Pages: 1 [2]  All   Go Down
Print
Author Topic: Abdomen  (Read 11489 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #30 on: October 06, 2017, 10:10:17 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 08/16/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient woke up one day and was experiencing severe pain in the chest and neck. There was no known trauma to the vns and the neurologist didn't know what the cause was. The patient's settings were lowered and x-rays were ordered. Clinic notes indicated the patient patient's mother had called and reported that the patient was having severe chest pain and the patient was given fentanyl en route. A chest x-ray was unremarkable. A neurologist disabled her normal mode output current. Post pain medications and device disablement , the pain went away with no recurrence. The pain appeared to be prominently in the left side of the chest but also went into her neck and lower trunk region. The patient's mother indicated that the patient's pain was cyclical. There was no recent trauma to the head, neck and chest, and no patient manipulation. When the vns was turned on to 0. 5 ma the patient began to experience pain again, and her device was re-disabled. It was believed that the patient's pain was related to stimulation. The patient's device was reportedly working properly with good impedances. The physician believed that the patient's generator and leads may need to be replaced. The pain was reported to be serious. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6858790

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #31 on: October 19, 2017, 01:25:34 AM »

Model Number 103
Event Date 01/01/2013
Event Type Malfunction
Event Description
It was reported that the patient underwent generator and lead replacement surgery. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the returned lead and generator was completed on (b)(4) 2014. Analysis of the returned generator revealed no anomalies, and the device performed according to specifications. The output signal of the generator was monitored for more than 24-hrs and the 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. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead revealed that, other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

Manufacturer Narrative

Event Description
Follow up with the physician found that the physician tried the magnet on the patient and there were no muscle spasms, and therefore did not believe they were related. On (b)(6) 2013, the patient reported that she had a seizure the night prior and went to the ed. After being released from the ed, they patient was called back and told that the cat scan showed a tumor, cyst, or spot on her brain. Per the patient, the leads were on backwards and she was having a lot of gi problems. Follow up with the physician found that the patient was no longer his patient as of the last six to seven months. However, the patient was under the physician's care as of (b)(6) 2013. The patient's vns was found to be in proper working order and of proper function. Diagnostics on each visit were found to be appropriate as of the last visit on (b)(6) 2013. The patient has had seizures on and off since the initiation of her care in 2011. On her visit of (b)(6) 2013, the patient stated that she had a seizure the day previous on (b)(6) 2013. Over the last several months, the patient's vns has been adjusted. Her output has been increased. Her medications have also been adjusted appropriately. The physician received a fax from the patient on (b)(6) 2013 stating, "the last medication and vns adjustments that you made worked perfectly and i haven't had a seizure since my last appointment. " her last appointment before (b)(6) 2013 was on (b)(6) 2013. The patient alleges that has had increased seizures for six to seven moths; however, her seizures have been somewhat sporadic. The patient's chart also alludes that she has had a complaint of abdominal spasms, possibly not related to her seizures. The physician's inquiry did not reveal any relationship of these spasms to her vns device whatsoever, however, he stated that he is now aware that they patient told the manufacturer that her spasms are related to her magnet use. When the magnet diagnostics were performed in the physician's office on the patient's last visit of (b)(6) 2013, the patient had no evidence for abdominal spasm visually perceived by the physician nor complaint of the spasm at that time, verbally complained by the patient. No cause or contributory programming changes, medication changes, or factors that the physician is aware of seem to increase the patient¿s seizures. In summary, the patient¿s vns device appears to be working properly. There appears to be no connection between the patient¿s vns device and her complaint of increased seizure events. No additional information has been provided.

Event Description
On (b)(6) 2013, the patient reported that she has been having some "bizarre" symptoms lately and that she has been having an increase in seizures over the past six to seven months. She stated that she has about one per day. The patient is also experiencing muscle spasms in her abdomen on the left side that is affecting her bowel movements. On (b)(6) 2013, the patient reported that she is having issues with her magnet not helping her stop her seizures and that she is experiencing muscle spasms in her diaphragm and abdomen. The patient is not sure if the muscle spasms are related to her vns, but has noticed the spasms occur when she uses her magnet. Follow up with the physician found that the patient was seen in her office on (b)(6) 2013. The physician ran diagnostics and everything was ok. The physician stated that she swiped the patient's magnet and the patient was able to feel stimulation. There were no muscle spasms or any issues with the patient when she received the magnet stimulation. Per the physician, the patient appeared anxious, so it was discussed if she should see someone for her anxiety. No additional information has been provided.

Event Description
Clinic notes dated (b)(6) 2013 note that the patient suffered a seizure while driving in (b)(6) 2013 and rear-ended another vehicle at 70 ml/h. It was noted that since then the patient's seizures have significantly worsened. It was noted that the patient's output current was reduced and she was doing somewhat better. It was noted that device diagnostics showed lead impedance "ok". The patient was sent for x-rays of the chest and abdomen. Chest x-ray report indicated that the x-ray did not identify any obvious lead fractures. Abdomen x-ray report indicated that the impression was a negative exam.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3283359
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #32 on: October 24, 2017, 01:06:11 AM »

Model Number 104
Event Date 04/01/2013
Event Type Injury
Event Description
On (b)(6) 2013, a patient¿s mother reported that her son developed gastroparesis in (b)(6) 2013. The mother stated that the physician had said they have no information on what it could have been caused by. The patient¿s device was last interrogated on (b)(6) 2013, and to the mother¿s knowledge, everything was ok. There were no noted events that preceded the gastroparesis. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Clinic notes were received for the vns patient¿s office visit with his neurologist on (b)(6) 2014. The notes listed epigastric abdominal pain as one of the patient¿s current problems.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3452684
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #33 on: November 07, 2017, 02:00:36 AM »

Model Number 103
Event Date 08/12/2014
Event Type Injury
Event Description
It was reported that the study patient experienced an increase in seizures, epigastric pain with hospitalization, loss of appetite, vomiting, diarrhea and nausea. An adverse event form was received indicating that the patient experienced vomiting, diarrhea and gastroenteritis. It was reported these events were not related to vns and have been resolved. No additional relevant information has been received to date.

Manufacturer Narrative
Report source; corrected data: the previously submitted mdr inadvertently did not indicate "study" as a report source.

Manufacturer Narrative

Event Description
Further information was received which disregarded vomiting and diarrhea as individual adverse events. The reported gastroenteritis was not associated with congenital anomalies or birth defect, it did not result in a persistent or significant disability or incapacity and it was not associated with other serious or important medical events. The reported gastroenteritis was not a life threatening event and it did not result in death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4278678
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #34 on: November 10, 2017, 02:14:59 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/05/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 that the patient experienced dizziness just before the device turns on and if she is standing she feels as if she will pass out. The onset of this event was about 3-4 weeks prior to the report ( (b)(6) 2014). The patient was initially implanted on (b)(6) 2014 and the neurologist last increased her normal mode output to 1. 25 ma. The patient also reported burning in the epigastric region during stimulation. Diagnostics were normal. Additional information received indicated that the patient alleged that her device was stimulating more frequently than every 5 minutes as it was set to do. The patient put a magnet in place to disable the device, and went to urgent care for treatment. Further information was received indicating that the pulse generator had been disabled. X-rays were taking with no remarkable findings by the medical professional. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4468523
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #35 on: November 12, 2017, 03:28:41 AM »

Model Number 105
Event Date 04/17/2013
Event Type Injury
Event Description
It was reported that the vns patient experienced vomiting, melena, abdominal pain, and other various gi issues since (b)(6) 2013. The physician stated that the patient¿s symptoms were more consistent with colitis per colonoscopy. The physician believed that the events were more likely gi related but was unable to rule out vns as a contributing factor. The patient¿s device settings were subsequently decreased. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was received that the vns patient was seen and it was determined that their events were not related to their vns, but rather to colitis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4425509
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #36 on: November 20, 2017, 03:26:54 AM »

