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dennis100
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« Reply #30 on: July 11, 2018, 07:59:10 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/26/2018
Event Type  Injury   
Event Description
Report received that a pain had pain that radiated from her generator site to her neck, face, and right side of her head. This pain was reportedly worse upon exertion but also occurred while sitting. The pain had reportedly occurred for three weeks with a few severe episodes. The patient also reported feeling fatigued. The patient reportedly went to the hospital during one severe painful experience where cardiac work was done. Although the results were negative, there was reportedly some bradycardia. The physician reported that the vns was checked and the settings were "low". The impedance was also reportedly checked and was found to be within normal limits. The physician elected to disable the device but indicated he would refer the patient for follow-up with a surgeon for reevaluation of other etiologies. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997
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dennis100
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« Reply #31 on: July 11, 2018, 07:59:53 AM »

Model Number 106
Event Date 07/04/2016
Event Type  Injury  
Manufacturer Narrative

Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that vns patient got admitted to the hospital due to jaw pain and would not walk anymore following a generator replacement surgery due to battery depletion. It was reported that the newly implanted generator was programmed to therapeutic settings on the date of implant. Additional information was received that it's unclear if the pain is related to stimulation but the patient has serious behavior issues, so this might be linked to behavior. Nurse also reported that the events could be linked to the change of medication. It was reported that device diagnostics results were within normal limits.

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dennis100
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« Reply #32 on: July 12, 2018, 01:19:07 AM »

Model Number 302-20
Event Date 04/18/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Further information was received communicating that the patient had complained of severe pain around the stimulator aggregate and its proximal cable part due to tissue induration. The physical examination revealed hard scar tissue in the area of the stimulator and its proximal cable. The stimulator testing in the clinic revealed no malfunction. The patient underwent a surgical revision and during revision it was found that the stimulator and the proximal part of the lead were surrounded by very hard scar tissue. Fluid leaks were found as well in the lead and a full system revision was conducted. Both, the lead and the generator were explanted and replaced with new devices. No x-rays were taken prior or after surgery and no trauma or manipulation was reported. The explanted products were not returned to the manufacturer for analysis.
 
Event Description
It was reported through an implant card that a vns patient was re-implanted with vns therapy. The reported explanted devices were explanted due to lead discontinuity and due to loss of function in accordance to the implant card. At the moment good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2346309
« Last Edit: September 13, 2018, 02:08:43 AM by dennis100 » Logged
dennis100
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« Reply #33 on: July 12, 2018, 01:19:51 AM »

Device Problem No Known Device Problem
Event Type  Injury   
Event Description
This patient reported that they had their vns for four years and it was giving them problems. Therefore they had it removed, and are now in the worst pain they have ever felt. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7475196
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dennis100
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« Reply #34 on: July 12, 2018, 01:20:47 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient received a generator replacement and the generator was disposed of after surgery. There was no repositioning of the new generator and a new pocket was not created. No other relevant information has been received to date. No known surgical intervention for the lead has occurred to date.
 
Event Description
The patient's neurologist provided clinic notes for surgery referral indicating that the patient has some gagging with vns swipe, as well as increased prominence of lead in left side of neck, with some tenderness to palpation. The patient still feels vns stimulation. The lead was very superficial with a sharp edge protruding through but not piercing the skin. The patient has neck pain and it is a concern that there is migration of the lead laterally, as well as migration of the vns in the chest. It was questioned if the patient has encountered a loss of efficacy both with normal output current stimulation and the magnet swipe as the patient had experienced an increase in seizures. The neurologist followed up with an ent surgeon for an evaluation to assess the leads. Additional information was received from the neurologist stating that the cause of the lead protrusion, migration, dysphagia, increased seizures, loss of efficacy, and pain in the left neck was unknown. The patient was experiencing an increase in seizures that was below pre-vns levels. There were no factors such as trauma or manipulation that could have contributed to the events, and lead and generator migration as well as loss of efficacy were the contributing factors for the patient¿s surgery referral. The patient's gagging, protrusion and tenderness in the left neck were not contributing factors for the patient's surgery referral. The generator¿s most recent battery status was stated to not be at end of life. No other relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7490466
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dennis100
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« Reply #35 on: July 12, 2018, 01:21:54 AM »

Model Number 102
Event Date 10/04/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.
 
