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Author Topic: Electrodes  (Read 116811 times)
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dennis100
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« Reply #90 on: March 12, 2012, 01:19:22 PM »

Event Date 07/15/2008
Event Type Injury
Patient Outcome Disability;
Event Description
It was reported to manufacturer that the vns pt had an mri scheduled to "check on the status of the patient's hearing. " the pt reportedly has been having some problems hearing in the left ear and the doctor wants to rule out that the electrodes that might be causing hearing problems. Attempts to obtain add'l info are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1120671
« Last Edit: September 25, 2015, 06:35:09 AM by dennis100 » Logged
dennis100
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« Reply #91 on: March 16, 2012, 02:03:30 PM »

Model Number 300-20
Event Date 10/01/2008
Event Type Malfunction
Event Description
It was reported that the pt's system mode diagnostics showed high lead impedance. The pt also had a small increase in seizures. Follow up with the nurse revealed that pt was sick and was recently toxic on lamictal. The nurse indicated that these could have attributed to her seizures and cannot really tell if it is because of vns therapy. The nurse also stated that the pt had fell previously and injured her neck and head. The level of seizures is same as pre-vns baseline. X-rays were reviewed by the mfr and it was observed that the negative electrode was off the vagus nerve, no obvious lead discontinuities were observed.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Negative electrode was observed to be off the vagus nerve.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1249827

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dennis100
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« Reply #92 on: March 26, 2012, 12:26:37 PM »

Model Number 300-20
Event Date 07/04/2009
Event Type Malfunction
Event Description
It was reported that high lead impedance readings were obtained during a routine office visit. The patient was in a pillow fight a few weeks prior to the high impedance readings being obtained. The end of service indicator was 10 years and the lead impedance was greater than 10,000 ohms. The patient's device was programmed off and lead revision will be discussed if there is an increase in seizure frequency. X-rays were sent to the manufacturer for review and it was found that the electrode may not be fully on the vagus nerve which could contribute to the high lead impedance event; however, the exact placement of the electrodes in relationship to the vagus nerve could not be determined from the x-ray view provided. No other obvious anomalies were observed that could be contributing to the report of high impedance. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1496319
« Last Edit: September 25, 2015, 06:35:34 AM by dennis100 » Logged
dennis100
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« Reply #93 on: March 26, 2012, 12:29:49 PM »

Model Number 302-20
Device Problem Failure to align
Event Date 06/23/2009
Event Type Malfunction
Event Description
Reporter indicated high lead impedance readings were obtained for a vns pt. The pt's seizures were also increased. The vns was disabled. The pt will be observed clinically with the vns disabled for now, and no vns revision surgery is currently planned. X-rays were reviewed by the manufacturer and no lead discontinuities were noted. However, it was identified that the vns electrodes are not in alignment; this is suggestive of one of the electrodes possibly not being secured to the vagus nerve. All attempts to the reporter for additional information have been unsuccessful to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Results - x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions - device failure is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1483313
« Last Edit: September 25, 2015, 06:36:04 AM by dennis100 » Logged
dennis100
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« Reply #94 on: March 26, 2012, 12:34:38 PM »

Model Number 302-20
Event Date 03/18/2009
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported that the electrodes of a vns patient's lead had begun to extrude through the skin of her right neck. Follow up with the patient's explanting surgeon revealed that the event was believed to be related to the patient being allergic to the material on the electrode. Though the patient has undergone several lead replacement surgeries due to patient manipulation, the patient's surgeon and treating vns therapy physician indicated that there had been no admissions of manipulation for this recent event.

Manufacturer Narrative
Patient physiology caused or contributed to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1397148
« Last Edit: September 25, 2015, 06:36:30 AM by dennis100 » Logged
dennis100
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« Reply #95 on: March 26, 2012, 12:38:02 PM »

Model Number 302-20
Event Date 01/29/2009
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported that the vns pt experienced swelling, wound dehiscence and allergic reaction at the electrode site. The pt was reportedly hospitalized and the events were resolved surgically. Diagnostics tests revealed proper device function. It was indicated that there was no pt manipulation that led to the events. It was also indicated that the pt did not have a medical history of allergies prior to vns. The events were determined to be due to wound dehiscence and definitely related to implantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1356631
« Last Edit: September 25, 2015, 06:36:45 AM by dennis100 » Logged
dennis100
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« Reply #96 on: March 26, 2012, 03:13:39 PM »

Model Number 102
Event Date 03/01/2010
Event Type Injury
Event Description
It was reported to the manufacturer that the vns pt's generator and part of the lead body were explanted due to an infection at the electrode site. It is unk if there was any pt manipulation or trauma at the device site that may have caused or contributed to the reported event. It is unk if cultures were taken to confirm the event. It is unk if there is infection also at the generator site. Good faith attempts to obtain add'l info regarding the reported event are currently underway.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1656292

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dennis100
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« Reply #97 on: June 08, 2012, 06:48:00 AM »

Event Date 04/06/2012
Event Type  Malfunction  
Event Description
Patient came to the or for a scheduled placement of a vagal nerve stimulator. Upon interrogating a new vns demipulse duo generator, it was discovered that the patient's existing vns electrode had failed as well as the vns generator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2591379
« Last Edit: September 25, 2015, 06:38:47 AM by dennis100 » Logged
dennis100
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« Reply #98 on: April 10, 2013, 03:18:01 AM »

Type of device: stimulator, vagal nerve, lead stimulator, vagal nerve
Device brand name:
Device manufacturer's name: Cyberonics, Inc.
Date of this report:(mm/dd/yyyy)    
05/23/2012
Describe the event or problem:    
Patient came to the OR for a scheduled placement of a Vagal Nerve Stimulator. Upon interrogating a new VNS Demipulse Duo Generator, it was discovered that the patient's existing VNS electrode had failed as well as the VNS generator.

The device(s) may have caused or contributed to: Potential for patient harm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=91287
« Last Edit: September 25, 2015, 06:39:47 AM by dennis100 » Logged
dennis100
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« Reply #99 on: April 10, 2013, 07:04:06 AM »

Type of device: stimulator, autonomic nerve, implanted for epilepsy
Device brand name: vns lead
Device manufacturer's name: Cyberonics, Inc
Date of this report:(mm/dd/yyyy)    
11/23/2011
Describe the event or problem:    
Pt had a vagus nerve stimulator placed in approximately 2005 or 2006. Pt has a seizure disorder & hydrocephalus; traumatic birth. Pt recently had an increase in his frequency and type of seizures. Battery was interrogated by Dr. and found to be completely depleted of voltage. Pt presented here recently for generator replacement but we found that the lead was completely disconnected from the wires up in the neck. It appeared that there was fluid that filled the channel indicating that this was longstanding. The wound had been closed and the patient sent home for a week while we arranged for a time to bring him back to do the longer surgery were we need to explore the vagus nerve and scar tissue and remove his broken lead and place a new one. Surgery recently completed for this procedure: dissection made down to the scar to the platysma, which we freed up and undermined. Worked way through scar just medial to the sternocleidomastoid muscle and identified the broken wires protruding upward. There was one anchor that was holding this electrode, which is the reason that this fractured at this point. There was no strain release loop left in the neck. We released the anchor, divided the lead, and then followed the lead down towards the vagus nerve. The jugular vein was identified and freed up as was the carotid artery. We worked our way on the more proximal and where there was not as much scar tissue and came down to the vagus nerve. We then worked our way cranially up the vagus nerve and then along the wire with a 15 blade until we came to the junction of the wire in the vagus nerve. Under loupe magnification, able to release the scar over the lead and then unwind the lead from around the nerve. There was quite a bit of scar tissue around the nerve and we were not sure how well a new electrode would work so we made sure we had a long segment of nerve, especially with some on the more proximal end to accept the local lead. The wound was irrigated, new lead wrapped around the vagus nerve carefully so as not to touch the wires and as well as its anchor. Slight strain releasee inferiorly and then looped the thick end of the electrode upward and secured it in 2 places with anchors under the paracervical musculature. We made a pocket for upward loop of the electrode. Tunneler to pass electrode. Tested lead; impedances were all good. Generator was zeroed out and will have to be set by Dr. some time in future. Wounds irrigated, sutured. Pt to recovery in stable condition.

The device(s) may have caused or contributed to: Potential for patient harm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=83904

« Last Edit: September 22, 2015, 02:30:52 AM by dennis100 » Logged
dennis100
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« Reply #100 on: April 10, 2013, 07:05:13 AM »

Type of device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Device brand name: VNS Demipulse
Device manufacturer's name: CYBERONICS, INC.
Date of this report:(mm/dd/yyyy)    
05/19/2010
Describe the event or problem:    
Patient has intractable epilepsy and an oligodendroglioma in the frontal lobe. Approximately 10 or 11 months ago, a Vagus Nerve Stimulator (VNS) was placed into position for her because her seizures have been poorly controlled with medical therapy. At the time of surgery, the impedance test of the electrode yielded a somewhat high impedance of 45. At the time the system was inspected very carefully because this value was somewhat unusual, and did not notice any excessive tissue affecting the nerve. After discussions with Cyberonics at the time, they recommended to continue with the implantation process, as the impedance was below the maximum threshold allowed. Patient did appear to have a response from the device. However, a while after implantation the impedance rose from values that had initially been postoperatively in the 7000 range to greater than 100,000. Subsequently, later on last year, the lead impedance was high enough that the device indicated it was not transmitting current properly. Despite this, patient has had what her family describes as a response to the device. It is, however, not entirely clear that is working for her, and in addition, the potential failure of the device has made it very difficult to obtain a MRI for her. Specifically, there is a concern that the electrode lead is broken.

The device(s) may have caused or contributed to: Potential for patient harm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=60522
« Last Edit: September 22, 2015, 02:31:52 AM by dennis100 » Logged
dennis100
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« Reply #101 on: April 10, 2013, 07:06:20 AM »

Type of device: lead, stimulator, vagus nerve stimulator, vagus nerve
Device brand name: VNS Therapy
Device manufacturer's name: Cyberonics, Inc.
Date of this report:(mm/dd/yyyy)    
07/29/2008
Describe the event or problem:    
Surgical Procedure for nerve stimulator battery failure. Pt presenting with chronic intractable seizures. The leads tested during the procedure were associated with high impedance and it was elected to replace the generator and the electrode stimulation system. The bipolar unit and lead were replaced.

The device(s) may have caused or contributed to: Not known

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=42264
« Last Edit: September 22, 2015, 02:32:55 AM by dennis100 » Logged
dennis100
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« Reply #102 on: April 10, 2013, 07:07:15 AM »

Type of device: Stimulator, Neurological, Vagus
Device brand name: VNS Therapy
Device manufacturer's name: Cyberonics, Inc
Date of this report:(mm/dd/yyyy)    
07/24/2008
Describe the event or problem:    
The 102 model generator seems to be fine. There was a high impedance reading which implies a break somewhere in the electrode lead, so this component had failed.

The device(s) may have caused or contributed to: Potential for patient harm

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=42090
« Last Edit: September 22, 2015, 02:34:03 AM by dennis100 » Logged
dennis100
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« Reply #103 on: April 10, 2013, 07:08:02 AM »

Type of device: Stimulator, Vagus Nerve
Device brand name: Cyberonics
Device manufacturer's name: Cyberonics, Inc.
Date of this report:(mm/dd/yyyy)    
03/02/2007
Describe the event or problem:    
Approximately nine months ago, the stimulator was reported to be malfunctioning after patient had a bad fall due to a seizure. After the fall, test results did not show any lead fracture, so a surgical revision of the stimulator itself was done. The stimulator was twisted about 360 degrees as was the electrode, which was also twisted and under tension. The positions were corrected and the electrode tested fine, so the system was left implanted in the patient. About three month later, the stimulator was again malfunctioning and could not be interrogated. A second surgical intervention was done and at this time it was noted that the top screw of the stimulator was totally loose although it had been secured during the previous intervention. At this time, the stimulator was removed and another device was implanted.

The device(s) may have caused or contributed to: Serious injury

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=30180
« Last Edit: September 22, 2015, 02:35:14 AM by dennis100 » Logged
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« Reply #104 on: April 04, 2014, 07:05:31 AM »

Event Date 01/20/2014
Event Type  Injury  
Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that the patient presented with an infection at the electrode site. The patient was admitted for explant of the vns system. The patient was prescribed antibiotics. It was reported that the infection was a result of vns implantation.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3672262
« Last Edit: September 25, 2015, 06:40:45 AM by dennis100 » Logged
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« Reply #105 on: April 04, 2014, 07:36:31 AM »

Model Number 105
Event Date 01/25/2014
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported that the vns patient began experiencing pain at the electrode site on the left side of her face and neck on (b)(6) 2014. Additionally, the patient had difficulty chewing during stimulation. According to the neurologist, the relationship between the reported pain and vns is increased sensitivity to vns stimulation due to unknown etiology. The pain appeared to occur with stimulation. To preclude a serious injury, the neurologist lowered the patient¿s programmed settings. Product information is not available due to hospital policy. The available programming history did include any diagnostic results.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677841
« Last Edit: September 22, 2015, 02:36:07 AM by dennis100 » Logged
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« Reply #106 on: June 06, 2014, 12:54:55 PM »

Model Number 302-20
Event Date 04/11/2014
Event Type Malfunction
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.

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.

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.

Event Description
The generator appears in the left abdominal area in an abnormal placement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3796059
« Last Edit: February 06, 2015, 07:29:13 AM by dennis100 » Logged
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« Reply #107 on: June 06, 2014, 01:19:57 PM »

Model Number 302-20
Event Date 04/14/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that prior to prophylactic generator replacement surgery, the vns patient¿s device showed high lead impedance. High impedance was not previously observed so no x-rays were taken and the device was not programmed off. The patient¿s generator and lead were replaced during the procedure. The surgeon noted that the electrodes were detached from the nerve. When replacing the generator, the surgeon was able to explant the generator and lead prior to opening the neck incision site. The explanted lead was fully intact and no other issues were noted. No patient manipulation or trauma was reported. The explanting facility discarded the explanted products; therefore, no analysis can be performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3802074
« Last Edit: September 30, 2015, 03:00:06 AM by dennis100 » Logged
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« Reply #108 on: June 23, 2014, 05:29:49 AM »

Model Number 302-20
Device Problems High impedance; Malposition of device
Event Date 12/14/2009
Event Type Malfunction
Patient Outcome Required Intervention
Event Description
It was reported that system diagnostics resulted in high lead impedance at f/u appointment. Add'l info provided through a company representative from the treating physician revealed no trauma or manipulation was reported that could have contributed to the event. X-rays were taken and further reviewed by the manufacturer which revealed the lead connector pin appeared to be fully inserted into the generator connector block and the filter feed-thrus appeared to be intact. Moreover, there was no lead behind the generator and no acute angles or discontinuities were observed in the visualized portion of the device. Add'l info was provided from the surgeon through a company representative as the pt was scheduled to have lead revision surgery due to the reported event. Info from the company representative revealed that during the surgery, the surgeon tried to explant the lead but there was a build up of fibrosis around the nerve and noted that the negative electrode was not around the vagus nerve. The surgeon informed the representative that the vagus nerve was partially sectioned and decided to explant both generator and lead as there was no possibility to re-implant a new lead due to the issue with the vagus nerve. At the moment, good faith attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-ray 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1585532
« Last Edit: September 25, 2015, 06:41:16 AM by dennis100 » Logged
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« Reply #109 on: July 04, 2014, 01:41:46 AM »

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

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899453
« Last Edit: September 25, 2015, 06:41:46 AM by dennis100 » Logged
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« Reply #110 on: July 30, 2014, 12:24:49 AM »

Device brand name: VNS Lead   
Device manufacturer's name: Cyberonics   
Date of this report:
(mm/dd/yyyy)
07/03/2011   
Describe the event or problem:
Patient underwent implantation of her Vagus Nerve Stimulator (VNS) ~3 years ago. Initially, it worked well to reduce the frequency and severity of patient seizures. Patient was able to use the device to help abort her seizures. Patient is now having events 1-2 times a week. She has begun to experience auras again. Interrogation of her VNS indicates high impedance, suggesting a malfunction. Chest XRay performed and suspect the lower contact on the nerve may be fractured. The contact is sitting at an odd angle on the nerve, and does not seem to be winding around the nerve the way it should.   

The device(s) may have
caused or contributed to: Potential for patient harm   

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=77103
« Last Edit: September 20, 2015, 01:22:47 PM by dennis100 » Logged
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« Reply #111 on: August 08, 2014, 02:18:49 AM »

Model Number 302-20
Event Date 06/11/2014
Event Type Malfunction
Event Description
It was reported that during generator replacement surgery due to end of service, the vns patient's device showed high impedence after the new generator was connected to the existing lead. Pin reinsertion was performed. The patient's lead was also replaced during the procedure. It was reported "surgeon said it looked like one of electrodes was off and possible broke wire". The explanted lead has been received for analysis. Analysis is underway, but has not been completed to date.

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

Event Description
Analysis of the lead was completed on 07/31/2014. The lead was returned in its entirety in three segments. Two lead fractures in the positive coil were identified just past the lead bifurcation. Pitting of the coil was identified near the fraction locations. Three abraded openings were identified (with fluid ingress) near the same area on both the positive and negative coil tubings. Note that compression of the tubing was identified near the bifurcation from what is likely sutures that were directly applied to the lead body.

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=3921584
« Last Edit: December 18, 2015, 09:49:29 AM by dennis100 » Logged
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« Reply #112 on: August 08, 2014, 02:19:13 AM »

Model Number 304-20
Event Date 06/10/2014
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the surgeon thinks that he inverted the lead electrodes during implant surgery on the patient the day prior. The surgeon indicated that he planned to fix the placement since the patient was still hospitalized. Additional information was received that the patient underwent lead revision where the position of the electrodes was corrected and the patient is fine. It was reported that x-rays confirmed the electrodes were initially placed incorrectly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3922681
« Last Edit: September 25, 2015, 06:42:15 AM by dennis100 » Logged
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« Reply #113 on: October 10, 2014, 06:35:22 AM »

Event Date 08/19/2014
Event Type Malfunction
Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the patient¿s lead electrodes were observed to be not in contact with the patient¿s vagus nerve. As result, diagnostic results showed high impedance. It was noted that the patient¿s vagus nerve was very thin. No known surgical interventions for the reported high impedance and electrode placement have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4096581
« Last Edit: December 16, 2015, 10:55:07 AM by dennis100 » Logged
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« Reply #114 on: November 07, 2014, 12:47:20 AM »

Model Number 102
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported that the vns patient had been experiencing an increase in seizures for several months. The patient stated that he was also having pain at his lead electrode site. Attempts for additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210557
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« Reply #115 on: November 07, 2014, 12:47:59 AM »

Model Number 303-20
Event Date 08/03/2014
Event Type Injury
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 due to painful stimulation in her neck which was occurring every 10 minutes for the past month. During the patient¿s last office visit in (b)(6) 2014, the device output current was increased from 2. 75ma to 3. 25ma. The patient¿s device was tested during the visit and diagnostic results showed normal device function. The patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to electrode failure and pain. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. The patient has not been re-implanted to date to allow sufficient time to let her vagus nerve heal.

Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210450
« Last Edit: December 14, 2015, 10:38:30 AM by dennis100 » Logged
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« Reply #116 on: November 07, 2014, 09:27:14 AM »

Model Number 105
Event Date 07/22/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient underwent surgery on (b)(6) 2014 to explant his generator and lead. The patient had been scratching at his cervical wound site which subsequently led to extrusion of the electrode. It was noted that the patient had a history of combativeness, aggressiveness, and self-mutilating behavior. The patient went to the er where approximately 6cm of the patient¿s lead was found to be visibly extruding from the approximate 6mm opening of the patient¿s wound. There was no purulence but the patient was sent for surgery due to risk of infection. During explant, granulation tissue was found at the area of dehiscence and a significant amount of scarring was noted within the patient¿s neck. The extruding portion of the patient¿s lead was cut and discarded. Samples were taken for cultures and the patient¿s wound was cleaned and irrigated. The patient has not been re-implanted to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4131361
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« Reply #117 on: December 05, 2014, 03:23:51 AM »

Model Number 302-20
Event Date 01/01/2005
Event Type Injury
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. However, lead electrodes were noted to be inverted on the nerve.

Event Description
It was reported that the patient had vns explant in 2006 due to cardiac episodes and painful stimulation. The patient had previously had generator replacement on (b)(6) 2006. Review of the generator programming history revealed that the device was programed off on (b)(6) 2007. The explant therefore occurred sometime after that time. The patient had vns re-implant surgery on (b)(6) 2014. During surgery, the surgeon noted that the old lead electrodes were inverted on the vagus nerve (with the positive and negative electrodes inverted). It was reported that in 2005, the patient had a cardiac episode and was hospitalized for bradycardia. Additionally, the patient had painful stimulation. As a result, the device was turned off, and the generator and a portion of the lead in the chest area was explanted. Review of programming history in-house reveals the device was programmed off on (b)(6) 2007. Follow-up with the patient's treating neurologist revealed that there is only limited information regarding the events, as the patient was treated by a different physician at the practice at the time of the events and that physician no longer works at the practice. The currently treating physician's recollection is that there were "big problems" with getting the patient regulated which would be explained by the inverted electrodes, per the physician. The explanted portion of the lead from surgery on (b)(6) 2014 was received by the manufacturer for analysis. Note that a large portion of the lead assembly (body); including the connector pin / boot section with model and serial number tag and the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuity in the returned portion of the device which may have contributed to the stated allegations. Additionally for the explanted generator on (b)(6) 2006, analysis was completed. Based on the battery life analysis, the pulse generator approached a normal end of life condition. In addition, the pulse generator was operating at an increased duty cycle (71%) and, as defined in the physician¿s manual, this will deplete the battery faster than a low duty cycle; this may have been a contributing factor. The reported condition of erratic stimulation at that time was not verified in the laboratory. Delivered generator output across an electrical load confirmed a steady output voltage consistent with programmed parameter settings. There were no signs of variation in the output signal. The pulse generator would not interrogate, therefore was opened. The measured battery voltage was below the low battery operation level specified for the pulse generator, which indicates that the pulse generator had reached the end of life. These measurement in the lab demonstrate appropriate current consumption for the device, resulting in normal battery depletion. No performance anomalies were noted.

Event Description
The surgeon's office reported that the patient had explant surgery on (b)(6) 2008. It was also reported that the explanted generator and portion of the lead explanted at that time were discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4233217
« Last Edit: December 14, 2015, 10:37:32 AM by dennis100 » Logged
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« Reply #118 on: February 06, 2015, 07:31:13 AM »

Model Number 302-20
Event Date 12/01/2014
Event Type Injury
Event Description
It was reported that the physician underwent explant of the vns and it was noted that the lead electrodes had been "scorched" on the patient's nerve. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4394209
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« Reply #119 on: March 06, 2015, 03:20:14 AM »

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

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

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