from the physician that the patient started experiencing the pain sometime after her tens unit was placed in her back. The physician also stated that they are not sure what caused the pain however the patient thought it may have been related to the tens unit. The physician went on to state that the patient's surgery referral for the patient's comfort and to ensure that the patient continued to have benefit from the vns. The physician stated that they were not positive of what could be cause the painful stimulation and stated it could be possibly due to the tens unit, abnormality of vns, or related to patient anxiety, and the physician could not sure what could have caused the pain while the device was on. No other relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8071032


Title: Re: Arms
Post by: dennis100 on December 08, 2018, 01:55:18 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Injury   
Event Description
The patient's mother reported that the patient had been in the hospital due to vomiting, gagging, pain under each arm, hiccups and hypotension. The patient's vns was disabled for 24 hours in the hospital. When the device was off, there was no gagging and vomiting. When it was turned back on, the gagging and vomiting was less. The patient had reportedly lost 5 pounds since the vomiting started. After a full gi work-up, nothing but gastric irritation was found. The treating physicians in the hospital didn't think that the vns was the cause, but they wanted to further investigate and confirm this. The patient's mother reported that the treating physician said that her daughter was using the magnet too often. The patient was in the hospital for approximately 2 weeks. The patient's mother also reported that the patient was now experiencing pain at the generator site. When the patient saw another doctor for follow-up, he did believe that the patient's vomiting, nausea, pain at chest, under arms, hypotension and hiccups were related to the vns stimulation. He indicated that the patient's output current was too high at 2. 75 ma, so he decreased it to 2. 5 ma due to the vomiting and hiccups. No device error was noted by the physician. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8036490


Title: Re: Arms
Post by: dennis100 on December 09, 2018, 03:26:36 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/22/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Per clinic notes received for the patient's replacement, the generator is loose in the patient's anterior chest and migrated towards the left axilla causing pain in the left arm. It was also reported that the vns is causing shortness of breath at times. Therefore the patient was referred for surgery. Per the sales representative, the physician is new to vns and does not have opinions on the migration. No surgery has occurred to date. No additional relevant information has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8075978


Title: Re: Arms
Post by: dennis100 on December 14, 2018, 06:45:41 AM
Model Number 105
Event Date 07/19/2013
Event Type  Injury   
Event Description
Additional follow up with the neurologist's office confirmed that the patient has still not reported the events to the office.

Event Description
The patient reported via (b)(6) that she had surgery seven days prior to replace her vns generator was still hurting. The patient later contacted the manufacturer and reported that the top of her incision appeared to be slightly opened. The surgeon was contacted; however, he stated that they had not seen the patient since surgery. On (b)(6) 2013, the patient reported that she was okay and was not complaining about pain or the device. She stated that she was in pain on the day of surgery for a while when the device was programmed, but now that she has healed more the stimulation is not as painful. The patient stated that the incision scar is still pretty painful when she does a lot of stretching of her arm, but that she knew this was part of the healing process from having surgery. Otherwise, the patient said she was fine and did not need to see her physician and only went on an emergency basis. The patient again clarified that she felt she was okay in the healing process and was not having issues with the device itself. Follow up with the physician's office indicated that the patient has not been seen since her pre-op visit. Follow up with the patient's other physician indicated that she was seen on the morning post-op the day after replacement surgery and has not been heard from since. It was stated that the patient has not reported any problems or complaints, so they were unaware of any issues. The patient's device was programmed on to previous settings at the post-op visit. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3330872


Title: Re: Arms
Post by: dennis100 on January 04, 2019, 09:26:44 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a newly implanted patient that she was experiencing pain in her chest that would feel like it was radiating from her clavicle to her sternum, through her left breast, armpit and down her left arm, leaving her middle 3 fingers "tingly". The patient was told during her follow up appointment that she was experiencing "frozen shoulder" and was given exercises to resolve the issue. Upon follow up with another physician, it was noted that her anatomy may have caused a nerve to be compressed. The patient stated that her generator was placed in the crease of her armpit. A ct scan was performed to "check the nerves", and the physician also noted possibly performing a "tunneled revision" in order to reposition the device. In a separate call, it was reported by the patient that she eventually lost mobility in her left arm and also suspected that the device had migrated. It was stated that results of the scan were still pending, and it was clarified that the pain was constant and persisted even when inhibiting stimulation with the magnet. The patient further reported a rash on her chest around the generator site that was being treated with an antibiotic. The patient stated that she was meeting with the surgeon to discuss emg results on her left arm: if the results were fine, the surgeon suggested device explant. The surgeon had also stated he could implant the device on the right side, but did not want the same thing to be occurring for both sides. The patient expressed frustration as she felt the physician was "blaming" her anatomy and did not want the device removed as she fought to have the device implanted for a better quality of life. A further update noted that the patient was to have a repositioning surgery before the end of the year to move the device just below her clavicle. Follow up with the physician seeing the patient confirmed that there was no migration and that a surgery (repositioning surgery) would be occurring for patient comfort, and not to preclude a serious injury. The surgeon did not known the cause of the patient's pain, immobility, and tingling sensation and noted that it could be related to a "cutaneous nerve irritation". The cause of the rash was also unknown. The rash was confirmed to have been resolved, and intervention taken was indicated to be for patient comfort and not to preclude a serious injury per the physician's response. No 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=8190458


Title: Re: Arms
Post by: dennis100 on January 04, 2019, 09:27:18 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2018
Event Type  Injury   
Event Description
It was initially reported that the patient complained of pain throughout her arm and numbness from her should to finger tips. It was stated that this occurred all of the time. The physician's office stated the diagnostics were within normal limits. The patient was informed to follow up with a surgeon, but the surgeon's office did not take the patient's insurance. The patient later reported that she had been experiencing problems with her arm and could not move it. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8189859


Title: Re: Arms
Post by: dennis100 on January 05, 2019, 02:57:40 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced painful stimulation at the electrode site in the neck in the middle of the night for 10-15 minutes. Additionally, clinic notes from the next day indicated that the patient had experienced a very severe cough, voice alteration, sharp pain sensations in left arm/shoulder and chest, as well as shortness of breath. The patient's device was disabled due to these adverse events. The patient reported that the device stimulated despite the disablement and that the voice alteration and pain persisted with the device being programmed off. The patient had not experienced any known trauma. The physician reported that the patient's adverse events were likely due to a lead malfunction, however, device diagnostics for the patient were within normal limits. The physician indicated the patient would be referred for a generator and lead replacement for patient comfort and to preclude a serious injury, and that the patient's battery was low. 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=8127177


Title: Re: Arms
Post by: dennis100 on January 11, 2019, 02:46:34 AM
Type of Device:           Cyberonics VNS Pulse Generator
Device Brand Name:    Demipulse
Device Manufacturer's  Cyberonics
Name:
Date of this Report:     03/08/2011
(mm/dd/yyyy)
Describe the Event      Explantation of Cyberonics VNS Demipulse model 103 from left upper
or Problem:                anterior chest due to malfunction. Patient reported shock-like
                                 sensation on the site extending up to the neck and down to left arm and
                                 left upper abdomen. Patient did not experience permanent harm.
the device(s) may
have                          Minor injury to the patient or health care provider
caused or contributed
to:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=23991


Title: Re: Arms
Post by: dennis100 on January 15, 2019, 02:58:05 AM
Model Number 302-20
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that clinic notes on (b)(6) 2013 note that device diagnostics were within normal limits. The patient's wife indicated that vns therapy did not help the patient and that the patient's arm was sore near the implant site. The patient requested to have the vns explanted.
 
Manufacturer Narrative

Event Description
It was reported that the explanted devices are not available for return to the manufacturer for analysis.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2013 to explant his generator and lead due to a painful lead pulling sensation on the left side of his neck. The patient¿s device had previously been disabled in (b)(6) 2013 due to lack of efficacy. The painful lead pulling sensation continued with the device disabled. The generator and lead were explanted because the presence of the device was causing the pain and the patient never received efficacy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813078


Title: Re: Arms
Post by: dennis100 on February 09, 2019, 01:58:37 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/31/2018
Event Type  Injury   
Event Description
The patient reported that they are having inflammation and are unable to turn their neck. The patient¿s neurologist was looking for a surgeon in order to have their device explanted. Clinic notes were received for the patient¿s explant surgery. Per the clinic notes, the patient has neck pain that she believes is due to the lead pulling on their nerve. The pain occurs intermittently and mild head turns can set off severe pain in her neck and in the muscles, and she limits her neck motion and arm motion to avoid pain. The patient¿s device was disabled for about two years. Programming history was reviewed for the generator. The generator normal mode was disabled on (b)(6) 2013, however magnet mode was left on. The patient¿s generator was completely disabled on (b)(6) 2015. No programming anomalies were seen. Information was received from the physician's assistant. It was unknown when the patient¿s pain began, and the patient had x-rays taken that appeared normal. The physician¿s assessment on the pain was unknown. The patient¿s device was disabled prior to her coming to their clinic, and the reason for disablement was unknown. 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=8272345


Title: Re: Arms
Post by: dennis100 on February 17, 2019, 06:19:58 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489520


Title: Re: Arms
Post by: dennis100 on March 08, 2019, 01:46:58 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient experienced increased seizures, body twitching, numbness in the right arm, and occasional left leg weakness. The physician attributed these events to the vns generator being at a low battery status. The physician clarified that the patient's current increased seizure levels are at/below pre-vns levels. The patient has been referred for vns replacement surgery due to these events. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8380159


Title: Re: Arms
Post by: dennis100 on March 21, 2019, 01:23:54 AM
Model Number 302-20
Event Date 10/06/2015
Event Type  Malfunction   
Event Description
It was reported that vns system implanted in the patient was tested and system diagnostics returned high impedance with dcdc code 7 and neos no. X-rays were taken and sent to the manufacturer for review. The generator appears to be placed under the right arm in an abnormal arrangement. The filter feed-through wires appears to be intact. The insertion of the lead-pin connector could not be fully assessed due to the orientation of the generator in the x-rays and the quality of images, it appears to be not fully inserted. The electrodes appeared to be placed in abnormal arrangement, not in the neck. A strain-relief bend and a loop were not used. Only one tie-down was found holding the upper lead body. Part of the lead appeared to be 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. It was reported by the physician that the device was not switched off yet. No known surgical interventions have occurred to date. No patient adverse events were reported to date.
 
Event Description
Further information was received from the facility, indicating that the patient underwent full replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity and the generator was prophylactically replaced. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. It was reported that the explanted devices will not be returned to the manufacturer as they were discarded. Therefore, no analysis results could be provided. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5194237


Title: Re: Arms
Post by: dennis100 on March 21, 2019, 01:24:39 AM
Model Number 103
Event Date 09/25/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was complaining of swelling and tenderness around the generator site. The swelling and pain was believed to be due to some scar tissue that had developed since implant that caused severe pain and irritation when the patient moved her arm. The patient underwent a generator pocket revision surgery on (b)(6) 2015 and a hematoma was identified at the generator site. It was reported that this was caused by the patient doing some lifting too soon after vns implant surgery. No migration had occurred. The hematoma was drained and the generator was re-sutured in place. Diagnostics following the revision were within normal limits. No additional relevant information has been received to date.
 
Event Description
The patient was seen in follow-up with the surgeon and it was noted that there was still swelling in the neck area. The surgeon ordered a laser treatment, but is certain he will need to proceed with another surgery. No additional surgical interventions have been performed to date.
 
Event Description
It was reported that the patient was seen by an ent who performed a laser procedure. It was found that there is a gland that is leaking and a procedure will need to be performed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5197508


Title: Re: Arms
Post by: dennis100 on March 23, 2019, 01:43:12 AM
Model Number 104
Event Date 12/01/2015
Event Type  Injury   
Event Description
On (b)(6) 2015 it was reported by the patient's mother that the patient has had recent unusual seizure activity that started over the last few months (that she thinks are simple partial seizures) and thinks are possibly related to the device function. She wants the patient to see the physician to check the vns device. The patient's mother went to the physician's office and reported that she wants the vns "worked on". Per the nurse, the mother did not report any change in the patient's seizures. The patient's mother later reported that the patient was having an increase in partial seizures and that the vns generator was not delivering the appropriate amount of therapy. She stated that she thinks the physician "switched the battery to save settings. " the mother feels that the increase in seizures is above pre-vns baseline levels. The patient's mother stated that there is a change in behavior; the mother described this as stiffening of arms and right side of body, quick arm and hand movements, incontinence, and unusual desire for excessive water. She said these were all things that were well controlled and are now occurring more frequently. The mother indicated that there has been no change in medication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5304878


Title: Re: Arms
Post by: dennis100 on April 06, 2019, 01:43:56 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293


Title: Re: Arms
Post by: dennis100 on April 16, 2019, 01:08:37 AM
Model Number 304-20
Event Date 08/23/2016
Event Type  Malfunction   
Event Description
It was reported by the physician's office that high impedance was observed with the patient's vns device. It was noted that due to the high impedance, the output current delivered to the patient was less than the intended programmed settings. It was later noted by the physician's office that x-rays were taken an came back negative. The patient was referred for surgery; however, no known surgeries have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had both his lead and generator replaced on (b)(6) 2016 due to high impedance. After the patient was replaced, his vns was checked and it was confirmed that his device was working as intended with an impedance value of 1939. It was later confirmed by the physician that the patient's pain over the generator site was due to the high impedance observed prior to the vns revision. The device is not expected to be returned as the explanting facility will not return to the manufacturer.
 
Manufacturer Narrative
This information was inadvertently left off of the initial mfr. Report.
 
Event Description
Clinic notes were received and it was noted the patient had voice alteration with stimulation; therefore, the settings were adjusted to try to resolve the voice alteration. The voice alteration appeared to begin at the same time as the high impedance occurred. Additionally, it was noted the patient was having a sharp pain over his generator periodically and sometimes with movement of his arm.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965755


Title: Re: Arms
Post by: dennis100 on April 16, 2019, 01:09:21 AM
Model Number 302-20
Event Date 09/01/2015
Event Type  Injury   
Event Description
It was reported that a patient had full revision surgery due to an unknown reason. Further information was received indicating that the full revision was done because the patient experienced pain in the left upper extremity, which, according to the surgeon, was due to the placement of the original lead. The cause of the pain was due to lead migration. However, the cause of the migration was unknown. The physician reported that the surgery was done for patient comfort and to preclude a serious injury. The explanted generator and lead were received on 08/10/2016. Analysis of the lead identified no anomalies. Analysis of the generator also identified no anomalies. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5962153


Title: Re: Arms
Post by: dennis100 on April 24, 2019, 02:33:44 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/02/2017
Event Type  Injury   
Event Description
It was reported by a physician on (b)(6) 2017 that a patient¿s device was ¿poking out¿ and the patient presented to the er the week before. He reviewed the patient's device via ultrasound and discovered that the generator had been flipping and had migrated. The surgeon stated that he always sutures the generator in place but that he would have to perform a revision to re-suture the generator in place. The patient then stated she had a lot of chest pain and was going for revision of her pocket because her surgeon told her that it was moving too much. Surgery to secure the generator occurred. The patient later provided on (b)(6) 2017 that the generator was flipping over from 4 months prior, and was moving to her arm. The patient reported this caused tremendous pain, but it was flipped surgically, and re-stitched. Additional relevant information has not been received to-date.
 
Event Description
The patient then later provided that before the repositioning surgery it felt like she was being strangled over 2-3 minutes apart and she was in excruciating pain. The patient repeated that she was in pain from the generator migration and that when trying to use her arm the generator would turn over 180 degrees.
 
Event Description
Follow-up from the patient was received providing that he says she had her device adjusted about a year ago and stated the physician had to turn it down because it was too high, and increased her seizure medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6960601


Title: Re: Arms
Post by: dennis100 on June 02, 2019, 07:27:33 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2017
Event Type  Injury   
Event Description
A patient was admitted to the hospital after experiencing sinus bradycardia, tachycardia, and syncope. The patient's family doctor, who did not manage the patient's vns, did not believe that the arrhythmias and syncope were related to vns; however, the medical staff at the admitting hospital wanted to monitor the patient to understand whether there was a relationship between the arrhythmias and syncope to vns. Both the medical staff and family doctor believed that the syncope was potentially related to the bradycardia as it occurred when the position rose to a standing position after sitting down. Monitoring determined that the patient's bradycardia was constant during both vns stimulation on and off times. According to the nurse at the admitting hospital, the patient had previously been admitted to another hospital for nonsustained ventricular tachycardia three years prior to the recent arrhythmias. The patient's resting heart rate was reportedly 54 beats per minute. Device diagnostics were performed and returned results within the normal limits. Additionally, the patient reported that her vns settings had not been changed by her prescribing psychiatrist in over 5 years. The attending nurse later reported that she believed that the patient's blood pressure medication was adjusted during the hospital, but she did not know of the cause of the arrhythmias and syncope or their relation to vns. No further relevant information has been provided to date.
 
Event Description
Clinic notes were received from the patient's er visit that indicated that the patient was admitted to the hospital after experiencing cardiac-related chest pain that was unrelieved by nitroglycerin. The patient's resting heart rate on intake was 51 beats per minute, and her blood pressure was 104/70, which was indicated as within the normal limits. The chest pain radiated to the patient's left arm and shoulder. The patient was noted to be bradycardic. X-rays taken on the day of admission showed cardiomegaly, but there was no evidence of that condition observed in x-rays the following day. Per the clinic notes, the vns was interrogated and observed to be at neos = no with diagnostic results within the normal limits. The vns was disabled via magnet inhibition while the medical staff attempted to discern the relation of the vns to the patient's bradycardia. The medical staff later assessed that the chest and left arm pain were caused by the patient's beta blockers. The patient's medications were adjusted several times during the hospital stay. The chest pain appeared to resolve after a change to new medication, and the patient was discharged from the hospital in stable condition. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685193


Title: Re: Arms
Post by: dennis100 on June 04, 2019, 08:10:44 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2006
Event Type  Injury   
Event Description
It was reported by the caregiver that the patient's implant site was so swelled up after the generator replacement surgery that the patient was hospitalized overnight, even though it was originally supposed to be an outpatient procedure. The caregiver reported that a week later it was still swollen and they stuck it with a needle, expecting fluid to drain out, but nothing came out. The caregiver stated that the surgeon had "no idea what the swelling was about and to this day doesn't know".
 
Manufacturer Narrative
Report source, corrected data: initial report inadvertently selected other and input 'caregiver' instead of selecting consumer.
 
Event Description
It was reported via clinic notes that after a period of time following the surgery, fluid was extracted from around the wound site and was sent to the lab for evaluation of the cultures. It was noted that the swilling was nonpurulent and there was no drainage nor had the patient been having any fever. Clinic notes from a later date indicated that both incisions were in very good condition and there was no fluctuance, redness, or apparent tenderness. The surgical notes indicated that the incision sites were irrigated with bacitracin solution.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #01 inadvertently left out the information regarding the reported hematoma. (b)(4).
 
Event Description
The clinic notes received also contained notes from a second physician that indicated that the patient had a hematoma that was beneath the patient's skin, not the pectoral muscle, that was still quite apparent. It was noted that the yellowish discoloration had spread over the chest, down to the left elbow and over the clavicle. It was noted that the hematoma area was fluctuant, but did not feel hot and was not tender. The physician attempted to aspirate the area was only able to aspirate only 2 to 3 cc of blood, which was sent for culture. It is unclear if the reference of swelling from one physician was the same as hematoma referenced by the second physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6808989


Title: Re: Arms
Post by: dennis100 on June 09, 2019, 01:40:37 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/26/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing numbness and pain under his arm following vns implant surgery. The patient was initially prescribed pain medication however this did not provide the patient any relief from the pain. It was later reported that the patient's neck and chest incisions from the surgery were not healing well. The patient was then taken to surgery for wound debridement and incision revision. Manufacturing records for the lead and generator were reviewed and confirmed that both devices were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
It was later reported that when the patient was having the wound healing issues the incision had opened and was infected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6853405


Title: Re: Arms
Post by: dennis100 on June 21, 2019, 12:46:42 AM
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
 
Event Description
A patient reported that after implantation with vns, her left vocal cord had not been the same. It is unclear if the patient sustained a vocal cord injury during implantation with vns or after her device was explanted. The patient also reported that she had also experienced difficulty swallowing since explant. No additional relevant information has been received to date.
 
Event Description
The explanting physician's office reported that the patient's generator and a portion of the lead were explanted due to persistent left arm pain, both with and without stimulation. The explant surgery was not required to preclude a serious injury. It is unknown if the dysphagia and vocal cord injury that the patient reported were a result of this explant procedure. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7194052


Title: Re: Arms
Post by: dennis100 on June 27, 2019, 12:18:35 PM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for patient's generator replacement referral. Per notes , the physician noted tenderness on the chest wall when the vns was interrogated. Case manager contacted the neurologist office for the reason for the referral and mentioned that the surgery may just be repositioning surgery for the pain in the chest. At the surgeon's consult appointment, the surgeon mentioned that the patient was ok. The surgeon has deferred repositioning the device. No known surgical interventions have occurred to date.
 
Event Description
Patient was seen by the surgeon for evaluation of neck symptoms as there was a question as to whether these might be related to an existing vagal nerve stimulation. Patient reported intermittent arm numbness, episodes of shaking and pain that seems to radiate from the shoulder and left arm downward she also intermittently describes left arm weakness. The physician indicated that these events sound a lot more like radiculopathy-cervical disc disease than it does anything to with vns device. The surgeon was pessimistic that removal of the device would change symptoms at all and recommended the patient to see someone who specialized in spine disc disorders. The physician reported that the surgery was not planned for the pain. The pain began in (b)(6) 2018 and the cause is suspected to be musculoskeletal reason. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7318737


Title: Re: Arms
Post by: dennis100 on July 04, 2019, 01:15:18 AM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient underwent repositioning surgery for a generator that ¿came loose¿. Follow-up from the provider clarified that the generator repositioning surgery was due to the generator ¿moving around¿ only during certain arm movements and the generator would pop out of the pectoralis muscle pocket. The physician stated she had a lot of soft tissue and it looked the initial pocket was maybe a little superficial to remain stable. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Device evaluated by mfr, corrected data: the device evaluation field was inadvertently marked incorrectly on the initial report. Additional manufacturer narrative and/or corrected data , corrected data: information regarding the use of code in device evaluated by mfr? was inadvertently not provided on the initial report. Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7706870


Title: Re: Arms
Post by: dennis100 on July 11, 2019, 01:37:23 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient was experiencing pain and was not tolerating magnet swipes. Clinic notes were provided and mentioned that the patient gets a left-sided pulling of her mouth and body twitching with every magnet swipe, along with headaches. This is said to have been going on for a few months. Clinic notes also mentioned that patient experienced an event where she was shaking, and her left lip was "drawn downward;" she was having difficulty using her left side upper extremities and her arm was painful. This was reported to have occurred after the magnet was used during diagnostics. The physician disabled the vns due to patient¿s episodes after magnet swipes. The patient stated that although the device was turned off, the "pulling" sensation on the left side of her face persisted, and she had tightness on the left side of her upper extremities. The patient was reportedly taken by ambulance to the hospital and admitted for one night. It was also mentioned in the notes that the patient is too afraid to use the magnet to abort seizures because of the mouth "pulling" sensation. The physician informed that the a surgery referral has been placed for patient comfort reasons. Additionally, the physician believes that the reported side effects may be related to the patient's pseudo seizures. The reason for the patient¿s hospitalization was not provided. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8676229


Title: Re: Arms
Post by: dennis100 on July 14, 2019, 04:33:26 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received from a visit dated (b)(6) 2018 providing the patient will have a pocket revision due to pain as an x-ray showed the generator has migrated. The patient explains the pain began in (b)(6). It was also noted the patient feels shortness of breath and numbness into her left shoulder and arm. Impedance on (b)(6) 2018 showed impedance within normal limits. Follow-up from the provider indicated the patient states the vns had moved after being placed. Generator replacement surgery. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7747257


Title: Re: Arms
Post by: dennis100 on July 16, 2019, 11:21:31 PM
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2015
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events were not related to the functionality of the device.
 
Event Description
It was reported that a patient has been experiencing nausea and pain since having the m105 generator implanted. She stated that the generator was too large for her small frame, as she weighs 105 pounds, and the generator is visible through her clothes. The patient also stated that the generator moves when she moves her arm. She was looking to receive a smaller generator as the m103 generator gave her no issues. Follow up with the surgeon's office confirmed that non-resorbable suture was used to secure the generator. It was further stated that a m103 device was placed in aug 2015 and that the surgeon's office had not heard from the patient in regards to nausea, pain, protrusion or migration. Attempts were made for follow-up with the psychiatrist's office. It was stated that the patient had spoken to the physician regarding a larger implant, but no other information was available. It could not be clarified if a model 103 device or model 105 device was implanted. It was stated that the patient was scheduled for explant surgery due to the reported events. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7921428