Model Number 102
Event Date 04/23/2015
Event Type Injury
Event Description
It was reported that the vns patient had presented increased seizures for 6 weeks. It was reported that the patient had benefited from vns therapy when the duty cycle was increased from 16% to 29%. Night seizures had not occurred since (b)(6) 2015 after the increase in the duty cycle. The night seizures occurred again six weeks earlier and the patient also presented complex partial seizures during the day, after waking up, with anxiety, rapid heartbeat, panting, stiffening of the arms and partial loss of conscience, being able to hear but not to respond. It was also reported that the vns generator was interrogated and the output current was found at 1ma while it had been programmed at 2ma in the last follow up visit, with the rest of the settings unchanged: frequency 25 hz, pulse width 500usec, 21sec on time, 1. 1min off-time, magnet output current 2. 25ma. The patient¿s device was tested and system diagnostics returned impedance results within normal limits with dcdc 2 and normal mode diagnostics returned dcdc 5. It was reported that the impedance results were the same as in (b)(6) 2015. It was reported that the output current was set to 2ma and the duty cycle was increased from 29% to 36% with 21sec on-time and 0. 8min off-time. The patient had not noticed when vns stimulation did not alter the voice any longer. The patient is (b)(6) years old and has had epilepsy since her (b)(6) year. During the first year she had several seizures per year over a period of 3-4 weeks with anxiety seizures and milder seizures with rapid onset of abdominal pain with paleness without loss of consciousness and generalized tonic-clonic seizures. From her (b)(6) year she presented mainly 3 night seizures per week w, no longer in clusters. The epilepsy is mri negative, with both temporal as frontal symptoms. Review of the available programming and diagnostic history showed normal diagnostic results and no programming anomalies through (b)(6) 2015. Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that both the generator and the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4874298
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #37 on: December 10, 2017, 01:52:59 AM »

Model Number 102
Event Date 06/01/2015
Event Type Death
Manufacturer Narrative

Event Description
Clinic notes were received regarding the patient's reason for admission to the hospital and her death. It was noted the patient was admitted to the hospital on (b)(6) 2015 and discharged on (b)(6) 2015. It was noted that the day before she was admitted, she was on the toilet and fell to her side, injured her left ribs, but the staff did not think too much about it because she did not really complain. But, as time went on, she started complaining more of shoulder pain, breast pain, and lateral chest pain, so they brought her into the e. R. Where 2 fractured ribs on the left anterolateral side were found. It was felt by the physician that the patient should be admitted so that they could observe her. The patient was admitted and had no problems over the weekend. On monday morning, the physician was told the patient had an arrest. He discussed with the physician on call and the nurse and it was explained that around 3 am the patient had some nausea and abdominal pain. They provided the patient with zofran and then when they went to check on her again, she had vomited and it was noticed she has some pudding around her mouth. At that time, she was just staring and then just "went out. " a sternal rub was performed and a code was called, but they were unsuccessful. It was decided the patient most likely aspirated and an autopsy was not performed.

Event Description
It was reported by the company representative that the patient had passed away. An obituary search provided the date of the patient's death, but no cause of death was provided. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5463400
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #38 on: December 14, 2017, 03:36:31 AM »

Model Number 103
Event Date 01/29/2016
Event Type Death
Event Description
Follow-up information from the physician indicated that the patient's cause of death was abdominal sepsis / renal insufficiency, not related to vns therapy.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient died on (b)(6) 2016. The patient was implanted with vns on (b)(6) 2014. Attempts for additional information have been made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5499226
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #39 on: April 23, 2018, 01:12:08 AM »

Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Garci´a-navarrete e, et al. Long-term results of vagal nerve stimulation for adults with medication-resistant epilepsy who have been on unchanged antiepileptic medication. Seizure: eur j epilepsy (2012), http://dx. Doi. Org/10. 1016/ j. Seizure. 2012. 09. 008.
 
Event Description
An article entitled ¿long-term results of vagal nerve stimulation for adults with medication-resistance epilepsy who have been on unchanged antiepileptic medication¿ was received. Forty-three patients were followed. After implant, patients were evaluated on a monthly basis increasing stimulation 0. 25 ma at each visit, up to 2. 5 ma. Medication was unchanged for at least 18 months since the stimulation was started. Of the 43 operated patients, 63% had a simulation or great than 50% reduction in seizure frequency. Differences in the responder rate according to stimulation intensity, age at onset of epilepsy, duration of epilepsy before surgery, previously epilepsy surgery, and seizure type, did not reach statistical significations. Most side effects were well tolerated. One patient reported an increase in the duration and intensity of his seizures. Twenty-two patients experienced side-effects. The most common were mild, consisting in hoarseness, neck tingling or occasional coughing at the time when the signal was on, all of which were usually well tolerated. Two patients had intermittent dyspnea, and another patient experienced occasional episodes of dysphagia with stimulation. Irritability was reported by two families, in the context of a general improvement in the level of alertness. Five had severe side effects, requiring their vns generators to be inactivated or explanted. Three of the 5 patients that stopped receiving stimulation had been responders. Reasons for explanation were infection in two patients, and odynophagia, in one patient. One patient had an exacerbation of a previous behavior disturbance, with severe aggressiveness, which improved when the stimulator was inactivated. Seizure reduction was maintained after the stimulation was stopped. Another stimulator was removed at family request, owing to a persistent abdominal pain. One explant due to infection is captured in this report: mfr report# 1644487-2013-01450. The other explant due to infection is captured in mfr report #1644487-2013-01453. The explant due to odynophagia is captured in mfr report #1644487-2013-01449. The explant due to abdominal pain is captured in mfr report #1644487-2013-01447. The report of increased seizure duration and intensity is captured in mfr report #1644487-2013-01444.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3120504

