Pages: [1] 2 3 ... 11   Go Down
Print
Author Topic: Arms  (Read 64967 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« 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
« Last Edit: November 29, 2016, 03:46:20 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #1 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
« Last Edit: December 21, 2015, 11:22:55 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #2 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #3 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
« Last Edit: December 08, 2015, 10:56:34 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #4 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #5 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #6 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #7 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #8 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #9 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #10 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #11 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #12 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #13 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #14 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #15 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #16 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #17 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #18 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #19 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #20 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #21 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
« Last Edit: April 23, 2018, 09:26:00 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #22 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #23 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #24 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #25 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #26 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #27 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #28 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #29 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
Logged
Pages: [1] 2 3 ... 11   Go Up
Print
Jump to: