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Author Topic: Electrodes  (Read 109880 times)
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dennis100
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« Reply #30 on: May 18, 2011, 06:52:02 AM »

Event Date 12/01/2007
Event Type Malfunction
Patient Outcome Other;
Event Description
Initial reporter indicated that the patient had not been seen for over a year. It was reported that the patient had an increase in seizures in last six months or more. No pain with stimulation reported in neck area. Diagnostics were performed that showed high lead impedance indicating a possible lead malfunction. Patient x-rays reviewed by physician "showed possible problem with electrodes, pin seemed in place. Opinion of surgeon, is child has grown a lot and he is considering what he could do to address the problem reloops in the neck". The patient may be scheduled for lead revision

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=973217
« Last Edit: September 25, 2015, 06:15:21 AM by dennis100 » Logged
dennis100
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« Reply #31 on: May 18, 2011, 12:52:59 PM »

Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that pt was undergoing exploratory surgery, because pt was having "problems" with vns therapy. During the procedure the lead was accidentally cut by the surgeon. Additionally, one of the electrodes was found to be off of the nerve. During the same procedure, the pt's lead and generator were replaced, and the explanted products were returned to mfr for analysis. To date that analysis is not yet complete. Good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1021317
« Last Edit: September 25, 2015, 06:15:43 AM by dennis100 » Logged
dennis100
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« Reply #32 on: May 19, 2011, 02:49:12 AM »

Event Date 01/18/2008
Event Type Malfunction
Event Description
It was reported that the vns pt had surgery where the generator was replaced due to end of service, and the lead was replaced due to an unk reason. Attempts to obtain the reason for lead replacement have been made, but have been unsuccessful to date. The lead and generator were returned to mfr for analysis. Analysis of the generator revealed that the generator was not found to be at end of service (eri flag set to no) and there were no performance anomalies observed during testing. Analysis of the lead was completed and a lead discontinuity was confirmed on the quadfilar coil of the closest (white) helical electrode (positive to the pulse generator). Scanning electron microscopy was performed on the quadfilar coil break and identified the area as having evidence of a stress-induced fracture (fatigue appearance) with mechanical damage with fine pitting on the surface of the coil. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. An abraded opening was observed, found on the outer silicone tubing, and most likely provided a leakage path for what appeared to be remnants of dried body fluid found inside the outer silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. There were no performance anomalies or discontinuities noted on the remaining portion of the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1028710
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dennis100
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« Reply #33 on: May 19, 2011, 02:49:56 AM »

Event Date 04/23/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a vns patient's "electrodes have slipped into the sternocleidomastoid muscle. " the event was reportedly confirmed via x-rays reviewed by the medical professional. Normal and system diagnostics are within normal limits. There was no trauma or patient manipulation of the device. Revision surgery is likely. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051739
« Last Edit: September 25, 2015, 06:16:06 AM by dennis100 » Logged
dennis100
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« Reply #34 on: May 19, 2011, 02:50:45 AM »

Event
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« Reply #35 on: May 19, 2011, 05:16:30 AM »

Event Date 05/20/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a pt underwent generator replacement surgery due normal end of svc. X-rays and ct taken prior to surgery indicated that the pt's leads were not attached to the vagus nerve. The pt stated she was never able to perceive stimulation. During the surgery, the surgeon noted the old lead was attached to the sternocleidomastoid and not the vagus nerve. The pt underwent a complete revision. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1063419
« Last Edit: September 25, 2015, 06:16:42 AM by dennis100 » Logged
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« Reply #36 on: May 19, 2011, 06:22:55 AM »

Event Date 05/12/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns patient underwent generator replacement surgery due to normal end of service. Pre-operative x-rays noted the leads were not attached to the nerve. Diagnostic testing was within normal limits. During surgery, the surgeon noted the negative lead and anchor tether were attached to the nerve but the positive electrode was not. The surgeon cleaned up some scar tissue and then re-attached the negative electrode to the vagus nerve. The generator was replaced as scheduled, and diagnostics confirmed proper device function. Good faith attempts to obtain additional information have been successful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059653
« Last Edit: September 25, 2015, 06:17:04 AM by dennis100 » Logged
dennis100
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« Reply #37 on: May 19, 2011, 06:23:34 AM »

Event Date 05/08/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a patient will have lead revision surgery due to pain at the electrode site. The patient has stated "the lead fell off the nerve". Attempts for more information from the reporter and product information are pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1057679
« Last Edit: September 25, 2015, 06:17:22 AM by dennis100 » Logged
dennis100
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« Reply #38 on: May 19, 2011, 10:16:20 AM »

Event Date 06/13/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns pt has pain in her neck and the lead seems to be moving. The pt is very skinny so lead can be seen protruding out of the patient's neck. Diagnostic test were all normal. The manufacturer reviewed x-rays and no strain relief bend or loop were visualized. Additionally, the negative electrode does not appear to be in vertical alignment with the positive electrode as typically seen. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1080752
« Last Edit: September 25, 2015, 06:17:36 AM by dennis100 » Logged
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« Reply #39 on: May 19, 2011, 10:17:18 AM »

Event Date 06/27/2008
Event Type Malfunction
Event Description
Reporter indicated vns was opened, but was not utilized because it was defective. F/u with the surgeon revealed the lead was placed in the pt's vagus nerve, but the electrode keep falling off of the nerve. A second lead was used and everything worked well. The handheld has been returned to the mfr and is pending product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1081542

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dennis100
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« Reply #40 on: May 20, 2011, 03:07:48 AM »

Event Date 01/01/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated a vns pt's "electrodes have slipped into the sternocleidomastoid muscle. " the pt's name was not provided. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1102472
« Last Edit: September 25, 2015, 06:17:58 AM by dennis100 » Logged
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« Reply #41 on: May 21, 2011, 12:50:48 AM »

Event Date 08/01/2008
Event Type Malfunction
Event Description
It was reported that patient's last diagnostics test showed a high lead impedance. It was also indicated that the patient stopped feeling stimulation about three months ago and a mild intensification of seizures occurred. X-rays were reviewed by the physician and he indicated that one electrode (distal to head) is partially uncoiled and displaced. The line containing electrodes does not lie parallel to the normal location of vagus nerve. The patient's device is programmed off and electrode replacement is planned in case of further worsening of epilepsy. Follow up with nurse stated that no trauma occured and x-rays have been sent to manufacturer for further review. No additional information is available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1350383

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dennis100
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« Reply #42 on: May 21, 2011, 12:51:27 AM »

Event Date 09/18/2008
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the pt had her vns device turned off for three weeks, and when the device was turned back on, she began experiencing pain/burning sensations at the chest site. She also experienced extreme shortness of breath during system diagnostics test and magnet use. Diagnostic tests showed vns to be functioning properly. The pt's device was programmed off. X-rays were sent to the mfr for review. The negative electrode did not appear to be in the typical helical orientation. Additionally, the electrodes were not aligned vertically. The strain relief of the lead body at the neck did not appear to be adequate. No tie-downs were visualized. No obvious lead discontinuities were observed. The pt has currently been referred for a surgical consult. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1212658
« Last Edit: September 25, 2015, 06:18:19 AM by dennis100 » Logged
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« Reply #43 on: May 23, 2011, 05:50:50 AM »

Event Date 03/24/2009
Event Type Malfunction
Event Description
Reporter indicated a vns therapy patient underwent generator replacement surgery. During the surgery, the surgeon noted the lead was "all balled up" and off the nerve. The surgeon elected to explant the entire vns therapy system. At a later date, the patient underwent vns therapy implant surgery. The explanted products were returned to the manufacturer and are pending analysis. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1421314


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dennis100
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« Reply #44 on: May 23, 2011, 05:51:17 AM »

Event Date 01/01/2009
Event Type Malfunction
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that the pt was in the hosp due to a fluid build-up around his generator. The pt had both the generator and lead removed. During the procedure, what appeared to be pus was found inside of the lead, and the negative electrode had "disintegrated" as per the company representative's account. During the procedure, cultures of the site were taken and were negative for an infection, but the surgeon still believed that the fluid build-up could be due to an infection that started during the pt's previous prophylactic generator replacement surgery, as the pt had been on multiple antibiotics since the beginning of the hospitalization. During the removal procedure, it was noted that there were metallic bits within the fluid that was surrounding the generator. Attempts for more info were unsuccessful. The lead has been returned to the manufacturer, along with the metallic bits found in the fluid surrounding the generator, for analysis, but analysis has not yet been completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1426599
« Last Edit: September 25, 2015, 06:18:37 AM by dennis100 » Logged
dennis100
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« Reply #45 on: May 23, 2011, 05:51:45 AM »

Event Date 01/01/2009
Event Type Malfunction
Event Description
Reporter indicated that the pt underwent full revision surgery, after having a generator revision surgery approx a month earlier. At the follow-up visit following the initial surgery, high impedance was noted, which prompted the full revision surgery. Once the lead was removed during the full revision surgery, it was noted that there was an abraded opening in the silicone sheath surrounding the lead coils. The surgeon was unsure if this occurred due to pulling when removing the lead or not. A portion of the lead was returned to the manufacturer for analysis. Analysis found a lead fracture in the returned lead portion. Pitting and electro etching were found at the site of the fracture which is evidence that the fracture occurred outside of surgery and that stimulation was present for a period of time while the coils were fractured. The reported abrasion in the silicone sheath was also found in the returned lead portion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1424784
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dennis100
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« Reply #46 on: May 24, 2011, 01:01:42 AM »

Event Date 01/01/2008
Event Type Malfunction
Event Description
It was initially reported that the vns pt had their lead and generator replaced due to an unk reason. Further follow up with the surgeon revealed that the pt had the lead replaced due to a lead fracture that was visualized on x-rays, and the generator was replaced at that time as well. Further follow up with the referring neurologist revealed that the pt was a new pt to the physician and when the device was initially interrogated and tested, high lead impedance resulted. The physician disabled the device at that time, and referred the pt for x-rays and to the surgeon to replace the device. The radiologists x-ray assessment indicated that there was "a disconnect of the electrodes in the neck". There was no report of manipulation of the device or trauma. The explanted lead and generator were discarded following surgery, and the devices are therefore not available to be returned to manufacturer for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1467996
« Last Edit: September 25, 2015, 06:18:58 AM by dennis100 » Logged
dennis100
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« Reply #47 on: May 31, 2011, 11:04:05 AM »

Event Date 01/01/2010
Event Type Malfunction
Event Description
During generator replacement surgery due to generator battery depletion, when the new generator was connected to the existing lead, high lead impedance resulted. The surgeon opened the neck incision to explore the cause of the high lead impedance, and it was noted by the surgeon that "one of the electrodes was detached from the nerve and there was also a lead fracture. " the lead was subsequently explanted and a new lead was implanted. The explanted lead and generator were discarded after the surgery, and are therefore not available to be returned to manufacturer for additional analysis. Further follow up with the treating physician revealed that the last diagnostic test was done in (b) (6)2009, which revealed normal device function. The device was not able to be interrogated at subsequent follow up visits that took place in (b) (6)2009, and again in (b) (6)2010 prior to surgery, which was believed to be due to battery depletion. There were no x-rays taken prior to surgery to assess the continuity of the device.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1619798
« Last Edit: September 25, 2015, 06:19:25 AM by dennis100 » Logged
dennis100
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« Reply #48 on: May 31, 2011, 11:04:34 AM »

Event Date 01/20/2010
Event Type Malfunction
Event Description
It was reported that high lead impedance was read in system diagnostics during a follow up visit with the treating neurologist. The patient had reported an assault and trauma to the neck area in (b) (6) 2009. System diagnostics were fine (ok/ok/1/no) in (b) (6) 2009 after the incident and the high lead impedance (7/limit/high/no) was encountered on (b) (6) 2010 after performing both a system and normal mode diagnostic test. The device was programmed off by the neurologist and the patient was recommended for x-rays. X-ray review from the manufacturer revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. Furthermore, no acute angles or discontinuities were observed in the visualized portion of the device, though a small portion of the lead behind the generator could not be visualized or assessed. The patient's positive electrode appeared to be misaligned with the negative electrode, which may be due to electrode/nerve detachment. A clinic note was received from the office of the treating neurologist at the time of the incident which indicated the patient was grabbed by the throat and after he was released, he felt the lead was moved and was hoarse due to the trauma. Follow up with the treating neurologist revealed the patient was doing well with no adverse events and revision surgery had been scheduled and was likely to occur.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1613594

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dennis100
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« Reply #49 on: May 31, 2011, 11:05:00 AM »

Event Date 03/01/2010
Event Type Malfunction
Event Description
It was initially reported by the physician that the pt was at their office and when she performed system diagnostics, she got high lead impedance. This was only the second time he had seen the pt in his office. Last time he saw him was in july but did not perform any diagnostics at that time. Pt's device was turned off at that time. Physician did not know if any pt manipulation or trauma had occurred. He stated pt had shown no change in seizure frequency. X-rays were sent to manufacturer for further review. Review of the x-rays showed that the electrodes appeared to be off the nerve which could be contributing to the high lead impedance; however, a lead discontinuity cannot be ruled out in the part of the lead that could not be assessed. Pt's last good diagnostics were obtained in (b)(6) 2007. Additional information received stated that the pt had a full revision surgery. Good faith attempts to obtain explanted products for analysis have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1674177
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dennis100
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« Reply #50 on: June 01, 2011, 11:22:07 AM »

Event Date 01/01/2009
Event Type Malfunction
Event Description
It was initially reported by the site that the pt was taken into surgery for implanting a nerve stimulator. Pt is implanted with vns and after the implant of nerve stimulator, the surgeon noticed high lead impedance on system diagnostics. X-rays were taken and sent to mfr for review. The improper connector pin insertion is most likely contributing to the high lead impedance. However, a lead discontinuity on the portions of the lead body that could not be assessed cannot be ruled out. The electrodes were also placed inverted on the vagus nerve. No manipulation or trauma was reported and pt showed increase in seizures in the past week or so. Good faith attempts to obtain additional info have been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658414
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dennis100
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« Reply #51 on: June 01, 2011, 11:24:25 AM »

Event Date 01/01/2003
Event Type Malfunction
Patient Outcome Required Intervention;
Event Description
It was reported to the mfr that the vns pt has been experiencing an increase in seizure activity. It is unk if the increase is above pre-vns baseline. The pt's generator (102r) was believed to be at the end of service, therefore, the pt was sent for generator replacement surgery. During surgery, the new generator was attached to the existing lead body and diagnostic tests were performed that resulted in high lead impedance. Troubleshooting did not resolve the event; therefore, a full revision was performed. During the explant of the existing lead body, it was found that the negative electrode was off the nerve and encapsulated in scar tissue. The positive electrode and the anchor tether remained on the nerve. X-rays were not taken prior to surgery to assess the integrity of the device as an issue with the lead was not suspected. Review of programming history revealed that the pt's previous generator (100c) showed high lead impedance with the same lead body in 2003. Diagnostic tests following that date or test results from generator revision surgery are not available to confirm the resolution of the high lead impedance event. Therefore, the cause of the increase in seizure activity is unk at this time. Good faith attempts to obtain the explanted products back for analysis and add'l info regarding the reported event are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1659943
« Last Edit: September 25, 2015, 06:19:53 AM by dennis100 » Logged
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« Reply #52 on: June 01, 2011, 11:26:03 AM »

Event Date 04/01/2010
Event Type Malfunction
Event Description
It was initially reported by the physician that the pt showed high lead impedance on system mode diagnostics. Pt's device was turned off and pt was referred to the surgeon for a full revision surgery. Additional info received stated that the pt had a full revision surgery. While replacing the lead, the surgeon noticed that one of the electrodes was off the vagus nerve. Surgeon did not visualize any breaks. Pt was implanted with a new lead and diagnostics on the new device showed everything working within normal limits. Good faith attempts to obtain explanted products for analysis has been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1701618
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« Reply #53 on: June 03, 2011, 03:45:49 AM »

Event Date 04/13/2010
Event Type Malfunction
Event Description
Reporter indicated a patient's vns electrodes were displaced. The vns was disabled, and the reporter indicated the patient would be sent for a surgical eval. X-ray films were requested, but ct scans were sent to the mfr which were unable to be interpreted. All further attempts to the reporter for add'l info and the plan of care have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1733184

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« Reply #54 on: June 04, 2011, 03:19:02 AM »

Event Date 01/01/2007
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by pt that while she was driving, she jerked her neck and the leads were protruding from her neck. She had to undergo an exploratory surgery to identify the cause of protruding. Pt also stated that during the surgery, the surgeon told her that the leads had migrated and they were off the nerve. Good faith attempts to obtain additional info have been made, but no response has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1889149
« Last Edit: September 25, 2015, 06:20:19 AM by dennis100 » Logged
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« Reply #55 on: June 06, 2011, 11:46:00 PM »

Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient was scheduled for explant for unknown reason after less than one year of service. Further follow-up revealed that the patient had experienced an increase in seizures "by 20 times" after vns implant and has subsequently required 22 emergency room visits for seizure activity. The patient also reported constant worsening of asthma, shortness of breath, and burning in the throat. The patient's device was programmed to off five days prior to explant. Device diagnostic testing on day of explant was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator was not at end of service. X-rays on day of explant surgery revealed that the location of the lead was inconsistent with normal vns lead placement. There were no tie-downs used, the lead was in disarray, not aligned in the normal parallel orientation, and was located lower than normal. It was reported that the lead electrodes were not wrapped around the vagus nerve. Poor implant technique at time of initial implant is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461860
« Last Edit: September 25, 2015, 06:20:45 AM by dennis100 » Logged
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« Reply #56 on: June 07, 2011, 04:00:19 AM »

Event Date 01/01/2003
Event Type Malfunction
Event Description
Reporter indicated that vns pt underwent lead replacement surgery approx 5 months post-implant due to lead break. The pt could no longer feel stimulation just 3 months post-implant and that the neck site in the area of the lead was "raised and ridgey". Both device diagnostic testing and evoked potential monitoring was within normal limits, indicating proper device function. The raised area at the neck site had reportedly gone away prior to revision surgery. The pt's caregiver indicated that the pt did not have full range of motion after vns implant and that the pt kept their head down and could not look up due to something in their neck. X-rays reviewed by physician revealed a discontinuity in the ncp system. During lead replacement surgery, the lead electrode was noted to be twisted eight or ten times near the generator and it was believed that the generator had been manipulated through the skin by the pt. There was tension in the neck, but the strain relief was still present. The lead was clearly broken, though the pt denies manipulating the device through the skin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=478617
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« Reply #57 on: June 08, 2011, 12:12:50 PM »

Event Date 06/03/2003
Event Type Malfunction
Event Description
Vns pt was scheduled for reimplant because treating neurologist believes that the lead electrodes may not be on the vagus nerve. It was reported that the pt has never felt stimulation. Device diagnostic testing was within normal limits, indicating proper device function. Device settings were increased, after which the pt felt stimulation. Device settings were then decreased back to prescribed levels.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612015
« Last Edit: September 25, 2015, 06:21:11 AM by dennis100 » Logged
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« Reply #58 on: June 09, 2011, 12:17:03 AM »

Model Number 300-20
Event Type Malfunction
Event Description
Reporter indicated that patient's neurologist suspects that one of the lead electrodes is no longer on the vagus nerve. The patient reports a recent increase in seizure activity as well as a feeling of neck tightness with stimulation. The patient's device was subsequently programmed to off, resulting in loss of therapy. It was reported that prior to the incident, the patient was receiving efficacy from the vns therapy. The patient was referred to surgeon for evaluation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=611886
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« Reply #59 on: June 13, 2011, 12:14:59 PM »

Event Date 01/01/2006
Event Type Malfunction
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the patient experienced periods of constant jaw pain. The pain was later reported to be only during stimulation and radiating from her throat and neck to her chest. Diagnostic test results were within normal limits and review of x-rays did not reveal any lead discontinuities, although inadequate strain relief was observed. The patient underwent revision surgery, where both the generator and the lead were replaced. The explanting surgeon indicated that the original lead electrodes were not attached to the vagus nerve and were instead encapsulated in scar tissue. It is unk whether the electrodes were ever properly attached to the vagus nerve or whether they slipped off the nerve after implant. Product analysis did not reveal any device failure of the lead, although the electrode portion of the lead was not returned for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=948543
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