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #40 on: April 28, 2018, 12:53:37 AM »

Model Number 302-30
Event Date 01/16/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2013 that indicated the patient has been experiencing an increase in seizures; the patient had about 30 abdominal rushes (averaging about 6 per month) which is an increase since before (4 per month). The patient also complained of ¿pulling of her vns¿ about once a month, lasting for several minutes, especially when she is laying down at night. The patient¿s settings were noted to be output=3. 25ma/frequency=20hz/pulse width=250usec/on time=60sec/off time=1. 1min/magnet output=3. 50ma/magnet on time=60sec/magnet pulse width=250usec. Diagnostics showed results within normal limits of output=ok/lead impedance=ok/impedance value=1673ohms/neos=no. The clinic notes dated (b)(6) 2013 indicate that the patient has had 20 auras but no seizures since the office visit on (b)(6) 2013. Good faith attempts for further information from the physician were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3170182
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #41 on: May 02, 2018, 01:58:44 AM »

Model Number 302-20
Event Date 03/26/2015
Event Type  Injury   
Event Description
It was reported that the vns patient had presented a sharp pain in the left side of the neck and pulling sensation. The patient did not perceive the stimulation and she could not indicate whether the pain occurred with stimulation or not. The settings were programmed at 1. 5ma, 25hz, 130usec, 30secs on and 5mins off. The patient has dystonia and moves her neck quite a lot. X-rays were recommended but the patient did not wish to undergo any further surgical revision and preferred to have the generator disabled. Additional information was received indicating that the patient was implanted for depression. The pulse generator vns was disabled as the patient was experiencing severe discomfort. The patient wishes to undergo vns explant surgery because she believes that her cervical dystonia/torticollis is being worsened by vns. It was reported that the patient presented a severe pain episode caused by the lead, which seemed to be protruding more than it had done previously. It was reported that the patient also presented breathing difficulties, loss of some vision in one eye, severe pain in the middle of her back and abdominal pain which was relieved by the application of plasters. It was believed that these symptoms were related to the patient¿s depression. Surgical intervention for the explant of the vns system is expected but it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4804054
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #42 on: May 04, 2018, 01:26:11 AM »

Event Date 06/18/2013
Event Type  Malfunction   
Manufacturer Narrative
The initial report inadvertently reported the incorrect date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Review of lead device history records confirmed all quality tests were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
A vns treating nurse reported that the patient who recently had generator replacement on (b)(6) 2013 was recently checked by the nurse for the first time after receiving new medical care. The nurse checked the vns system via diagnostics prior to replacement surgery and in recovery after surgery. All was reportedly okay with the lead, according to the diagnostic readings. The patient was later seen in the local emergency room a couple of days later due to some abdominal pain found to be mostly gas and not related to vns. However, a chest x-ray was performed, and the vns lead was found to be fractured as confirmed by the surgeon. The nurse reported a ¿7. 5 cm gap between the ends of the lead in patient's chest. ¿ the patient was seen on (b)(6) 2013 for post-op vns visit, and she again checked the lead with okay results with lead impedance value at 3561 ohms. The nurse turned off the device on (b)(6) 2013, and reported that the patient may or may not have the lead replaced. No manipulation or trauma was reported to the nurse that may have contributed to the lead fracture. The patient has not reported a change in stimulation perception; however, the patient is developmentally delayed so the nurse is not sure that he would know to report it. Attempts for lead product information have been unsuccessful to date. Ap chest and abdominal x-rays were received by the manufacturer for review. Based on the x-rays images received, there is a gross lead fracture in approximately the middle portion of the lead which is most likely a result of the patient twiddling the lead in the chest. Also, the 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 an additional micro-fracture in the lead also cannot be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3222463
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #43 on: May 15, 2018, 08:22:19 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808957
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #44 on: June 18, 2018, 01:15:16 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808957
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #45 on: June 21, 2018, 12:33:13 AM »

Model Number 302-20
Event Date 06/01/2010
Event Type  Malfunction   
Event Description
It was initially reported that the pt was scheduled for a head scan (with head coil) mri and was in the scanner for 59 seconds. At the time, the pt's mother had not told scanning technicians about the pt's vns device; consequently, it was not disabled during this brief time period. Once the vns implant was discovered, the scan was stopped. The nurse performed a system diagnostics test, which showed high lead impedance. The pt was known to have her pulse generator placed in the abdominal cavity due to her comorbidities. The pt was disabled and the mri was continued. It was later indicated that the pt had a fall about two weeks prior to the mri, of which the mother was not initially forthcoming about. The pt apparently fell and hit her stomach area, which is the place where the pt has her generator placed due to the many shunts she has in place due to her disease. She indicated that she received a copy of the radiologist's reports and there was a note that there was a lead fracture in the neck area. The x-rays were requested to be sent to the manufacturer for review, but have yet to be received. There was a belief that the fall was the cause of the high impedance and not the mri. A search performed in the manufacturer's programming history database showed that the last known diagnostics were within normal limits. It is unk at this time if the pt will be having the device replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774433
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #46 on: July 12, 2018, 01:10:34 AM »

Model Number 103
Event Date 08/12/2014
Event Type  Injury   
Event Description
It was reported that the study patient experienced an increase in seizures, epigastric pain with hospitalization, loss of appetite, vomiting, diarrhea and nausea. An adverse event form was received indicating that the patient experienced vomiting, diarrhea and gastroenteritis. It was reported these events were not related to vns and have been resolved. No additional relevant information has been received to date.
 
Event Description
Further information was received which disregarded vomiting and diarrhea as individual adverse events. The reported gastroenteritis was not associated with congenital anomalies or birth defect, it did not result in a persistent or significant disability or incapacity and it was not associated with other serious or important medical events. The reported gastroenteritis was not a life threatening event and it did not result in death.
 
Manufacturer Narrative
Report source; corrected data: the previously submitted mdr inadvertently did not indicate "study" as a report source.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4278678
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #47 on: October 04, 2018, 04:15:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/30/2014
Event Type  Death   
Event Description
A representative of the following neurologist's facility confirmed that the patient was deceased. The representative did not provide a cause of death for the patient. Clinic notes on file for the patient indicated that the patient was admitted to the hospital for abdominal pain and was pronounced dead two days later. It was unknown whether the patient's abdominal pain was related to the patient's death or to the vns. The representative did not provide an assessment regarding the relationship of the patient's death to vns. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Explanted devices were received from another medical device manufacturer. The reason for explant was not indicated; however, an obituary search indicated that the patient implanted with the devices was deceased on (b)(6) 2014. Product analysis was performed on the explanted lead and generator. Analysis was approved for on the returned generator. An end-of-service message was observed on the generator. Review of the data downloaded from the indicated increased impedance; the pre-change impedance value was 1705 ohms, and the post-change value was 19911 ohms. The time of change detection (b)(6) 2014, indicating likely explant on this date. The pulse generator was tested and performed according to functional specifications, and there were no adverse conditions found with the generator. Analysis was approved for the lead. No discontinuities were identified within the returned lead portion. Setscrew marks were observed on the connector pin, providing evidence that proper contact between the setscrew and the connector pin existed at least once. Microscopy showed that pitting occurred on the surface of the connector ring. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant. Note that since a significant portion of the lead, including the electrode array, was not returned for analysis, an assessment cannot be made on that portion of the lead. No anomalies were identified in the returned lead portion. No additional relevant information has been received to date. The circumstances of the device explant have not been confirmed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7073931
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #48 on: October 29, 2018, 10:33:49 AM »

Model Number 102
Event Date 05/01/2009
Event Type  Injury   
Event Description
It was reported that the patient was having abdominal cramps, vomiting, nausea and multifactorial abdominal pain. The events were severe in nature. Patient was hospitalized. As per medical professional, patient's abdominal pain was possibly related to implantation, vomiting was possibly related to implantation and stimulation, nausea was possibly related to implantation and stimulation and multifactorial abdominal pain was possibly related to stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1431958
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #49 on: January 16, 2019, 02:39:28 AM »

Model Number 302-20
Event Date 04/11/2014
Event Type  Malfunction   
Event Description
The generator appears in the left abdominal area in an abnormal placement.
 
Manufacturer Narrative
The initial manufacturer report incorrectly stated that the x-rays showed normal placement of the generator in the upper left chest. The x-rays showed abnormal placement of the generator in the left abdominal area.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested on (b)(6) 2014 and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently programmed off. There was no change in the patient¿s seizure activity. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin was fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the x-rays images, the cause high lead impedance could not be determined. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. During the procedure, it was noted that the electrode had visible damage right beyond the anchor tether. The explanting facility discarded the explanted products; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3796059
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #50 on: January 20, 2019, 03:26:46 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #51 on: March 14, 2019, 06:09:11 AM »

Model Number 304-20
Event Date 10/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during a vns repositioning surgery for placement of a gastrostomy tube unrelated to vns, the surgeon pulled on the lead and it appeared to have broken while he tugged on it from its location at the upper incision. An implant card was also received indicating the lead was "fissured" during surgery when the lead was pulled back for repositioning. The generator was previously in the abdomen due to the patient's small size. The physician wanted to salvage the lead and replacement was not intended. They needed to re-tunnel for the lead so both incision sites were opened. The physician tugged the lead back, towards the neck. It was reported that the lead had frayed and broken near the lead pin and occurred while the physician was pulling on it very hard by hand. No surgical instruments were used on the lead. Diagnostics after the break were high. It was noted that the case was very difficult based on the patient铠size and complication due to the gastrostomy tube. It was reported that diagnostics were reportedly within normal limits prior to surgery. The generator was replaced as the battery was reported to be at near-end-of-service. The lead was discarded at the end of the procedure. The explanted generator has not been received to-date. No additional information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5190183
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #52 on: April 06, 2019, 01:46:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/26/2019
Event Type  Injury   
Event Description
It was reported that the patient had abdominal pain and nausea and the physician questioned if the patient¿s electrodes had been placed correctly. The patient was at 0. 75ma output current, and was asked to practice with the vns magnet providing 1ma stimulation once or twice a week. When the patient practiced with the magnet she experienced massive abdominal pain. The patient was ramped up to normal output current 1ma. Two weeks later, the patient had reduced continuous abdominal pain. The duty cycle was changed. Two weeks after that, the patient stated that the pain was reduced further but still not gone. The frequency was lowered from 30 hz to 20 hz. After a month, the patient still had pain and developed symptoms of diarrhea and no appetite. The patient¿s general practitioner had no assessment of the symptoms. The patient¿s device was disabled at the request of the patient and the pain resolved. X-rays were received and reviewed for the patient. Per the x-rays, the generator placement appeared to be normal in the left axillary chest area. Complete pin insertion was confirmed as the pin can be seen coming through the second connector block. The feed through wires, and the lead wire continuity appeared normal. The lead was observed in the neck and chest. Part of the lead appears to be behind the generator and could not be assessed. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. The electrodes are placed correctly, as there is a single wire present on the top electrode, and double wires present after the second electrode, indicating proper orientation. Note that the presence of a micro fracture and/or a lead discontinuity cannot be ruled out in the portion of the lead that is not visible in the provided images. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8445038
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #53 on: June 13, 2019, 03:24:10 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/01/2017
Event Type  Malfunction   
Event Description
It was reported that during diagnostic testing, high impedance was observed on the patient's vns. It was reported that there was no recent trauma to the area. Clinic notes were later received indicating that the patient strongly declined the disablement of the vns. The patient was referred for vns lead replacement surgery. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was later reported the patient was experiencing severe abdominal pain and was wondering if it was related to the vns leads and the high impedance. The patient presented to the physician's office due to the pain. No additional relevant information has been received to date.
 
Event Description
The patient underwent full vns replacement surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted devices and had discarded the products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7046309
Logged
Pages: 1 [2]  All   Go Up
Print
Jump to: