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Author Topic: Numbness/Tingling  (Read 25972 times)
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dennis100
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« on: December 26, 2015, 05:55:52 AM »

Model Number 103
Device Problem Device operates differently than expected
Event Date 12/08/2010
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient believed someone had hacked into her device and was experiencing difficulty with stimulation. The patient did not have any seizures since vns. The patient wanted to have her device removed. The patient¿s device was programmed off on 04/02/2014. The neurologist stated that there were no issues with the patient¿s device and that the patient was suffering from some type of psychotic disorder. The patient continued to have issues after her device was programmed off. The neurologist stated that the patient¿s issues were not related to vns attempts for additional relevant information were made but have been unsuccessful to date.

Event Description
Additional information was received from the neurologist stating that vns patient¿s psychosis was related to the event. The patient was having fixed delusions. The patient¿s device was disabled on (b)(6) 2014. The patient was referred for surgery but no know interventions have occurred to date. The patient believed that the police were accessing her device and harassing her.

Event Description
Additional information was received that the patient is able to feel the stimulation on demand when the magnet is swiped across the generator in spite of this device being disabled by the neurologist. It is unknown if the magnet mode stimulation was also disabled. Attempts for additional relevant information were unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient stated that she feels tingling in her heels, legs, and groin when she is around cell phones or technology. She said that the magnet is not turning off her device. She said she sleeps with the magnet taped on and she said that it is still stimulating. She said the device is stimulating erratically. The patient stated that her physician does not entirely believe that she is feeling these things. Per the patient, diagnostics come back fine, and the doctor says the device is working properly. She stated that the device turns on and off at "suspicious intervals". She said that the vns has worked really well for her, and these events began in (b)(6) 2013. The patient¿s new following physician will not provide information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3483718
« Last Edit: February 23, 2016, 02:48:06 AM by dennis100 » Logged
dennis100
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« Reply #1 on: December 27, 2015, 11:32:56 AM »

Model Number 102
Event Date 09/01/2013
Event Type Malfunction
Event Description
On (b)(6) 2014 it was reported that the patient underwent generator replacement due to end of service on (b)(6) 2014. The lead impedance after surgery was noted to be within normal limits. Attempts were made for the return of the explanted product but it has not been received to date.

Event Description
It was reported that device diagnostics show that the generator is not able to deliver the programmed settings. The patient reports tingling in the chest with stimulation. The physician indicated that the that the patient would be referred for x-rays. It is unknown if x-rays will be sent to manufacturer for review. It was reported that the patient has had good results from vns therapy. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

Event Description
The vns patient¿s current device settings were provided. A battery life calculation using the available programming history showed approximately 0. 04 years until eri = yes. No known interventions have occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3376824
« Last Edit: February 23, 2016, 02:48:25 AM by dennis100 » Logged
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« Reply #2 on: December 28, 2015, 01:34:46 AM »

Model Number 103
Event Date 03/01/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient's device was explanted due to the device shocking her. It was unknown if the device was replaced and if the explant was to preclude a serious injury or for patient comfort. Previously it had been reported that the patient was receiving a shocking/tingling sensation from the area of the generator; however, no interventions had been taken or planned at that time. The physician also reported that patient would occasionally receive ¿jolt¿ from area where electrodes are placed. The patient was involved in bicycle crash and received trauma to generator site and the neck in the emergency room. The shocking symptoms began soon after. The system diagnostics were observed as normal, and x-rays did not identify a problem. The device was disabled with the magnet, and the symptoms subsided. Diagnostics were run again in the presence of the physician and tc which returned no indication of lead break. The generator¿s regular stimulation was turned off and magnet stimulation was left on. The physician opted to leave regular stimulation off for the time being and may consider sending patient to surgeon later for replacement to determine if generator damaged. Follow-up showed that the patient was alert and able to recount the details that led to the buzzing/generator jolts on (b)(6) 2013. It was unknown when the event began and no other information was provided. The explanted device was returned and product analysis was performed. It was found that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 139 volts (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccum consumed memory locations revealed that 29. 232% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis performed on the returned lead portions. Note since a portion of the lead body was not returned for analysis a complete evaluation could not be performed on the entire lead products. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3341291
« Last Edit: February 23, 2016, 02:48:43 AM by dennis100 » Logged
dennis100
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« Reply #3 on: December 28, 2015, 10:58:07 AM »

Model Number 103
Event Date 10/17/2013
Event Type Injury
Event Description
On (b)(6) 2013, this vns patient reported that he began having severe swallowing issues two weeks prior and was taken to the hospital. The patient was told that he may have had a stroke as he had numbness on the left side of his face. The patient¿s primary care physician stated that he may need his vns settings adjusted to help with the swallowing issues. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3484481
« Last Edit: February 23, 2016, 02:48:59 AM by dennis100 » Logged
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« Reply #4 on: December 28, 2015, 10:58:30 AM »

Model Number 103
Event Date 01/01/2013
Event Type Injury
Event Description
Attempts for relevant information have been unsuccessful.

Event Description
Clinic notes dated (b)(6) 2013 were received on (b)(6) 2013. The notes indicated that the patient had canceled an appointment in the past where she was going to follow-up about numbness in the right side of the body. She was not able to attend that appointment because she was in the hospital, and it was believed that the patient had a stroke.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3545751
« Last Edit: February 23, 2016, 02:49:13 AM by dennis100 » Logged
dennis100
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« Reply #5 on: December 29, 2015, 08:21:57 AM »

Model Number 102
Event Date 03/29/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 indicates that the patient was seen for follow up after vns placement performed on (b)(6) 2013. The patient reports hoarseness that waxes and wanes, and is concerned about "feeling the wiring up in the lower neck". The patient had some throat, tongue, and perioral numbness a couple of days ago, but it resolved. The notes also mention that the patient has a past medical history or sleep apnea. Clinic notes dated (b)(6), 2013, indicate that the patient feels like something is "stuck in his throat when the vns is on" and feels like he is choking while eating. The patient went in for revision surgery on (b)(6) 2013, where the lead, and possibly the generator, were revised or repositioned. The devices were not removed and no new devices were implanted. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
Operative notes from the patient¿s (b)(6) 2013 surgery were received. Surgical diagnoses included painful malpositioned vagal nerve stimulator lead. During surgery, robust fibrotic scar tissues was found with suture tie downs dislodged. The note stated that the patient tolerated the initial implant procedure well; however, he began to complain of left neck superficial pain at the site of palpable scar tissue and lead. Initial non-operative management included massage and external repositioning, which were both unsuccessful. X-rays reportedly showed no fracture of the lead. During surgery, the suture tie-downs were noted to have become dislodged. The suture tie-downs were temporarily removed, and the lead was freed as much as possible and then re-secured. The lead course was re-routed to allow gentle curve with strain relief loop recreated and suture tie downs secured to muscular fascia. Scar tissue was revised.

Manufacturer Narrative

Event Description
Operative notes from the patient¿s (b)(6) 2013 implant surgery were received. The procedure was completed with minimal blood loss. No adverse events or complications were noted in the operative report. It was noted that the programming wand was used to interrogate and test the generator and lead, and they tested well.

Event Description
Attempts for additional information did not provide information regarding the events. The only information returned was that the patient did not have a history or diagnosis of osa.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3292790
« Last Edit: February 23, 2016, 02:49:30 AM by dennis100 » Logged
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« Reply #6 on: December 31, 2015, 01:23:54 AM »

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

Manufacturer Narrative
Device malfunction is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861962
« Last Edit: February 23, 2016, 02:49:47 AM by dennis100 » Logged
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« Reply #7 on: January 03, 2016, 03:23:14 AM »

Model Number 102
Event Date 04/04/2013
Event Type Injury
Event Description
On (b)(6) 2013 this vns patient reported that her battery was low and that there had been no indication that it would occur. The patient was waiting to see a surgeon and had been experiencing pain, discomfort, and blackout spells. The patient reported experiencing aura-like sensation, stomach pain, urinary incontinence, tachycardia, and had blacked out once since generator had become depleted. Clinic notes dated (b)(6) 2013 stated patient reported that vns seemed to stop working on (b)(6) 2013. The patient attempted swiping the magnet several times on (b)(6) 2013, which only barely activated the vns device. The patient attempted a swipe on (b)(6) 2013, which produced tingling in the scalp and tachycardia almost instantly. The patient took 2 lorazepams and went to the emergency room. The patient had been prescribed potiga several months prior, but never started as the potential side effects scared the patient and the patient felt that seizures were under control. Additionally, the patient had obtained a bottle of clonazepam several months prior and overdosed on it while also taking regularly prescribed lorazepam on (b)(6) 2013. At the (b)(6) 2013 visit, the vns was successfully interrogated, programmed and diagnostics were performed. The results were provided. The patient was referred for vns replacement surgery. On (b)(6) 2013 the patient reported that she went to the emergency room the night of (b)(6) 2013 because of complications. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3106486
« Last Edit: February 23, 2016, 02:50:03 AM by dennis100 » Logged
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« Reply #8 on: January 04, 2016, 12:56:31 PM »

Model Number 102
Event Date 07/01/2012
Event Type Injury
Event Description
The patient¿s explanted generator will not be returned for analysis due to the hospital¿s privacy policy.

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3065662
« Last Edit: February 23, 2016, 02:50:18 AM by dennis100 » Logged
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« Reply #9 on: January 04, 2016, 12:56:54 PM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient was experiencing shortness of breath and numbness radiating down their arm along with chest pain and pressure, not in the area of the vns. When patient feels these symptoms, patient "takes some nitro" and the symptoms resolve. Treating neurologist indicated that the reported event was not related to the vns therapy and may be related to the musculoskeletal or cardiac system. The patient was referred to a cardiologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522091
« Last Edit: February 23, 2016, 02:50:35 AM by dennis100 » Logged
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« Reply #10 on: January 07, 2016, 06:51:38 AM »

Model Number 102
Event Date 02/13/2013
Event Type Injury
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the previous night the patient was experiencing a tingling and stinging sensation about the generator and that it is "not working at all". The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. The manufacturer's consultant reported that he checked the patient's device on (b)(6) 2013 since the patient was complaining of a tingling sensation from the generator site when he swipes the magnet, does not occur with normal stimulation. System diagnostics resulted in output=ok/lead impedance=ok/dcdc=2/eri=no. The patient thinks the battery is dying because of the tingling sensation and was referred for a battery replacement. The patient's physician is 4 hours away and since the patient is in prison, has not been able to check the device. Good faith attempts for further information from the surgeon have been unsuccessful. Clinic notes were received dated (b)(6) 2013 which indicate that the patient's leads were functioning fine but he needs a new generator unit. The patient's settings were noted to be output=2ma/frequency=20hz/pulse width=250usec/on time=60sec/magnet output=2. 25ma/magnet on time=60sec/magnet pulse width=500usec.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed generator met specifications prior to distribution.

Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient was being in from prison for a surgical consult as the patient complained of pain from the device. Good faith attempts for further information from the physician were unsuccessful. On (b)(6) 2013 it was reported that the patient is still experiencing pain and the medical assistant was unsure of the nature or location of the pain. The surgeon stated that the prison did not explain whether the patient needed a battery or a battery and lead replacement surgery. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
On (b)(6) 2013 it was reported that the patient underwent prophylactic generator replacement surgery. The explanted generator was returned on (b)(6) 2013 for product analysis. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995994
« Last Edit: February 23, 2016, 02:50:51 AM by dennis100 » Logged
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« Reply #11 on: January 11, 2016, 03:54:39 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426771
« Last Edit: February 23, 2016, 02:51:08 AM by dennis100 » Logged
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« Reply #12 on: January 11, 2016, 07:03:32 AM »

Model Number 103
Event Date 09/27/2011
Event Type Injury
Event Description
Attempts for additional information and product return have been unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent explant due to hypothesia in the left neck and jaw, not related to stimulation. The patient demanded explant due to lack of efficacy and hypothesia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986739
« Last Edit: February 23, 2016, 02:51:24 AM by dennis100 » Logged
dennis100
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« Reply #13 on: January 14, 2016, 12:54:36 PM »

Model Number 102
Event Date 11/02/2012
Event Type Injury
Manufacturer Narrative

Event Description
Product analysis on the generator was completed on (b)(6) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications, and during the product analysis there were no anomalies found with the pulse generator. Pa on the lead was completed on (b)(6) 2013. Note that since the lead's electrode and anchor tether helix were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. However no obvious point of entrance was noted other than the identified tubing openings related to the explant procedure. No discontinuities were identified during the analysis. Other than typical wear and explant related observation, no anomalies were identified in the returned lead portion. A review of available programming history revealed no anomalies. The last available interrogation date was (b)(6) 2011. At that time the generator was enabled and diagnostics were within normal limits. Follow up performed with the treating surgeon was performed however he was unable to provide additional information as he indicated that the patient was evaluated by a neurologist and he was just asked to remove the device. Follow up performed with the last known treating neurologist was performed and it was indicated that they had not seen the patient since (b)(6) 2011. The pain and numbness had not been reported to his office; however he did indicate that the patient had been experiencing hoarseness since (b)(6) 2011. The neurologist did indicate that the patient had fallen off his bike in (b)(6) 2011, but he was unsure if this had contributed to the event. No other information was provided, and attempts to determine a more recent physician have been unsuccessful to date.

Event Description
It was reported that the patient was scheduled to have his vns removed. Clinic notes dated (b)(6) 2012, indicated that the patient was experiencing pain on the left side of his chest and numbness at his incision site. Additionally it was indicated that the patient was never doing "well" until the generator was turned off. Since that time he has not had any more seizures. The patient was referred for generator explant due to the pain. Attempts for additional information are in progress.

Event Description
It was reported on (b)(6) 2012 that the patient had his generator and lead explanted on (b)(6) 2012. The patient was not re-implanted. The explanted products were returned to the manufacturer on (b)(4) 2012 and product analysis is currently in progress and has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862854
« Last Edit: February 23, 2016, 02:51:39 AM by dennis100 » Logged
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« Reply #14 on: January 15, 2016, 10:55:01 AM »

Model Number 102R
Event Date 07/17/2012
Event Type Injury
Event Description
The patient's explanted products have not been returned for analysis after good faith attempts have been made.

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854766
« Last Edit: February 23, 2016, 02:51:56 AM by dennis100 » Logged
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« Reply #15 on: January 17, 2016, 05:48:17 AM »

Model Number 303-30
Event Date 11/01/2012
Event Type Injury
Event Description
Additional information was received when the two 3. 0mm leads that the surgeon had tried to implant in the patient were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative
Brand name; corrected data: inadvertently listed "lead model unknown" instead of "lead model 303" on initial report.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was scheduled for an ent evaluation. It was reported that the patient has left vocal cord weakness. Clinic notes dated (b)(6) 2013 were received which indicate that the patient has multiple medical problems including chf, dm, htn, copd, and cva ((b)(6) 2012) who presents to the neurosurgery clinic to be assessed for placement of a vagal nerve stimulator. The patient reported that over the past year, his seizures have progressed in frequency and severity with him now having multiple daily grand mal seizures; when his seizures first occurred, he notes he had one seizure per year. In (b)(6), the patient reports that the surgeon attempted to place a vns on two separate occasions but failed. The patient reports that his vagus nerve was too large which lead to the vns leads breaking each time. The patient has had dense hoarseness since the procedures. Due to the cross reactions between his aeds and cardiac medications, as well as the progressive nature of his seizures, the patient has been urged by his neurologist and cardiologist to have a vns placement attempted once more. Additional clinic notes were received from a visit with another surgeon who indicated that the patient has history of an mri showing evidence of a stroke involving a right artery. The patient is having progressively worsening frequency and severity of seizures refractory to current medications and has 2 failed vns placement attempts. It was stated that an assessment of the patient's vocal cords with an ent is needed as the nerve may be transected or permanently damaged. The patient was seen by an ent specialist on (b)(6) 2013 for evaluation of hoarseness and dysphagia. The patient's quality of voice was raspy and rough and the severity was moderate with a significant impact on voice quality or function. The hoarseness started 11/1/2012 after vns surgery. Associated manifestations are dysphagia, frequent heartburn, sore throat, and tobacco use. The patient feels like foods and liquids don't go down and get stuck, also chokes and coughs at times - all new since surgery. The dysphagia is in the lower throat and the patient feels like food sticks in the throat, has a "lump in throat sensation" and states that even swallowing air can give him a choking sensation. The event is moderately severe. Aggravating factors include swallowing liquids, swallowing saliva only, and swallowing solid food. Associated manifestations include frequent heartburn or indigestion, frequent or chronic hoarseness, frequent or chronic sore throat, neurological problems, and pressure sensation in throat. It was found that there was mobility reduced motion in left cord. The right vocal cord had normal mobility but the left vocal cord was limited. There was good approximation of vocal cord phonation but paresis of left vocal cord was suspected. The patient was referred for a barium swallow to evaluate swallowing issues. The operative notes from the (b)(6) 2012 surgery stated that the vagus nerve was exceptionally large comparative to average anatomy. The 2 mm lead was coiled around the nerve and after coiling it was noticed that the vagus nerve due to the extensive size was being strangulated by the lead placement. Due to the large diameter of the vagus nerve it was felt that the coil could not be kept in contact with the nerve without jeopardizing safety. At that point the procedure was aborted with the incision was copiously irrigated with antibiotic solution. The patient was noted to be morbidly obese. On (b)(6) 2013 it reported that the patient has been going to speech therapy and his voice is improving. The patient started speech therapy about 2 weeks prior and is seen 2 times per week for 2 hours. The patient underwent a modified barium swallow on (b)(6) 2013 and the notes from this visit indicate that the diagnosis was dysphagia and that the patient had left vocal cord weakness. The patient was noted to have a history of coronary heart disease, cva, diabetes, chronic back pain, obesity, and hypertension. The patient had resilient (l) side weakness from cva, gerd. The patient had decreased voice and reports coughing on liquids. Gerd was not observed during evaluation. The patient had aspiration throughout assessment. Oral and pharyneal phases of swallowing are normal. No aspiration with modified barium swallow under fluoroscopy.

Event Description
On (b)(6) 2012 it was reported that the patient was to have an initial implant that day, but the hospital only had 2 mm leads in stock and upon opening up the patient, it was found that he has a big vagus nerve. The surgeon attempted to implant the 2 mm lead but it was constricting the patient's nerve so it was removed and the patient was closed up. The patient was asked to stayed overnight at the hospital to have surgery the next day with a 3 mm lead that was being shipped to the hospital. The patient's wife did not want the patient to stay overnight and wasn't sure she wanted to risk him going through another surgery if the new lead does not fit. On (b)(6) 2012, it was reported that the patient underwent surgery again with a 3 mm lead. The surgeon noted that the vagus nerve was swollen from the previous surgery and due to the patient having a very large neck he was not able to get good enough exposure of the nerve to get the electrodes around the nerve. The patient was closed up again and sent home. The surgeon also noted that the two 3 mm leads he tried to use lost their coil form after trying to coil nerve.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when product analysis was completed on the returned leads. The condition of the returned leads was consistent with conditions that typically exist following manipulation of the leads. The patient stated that his voice is still raspy; he has to yell to be heard. The patient also mentioned that if he has a coughing fit, or laughs in a certain position, he feels like he is being chocked. The surgeon stated that he thinks the patient is too large and the leads will not fit. Although implant surgery is likely, it has not occurred to date.

Event Description
Additional information was received on (b)(6) 2013, when it was reported that a second surgeon told the patient he needed to see an ent (ear, nose, and throat) physician because the nerve might have been severed in the previous surgical attempt. The patient later reported that the second surgeon wants a veeg, ent evaluation, and or notes from the initial surgeon. The patient stated that he is still raspy, struggles to push out air and to be heard, when he touches the skin on the left side of neck to throat area, it feels numb. He also stated that if he laughs real hard or gets excited, he starts choking and may gag while drinking fluid, even on air. The patient stated that he has a history of choking on meat, but he thinks that is because he has no teeth.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744
« Last Edit: February 23, 2016, 02:52:13 AM by dennis100 » Logged
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« Reply #16 on: January 28, 2016, 12:55:39 AM »

Model Number 302-20
Event Date 01/01/2012
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2012, it was reported that this vns patient was experiencing severe neck pain, facial numbness, and "something about her wires" per the patient's primary care physician. The patient did not currently have a neurologist. The patient had been referred to a surgeon. Attempts for additional information have been unsuccessful. A battery life calculation on (b)(6) 2012, showed negative results to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2710521
« Last Edit: February 23, 2016, 02:52:31 AM by dennis100 » Logged
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« Reply #17 on: January 29, 2016, 01:47:46 PM »

Model Number 103
Event Date 06/22/2012
Event Type Injury
Event Description
It was reported that the patient's generator had migrated, and she was being referred for surgery. The patient was implanted with vns on (b)(6) 2012. Clinic notes dated (b)(6) 2012 indicated that generator had moved under the axillary region causing pain, pressure in the arm, and discomfort. The pain was indicated to be with movement. It was written that the patient would be referred to the surgeon to evaluate vns placement and make changes as needed. Additional information was received from the neurosurgeon after surgery consult revealing that the patient is experiencing numbness to the left arm due to the generator; moving around; the patient had generator replacement surgery on (b)(6) 2012 due to the generator migration. Attempts for product return have been unsuccessful to date. Attempts for additional information from the treating neurologist and implanting physician have been unsuccessful thus far. Additional information was however received on (b)(6) 2012 from the surgeon that performed the generator replacement which revealed that the migration caused the left arm pain and numbness. It was not believed the numbness was related to stimulation. It was not noted in the operative notes if the explanted generator appeared sutured down during generator replacement. However, it was confirmed that the replacement generator was secured to the pectoral muscle. The migration became symptomatic and quite painful before surgery for the patient which is why the patient had surgery. There was no indication of patient manipulation or trauma. No additional information was provided.

Event Description
It was reported that the explanted generator will not be returned for analysis, as the explanting facility requires patient signed release and they will not ask the patient at time of surgery, so therefore, this site will not return to manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662284
« Last Edit: February 23, 2016, 02:52:47 AM by dennis100 » Logged
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« Reply #18 on: February 01, 2016, 01:45:30 AM »

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

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

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

Manufacturer Narrative
Review of programming/device diagnostic history performed.

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

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

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2597650
« Last Edit: February 23, 2016, 02:53:05 AM by dennis100 » Logged
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« Reply #19 on: February 01, 2016, 09:45:27 AM »

Model Number 103
Event Date 01/27/2012
Event Type Injury
Event Description
On (b)(4) 2012, a copy of the physician's flashcard was received. The patient's programming history was reviewed. The programming history provided spanned (b)(6), 2012.

Manufacturer Narrative
Analysis of programming history. Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr reported incorrect settings for (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012. Additional information was received providing correct settings for these dates. This report is being submitted to correct this information.

Event Description
Clinic notes were received on (b)(6) 2012 from, a physician's office. The notes covered the patient's physician visit from (b)(6) 2011 to (b)(6) 2012. The patient was implanted on (b)(6) 2011, at which time the device was not programmed on. On (b)(6) 2011, notes reported pain at the surgical site, hoarse voice, and "multiple grand mal seizures after vns. " the vns incision lines looked good, were both healing well, without tenderness. The neck incision had surrounding swelling. On (b)(6) 2012, notes state that the patient's hoarse voice was gone, there was no more pain at the vns site, and no change in frequency. The notes indicate that the patient's device was turned on, and the patient did not feel anything. No settings are provided for this date, and initial interrogation at the next appointment indicates normal mode and magnet output currents were 0 ma. On (b)(6) 2012, the patient reported an increase in seizures and duration, along with aggression. The notes report that the magnet did seem to stop the seizures and make them shorter; however, settings from this date indicate that the device was programmed off until this appointment. The patient experienced painful magnet mode stimulation for the first magnet activation. On (b)(6) 2012, it was stated that the patient felt he had an upper respiratory infection the previous week. The patient turned during sleep and "felt spinal cord electricity," a lack of consciousness for 30 minutes, and then numbness throughout his head, which continued. There was now a change in seizures: the patient had a warning and then an out of body experience. He was unable to use the magnet during this time. The patient's aggression was reported to be less, he did not have any more headaches, but he did have neck pain. On (b)(6) 2012, notes reported that the seizures did decreased but have recently reoccurred. The patient occasionally coughed with vns but had no serious ill effects. The patient did experience coughing and choking during magnet stimulation; however, the magnet did abort seizures well. The patient's vns was adjusted, and the physician ensured that the patient tolerated both normal mode and magnet stimulation. On (b)(6) 2012, the patient was seen for increased blood pressure and a check of the patient's vns after the patient held a shocking dog collar while the collar was charging. The patient's vns settings were altered. This event is captured in mfr. Report # 1644487-2012-01066. On (b)(6) 2012, notes report that the patient was having the same amount of seizures (4/day) and no issues since turning the stimulator back on from the collar incident. On this date, the patient's settings were adjusted. On (b)(6) 2012, the patient was seen again for marked aggression, agitation, and an increase in grand mal seizures since the adjusted settings the previous day. The magnet did not seem to stop the seizures. The patient's mother taped the magnet over the patient's vns to disable the device, and all symptoms stopped. The patient's settings were reduced to (b)(6) 2012 settings. On (b)(6) 2012, the patient was reported to have a bad mood, irritable, snapping, and having more seizures. He was saying things he wouldn't have in the past and demonstrating almost manic-depressive type behavior. The patient became violent, hit his parents, screamed, held his head, demonstrated symptoms like a grand mal seizure, and later bit his finger. The patient was not able to perceive normal mode or magnet stimulation. The patient's mother felt that things were going well with vns at first, but felt as though the seizures were never really controlled. The patient's normal mode output current was programmed off, and the magnet was programmed to a higher output current that resulted in a cough lasting less than 5 seconds. Follow up with the nurse practitioner revealed the following information: the patient's increase in seizures was below his pre-vns baseline. The patient was treated by his primary care physician for the upper respiratory infection; however, the nurse practitioner did not think that the infection was related to vns. When asked about the change in seizure reported on (b)(6) 2012, no additional information regarding the change in seizures was available; however, the change was attributed to anxiety. The patient's anxiety was caused by vns: the presence of the device and the surgery. The nurse practitioner believes that the vns causes the patient anxiety. The anxiety, in turn, propagates more seizures. The patient was placed on medication to assist with the anxiety and sleep. There are discrepancies between the settings from appointment-to-appointment that may be due to recording errors. Attempts to obtain the physician's flashcard to review the patient's complete programming history are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584000
« Last Edit: February 23, 2016, 02:53:26 AM by dennis100 » Logged
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« Reply #20 on: February 01, 2016, 09:46:15 AM »

Event Date 04/10/2012
Event Type Injury
Manufacturer Narrative

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2585568
« Last Edit: February 23, 2016, 02:53:45 AM by dennis100 » Logged
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« Reply #21 on: February 02, 2016, 12:45:35 PM »

Model Number 302-20
Event Date 08/01/2011
Event Type Malfunction
Event Description
On (b)(6) 2012, this vns patient reported that she wanted her generator explanted. She stated that the device had been causing her problems for almost a year. She stated that it is not sitting in the pocket like it should be, and when she lies down, it "floats up" causing discomfort. She stated that she had a mini stroke a few months ago and around the same time, her device was turned off because it was shocking her. She stated that about 4-5 months ago, she was to have her explant scheduled, but it just had not happened. She had spoken with the surgeon in regards to her discomfort and was told that she doesn't have enough tissue in the area where she is implanted which may be the cause for the discomfort. She stated she had not experienced any manipulation or trauma that may have caused either the migration or the shocking sensation. Surgery is still likely, but has not occurred.

Event Description
On (b)(6) 2012, this vns patient reported that her physician stated that something was wrong with the wiring at the patient's (b)(6) 2012 appointment. The patient did not have specifics about the issue with the wiring but reports that the physician did run tests on the device. The tests and results are unknown. The patient reported that she was experiencing generator protrusion, generator migration, lead body protrusion, numbness on the left side of her body, pain at the chest/generator site, and painful stimulation. The patient said she never had any issues prior to this. The patient also reported that she does sometimes fall but cannot associate any specific incident prior to the start of the adverse events. It was reported that an order had been sent in for x-rays; however, attempts for any additional information have been unsuccessful to date.

Manufacturer Narrative
Adverse event or product problem, outcomes: corrected data: previously submitted mdr stated that the reported event was a malfunction. Additional information was received indicating that a serious injury requiring intervention occurred. This report is being submitted to correct this information.

Manufacturer Narrative
Date of event, corrected data: previously submitted mdr stated that the events began on (b)(6) 2012. Additional information was received that the problems have been occurring for almost a year. This report is being submitted to correct this information.

Event Description
On (b)(6) 2012, this vns patient reported increased seizures, generator migration, partial paralysis, shocking generator, and jumping in the neck. The patient's physician believed that the temporary paralysis was due to the consecutive seizures, not vns. On (b)(6) 2012, the patient's family member reported that the patient was last seen by her physician three weeks prior to (b)(6) 2012. The family member stated that the patient needed the device disabled due to migration and pain and requested assistance finding a closer physician. On (b)(6) 2012, it was reported that the patient had a mini-stroke and needed an mri. Attempts for additional information are underway.

Event Description
On (b)(6) 2012, a fax was received from the physician's office. The fax indicated that the painful stimulation at the generator site and the partial paralysis were related to vns. The patient's device was disabled as an intervention, and explant is planned. The patient denied any trauma. No programming history was available as the patient was implanted at another site. The patient did not have a medical history of paralysis; however, it was noted that the patient had a cva prior to vns. The patient had not been evaluated by an ent. The patient wished for the device to be explanted due to pain and paralysis. The device was reportedly not working due to the patient experiencing pain. The patient's mother reported that device was inconsistently on and off. Surgery is still likely, but has not taken place.

Event Description
On (b)(6) 2012, this vns patient called complaining of a shocking sensation and generator movement. Attempts for additional information have been unsuccessful to date.

Event Description
On (b)(6) 2012, the physician's office reported that the patient wanted her vns explanted. On (b)(6) 2012, follow up with the physician's office revealed that the patient wanted the device explanted because she was being evaluated for a stroke, and the device was not working properly. The office could not clarify what was meant by "the device was not working properly. " the patient just wanted the device out, and the physician was agreeable to that. The patient was first evaluated in the office on (b)(6) 2012. The paralysis was on the left side of the patient's body. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

Manufacturer Narrative

Event Description
On (b)(6) 2013, the patient was seen for consult for surgical removal of the device. The patient apparently some issues regarding pain and migration of the generator around the left breast area. The wound appears to be well healed in the cervical and pectoral area, and no infection appears to be present. Nonetheless, the implant is not helping her. The device was currently disabled. Surgery is likely but has not taken place. Review of additional programming history showed that the pt's's device was disabled on (b)(6) 2012. A system diagnostic from (b)(6) 2012 indicated normal results.

Manufacturer Narrative
Review of additional programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2554727
« Last Edit: February 23, 2016, 02:54:03 AM by dennis100 » Logged
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« Reply #22 on: February 03, 2016, 10:22:56 AM »

Model Number 102
Event Date 01/01/2012
Event Type Injury
Manufacturer Narrative
Analysis of programming history performed.

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

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

Event Description
Additional information was received on (b)(6) 2012, when analysis of the explanted generator was completed. During the analysis, it was observed that the septum was not cored thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2535518
« Last Edit: February 23, 2016, 02:54:24 AM by dennis100 » Logged
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« Reply #23 on: February 12, 2016, 09:12:00 AM »

Model Number 302-20
Event Date 02/01/2012
Event Type Malfunction
Event Description
It was reported to the manufacturer that the patient had high impedance on a system diagnostics test performed on (b)(6) 2012. It was indicated that the last acceptable diagnostics for this patient were performed in (b)(6), however no specific results were provided. The physician indicated that there was no trauma or manipulation to the device. The patient's device was disabled, and it was indicated that the patient would be sent for x-rays which would be provided to the manufacturer for review. The x-rays have not yet been received. The physician also noted that the patient had been experiencing headaches with stimulation and also painful stimulation at neck region for about (b)(6) prior to this report of high impedance. The patient was referred for and underwent a full revision on (b)(6) 2012. The explanted products will not be returned as the hospital's policy requires the hospital to keep explanted products for 7 years. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received from the physician on (b)(6) 2012. An x-ray assessment performed by the site was provided and indicated that no fractures were observed. This however cannot be confirmed as the x-rays have not been sent to the manufacturer. It was indicated that the patient was complaining of headaches, stomach pains, tingling in her neck and chest with vibrating in her voice. She was also complaining of being shocked with headaches. The patient's settings were provided. No additional information was provided.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2482832
« Last Edit: February 23, 2016, 02:54:42 AM by dennis100 » Logged
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« Reply #24 on: February 16, 2016, 03:31:16 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438386
« Last Edit: February 23, 2016, 02:55:02 AM by dennis100 » Logged
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« Reply #25 on: February 17, 2016, 01:43:41 AM »

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

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2435388
« Last Edit: February 23, 2016, 02:55:19 AM by dennis100 » Logged
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« Reply #26 on: February 18, 2016, 04:40:01 AM »

Model
« Last Edit: October 16, 2018, 01:23:59 PM by dennis100 » Logged
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« Reply #27 on: February 19, 2016, 04:53:08 AM »

Model Number 102
Event Date 11/21/2006
Event Type Malfunction
Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.

Event Description
The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.

Event Description
On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.

Event Description
Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.

Event Description
Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008
« Last Edit: February 23, 2016, 02:55:57 AM by dennis100 » Logged
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« Reply #28 on: February 22, 2016, 04:02:35 AM »

Model Number 302-20
Event Date 12/01/2008
Event Type Malfunction
Manufacturer Narrative

Event Description
Further information from the physician indicates that the tingling in the chest is not believed to be due to vns, but the exact cause is unknown and it is "hard to discern" if it was occurring with stimulation. Per physician, the patient's symptoms do not appear to be consistent. The patient does not have a history of the tingling pre-vns. Per physician, causal or contributory programming or medication changes preceded the onset of the events, but no specifics were given. No patient manipulation or trauma occurred that is believed to have caused or contributed to the events. It is unknown whether a nonabsorbable suture was used to secure the generator. The physicians do not feel the issue is with the vns and recommended the patient get a second opinion.

Event Description
Additional information was received that the patient had full revision surgery. The patient's mother felt their was an issue with their device regardless of diagnostic testing being within normal limits therefore a complete revision was performed. The explanting hospital indicated that their explanted products would be returned for analysis.

Event Description
Additional information was received that no diagnostics were run prior to surgery. The device was checked to make sure it was still off but no diagnostics were performed. It had been off since (b)(6) 2008. No diagnostics were performed in the or prior to explant. The generator had migrated and it was hard for the surgeon to find it. The patient was large and he had to do a lot of searching and get a portable x-ray machine to come into room in order to locate the generator. The surgeon did not report seeing a lead break in the or nor anything unusual with the lead. The patient is doing well now since replacement. Nothing was noted or reported in regards to anything seen that would have attributed to their reported pain. Product analysis was completed on the patient's explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on their explanted lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The silicone tubing of the lead has what appears to be a tear opening at approximately 0. 3cm from the end of the connector boot. The positive coil is protruding out from the silicone tubing at this location forming a loop. A broken strand was identified in the positive coil at this location. The inner silicone tubing of the lead coils is covered with what appears to be organic matter at the loop located at the 16-17. 2 cm from the boot. The organic matter was removed to perform proper inspection of the lead coils. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. Visual analysis of the broken strand of the positive quadfilar coil shows that a stress-induced fracture has occurred. Note that since the electrode array portion was not returned for analysis an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative
Device failure caused event but did not cause or contribute to a death. Suspect medical device brand name; corrected data: updated to lead. Corrected data: model/serial number/lot number/expiration date updated to lead. Type of reportable event corrected data ; updated to malfunction. Device manufacture date; corrected data to lead information.

Event Description
It was reported that the patient developed a tingling in her chest in (b)(6) 2008 and the device was turned off. The patient had no pain then. In (b)(6) 2011, the device was turned back on device, but 48 hours later, it was turned off again due to pain. The device has now migrated up and is flipped over according to physician after viewing the x-rays. It was decided to turn the device on to low settings and schedule a follow up visit. The physician is also getting a social worker involved as the patient's behavior seems to be different and change with the presence of the mother in the exam room. According to physician, after reviewing the x-rays, there is no obvious break in the lead and after running a system diagnostics and normal mode, both tests appear to be within normal range. X-rays were sent to manufacturer for review, and no anomalies were noted. The patient was seen for follow-up and wanted the device turned off due to pain. Per reporter, there is a disconnect of where the pain is between the mother and daughter and concern that there may be something else going on with the mother and daughter as the stories don't quite match per physician. Attempts for further information have been unsuccessful to date.

Event Description
The lead only had one broken strand. The broken strand would still allow for current flow through the remaining three filars/strands of the quadfilar coil lead therefore the patient could receive some therapy. It is undetermined how much therapy they would have received.

Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2385673
« Last Edit: February 23, 2016, 02:56:14 AM by dennis100 » Logged
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« Reply #29 on: February 23, 2016, 02:56:51 AM »

Event Date 11/22/2011
Event Type Malfunction
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

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

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

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

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

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

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