Event Description
Initially, it was reported that the patient has been experiencing difficulty swallowing and shortness of breath. The patient reported that this is more often than not. The patient also reported that it feels like the device is shocking her from the generator to up under her tongue. The patient reported that taping the magnet over the generator was attempting, but was too painful. The patient also reported that the generator feels like it is slipping down into her armpit. The patient reported that the device has not been checked in three to four years. The patient was later seen by a surgeon and surgery was scheduled. It is unknown whether or not surgery occurred as planned. Attempt to obtain additional information have been unsuccessful to date.
 
Event Description
Further follow-up revealed that the patient's surgery occurred as planned on (b)(6) 2013. Only the generator was explanted. It was reported that the surgery was for patient comfort. It was reported that the patient was not using vns therapy as prescribed because the patient wasn't being followed by a psychiatrist and having the device programmed as needed. No known causal or contributory factors preceded the onset of the events. It is unknown if a non-absorbable suture was used to secure the generator to the fascia during the implant surgery. Attempts to have the generator returned for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3472747
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« Reply #36 on: July 12, 2018, 01:22:43 AM »

Model Number 105
Event Date 05/10/2012
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative

Event Description
Initially, it was reported that the patient was scheduled for explant due to unknown reasons. It was later reported that the patient experiences multiple side effects which were worsened after generator replacement in 2012. It was noted that the patient experienced dysphonia with device activation and dysphagia to pills. The patient also noted atrial fibrillation with seizures, submandibular tenderness, gastroparesis, left-sided breast pain and left-sided jaw pain. It was noted that the symptoms continued after programming the device off. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient underwent vns explant. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5526231
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dennis100
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« Reply #37 on: July 12, 2018, 01:23:45 AM »

Model Number 102
Event Date 11/21/2006
Event Type  Malfunction   
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.
 
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 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
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
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008
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dennis100
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« Reply #38 on: July 12, 2018, 01:25:06 AM »

Model Number 302-20
Event Date 09/17/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Lead analysis was approved on (b)(4) 2014. Analysis showed that the reported lead fracture allegation was confirmed. Note that the green electrode including a portion of the white electrode inner silicone tubing and quadfilar coil were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis the (-) connector pin quadfilar coil appeared to be discolored and dissolved, in some areas. Scanning electron microscopy (sem) was performed and identified areas as being thin, having extensive pitting which prevented identification of the coil fracture type and evidence of electro-etching on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. During visual analysis, an abraded opening was observed on the (-) connector pin inner silicone tubing. Abraded openings were observed on the outer silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Operator of device, corrected data: previously submitted mdr indicated that the medical professional was the user; however, this should be the patient. (b)(6). This report is being submitted to correct the aforementioned fields.
 
Event Description
Clinic notes dated (b)(6) 2013 were received which indicate that the vns provided benefit initially after implant, but the patient has recently been experiencing serious complications with recurrent seizures and significant neck pain in the region of the stimulator wire. Because of this, it was reguested that the patient have an urgent evaluation of the vns device. Diagnostics were not provided; however, it was stated that the device might be nearing end of service. A battery life calculation estimates a minimum of 0. 89 years until end of service. Good faith attempts were made for additional information; however, they were unsuccessful. No additional information was received.
 
Manufacturer Narrative
Adverse event or product problem, corrected data: the initial mdr only listed serious injury; however, product problem should have been selected as well. Type of reportable event, corrected data: malfunction should have been selected on the initial mdr.
 
Event Description
On (b)(6) 2013, it was reported that this patient was undergoing generator revision. The generator could not be interrogated at the time of surgery, so it was replaced. After attaching a new generator the existing lead, high impedance was observed. A lead revision was initiated. When the neck incision site was opened, the surgeon found a great deal of scar tissue and a severed lead wire. The vns system was fully removed (without re-implant) at the time due to insufficient vagus nerve available. Attempts for product return have been unsuccessful.
 
Event Description
The generator and lead were returned for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3453122
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dennis100
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« Reply #39 on: July 12, 2018, 01:26:01 AM »

Event Date 01/01/2009
Event Type  No Answer Provided   
Event Description
Rptr began to have increased neck and shoulder pain and increased seizures. The dr said it was arthritis and sent her to a pain specialist. It could be seen migrating, the device had disconnected. Decreased the voltage. Rptr finally had it removed 6 mos after her initial complaint. She was placed on additional anticonvulsants keppra and vimpat. She was already on dilantin and gabapentin. Rptr has developed anorexia and is losing weight. She is now (b)(6). She also is having trouble walking and has developed tremors. She feels it is from the medication and expresses concern that it has taken her physician so long to take drug levels when she has been wanting them done. Now he wants to take a battery of lab tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2666397
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« Reply #40 on: July 13, 2018, 02:33:46 AM »

Model Number 10X
Event Date 12/29/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient had shown symptoms of autoimmune process which is appeared with subfebrile temperature, pains in joints etc, but the locus with generator is absolutely intact. The event began on (b)(6) 2012. The symptoms included high temperature, pain in the right knee and left elbow joints while moving, and swollen, hot joints. The patient was hospitalized with anti-inflammatory therapy. The antibiotics were applied successfully, and the patient left the clinic. The high temperature and pain began again on (b)(6) 2013. The locus of generator was intact. Anti-inflammatory therapy was continued. The number of seizures was increased almost to the pre-vns baseline (after vns implant, the patient experienced a 50% seizure elimination). Doctors did not determine the clear causes of the situation, but pediatricians tended to relate it to vns. The patient's heredity is free of distinctive features. The mix of antiepileptic drugs and vns parameters were not modified. The previous week, the patient left the clinic with satisfied status. The diagnosis was juvenile rheumatoid polyarthritis. The rheumatoid tests are negative. Cytostatics are not prescribed because the diagnosis is disputable. The generator was never disabled. No diagnostics are available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2976156
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dennis100
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« Reply #41 on: July 13, 2018, 02:34:22 AM »

Model Number 103
Device Problem Energy output to patient tissue incorrect
Event Date 01/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a patient that he experienced ear pain and increased headaches (b)(6) 2017-(b)(6) 2017, at which point the physician decreased settings and provided medication, but this did not help. On (b)(6) 2018, the patient went to the emergency room (er) due to headaches. The patient used the magnet and believed this turned off the device and when he saw his physician it was stated the magnet was off. The patient then stated he experiences erratic stimulation since he had seen the physician last. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7469911
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« Reply #42 on: July 13, 2018, 02:35:08 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 05/15/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing some complications from her vns device and was referred for evaluation by the surgeon. The patient had acute spasmatic pain in the left neck and coughing lasting seconds whenever her magnet was swiped. However, the patient also experienced this 6-8 times per day spontaneously. The physician stated that there was no abnormality with the lead and that he suspected potential glossopharyngeal neuralgia. The physician prescribed gabapentin for the left neck paroxysmal pain. No surgery has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7596790
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« Reply #43 on: July 13, 2018, 02:36:01 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing pain around the vns and going down her arm when lifting. The surgeon prescribed anti-inflammatory for a weeks and the pain did not resolve. The patient was referred for prophylactic vns replacement surgery. Follow up with the physician revealed that the patient reported no trauma to the area. No cause for the pain was found. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7577968
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« Reply #44 on: July 13, 2018, 02:36:49 AM »

Model Number 102
Event Date 05/17/2006
Event Type  Injury   
Event Description
A vns patient initially reported that he has constant hoarseness since implantation of his vns (not occurring with stimulation). He also stated that since (b)(6) 2008, he gets nauseated, has acid reflux and, has left thigh pain. Magnet use does not relieve any of these symptoms. Patient stated that his device was turned off in 2007 for almost a year but still experienced voice hoarseness. He chose to turn the device on in 2008 as his depression was increasing. On (b)(6) 2010, he reported to the manufacturer that his vsn device has been turned off since (b)(6) 2008 because his vocal cord was partially destroyed. Good faith attempts to obtain more information about patient's voice hoarseness and vocal cord status have been unsuccessful to date since psychiatrist needed an authorization for release of information from the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1966132
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« Reply #45 on: July 13, 2018, 02:37:51 AM »

Model Number 304-20
Event Type  Injury   
Event Description
A vns treating physician reported that a vns patient was complaining of left throat pain, described as "a little buzz in throat. " it was reported that this had been going on for a few months, but the physician did not think it was related to their vns, so didn't raise any concerns about it before. But now, it is ongoing, so he referred the patient to a gi specialist who diagnosed the patient with left vocal cord paralysis. There is no change in the patient's voice whatsoever. No changes were made to settings. The patient has had a remarkable response to vns therapy for her seizure disorder. Good faith attempts have been made and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3068216
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« Reply #46 on: July 13, 2018, 02:38:37 AM »

Model Number 102
Event Date 11/22/2010
Event Type  Injury   
Manufacturer Narrative
Report source: follow-up report #2 inadvertently did not indicated company representative as a report source.
 
Event Description
It was indicated through a periodic programming history database review that the patient's device was found to be disabled as of (b)(6) 2018. Upon follow-up with the patient's physicians, it was noted from the patient's first and only appointment at that office that the patient had reported concern of pain around the vns and that she wanted the device explanted. The device was disablement at this visit due to the reported pain. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient had a full revision in 2010 and since then has reported pain in both of her arms and chest/ rib cage area. The physician disabled the patient's vns device for a brief period; however, they could not determine the relationship to vns or if the pain was related to stimulation. It was also reported that the patient had an extreme allergic reaction to the anesthesia during the full revision, but the connection to vns and the reports of pain were unclear. The patient's last known settings were provided and it was noted that ifi = no. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Event Description
On (b)(6) 2013, the nurse from physician's office called back about the patient. She stated that the patient is still in pain. The patient was tested for infections, musculersclerosis, "everything", but everything turned out negative. It was reported that it was possible it could be pain syndrome, but the cause of the pain is unknown. On (b)(6) the patient's device was turned off; however, the patient was still experiencing pain. It was concluded that the pain was not associated with stimulation on times and the nurse stated that they could not see any relationship between the pain and vns. It was also reported that the patient had shortness of breath related to the vagus nerve. Physical therapy was suggested to the patient for thoracic syndrome and the nurse stated that they would be following up with that. The patient also has anxiety issues, which was a possible contributing factor, per the nurse. In regards to the allergy, the patient was given benadryl and referred to the primary care physician. There was no verification from physician's office that anything was done. The nurse clarified that the parent reported there was an allergic reaction, but there was no documentation to support that there ever was such a reaction. The only information the physician has on the allergy was the parent's report. The patient is experiencing pain in the knees, chest, and arms. There have been no medication changes or external factors (from a neurological standpoint) that would have caused or contributed to the event. No direct correlation has been found for the cause of the pain. The nurse stated that at this point everything is speculation. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3194207
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« Reply #47 on: July 25, 2018, 05:59:52 AM »

Model Number MODEL 250
Event Date 01/01/2010
Event Type  Malfunction   
Event Description
It was initially reported that the pt was experiencing random stimulations and jabbing pain. It was later determined that the pt's settings were at incorrect settings. It appears that there may have been interruption during the system diagnostics as the pt was now at 60 min off and the magnet output current was now at 1. 0ma instead of 0. 00ma. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1931693
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« Reply #48 on: August 07, 2018, 01:11:24 AM »

Model Number 102
Event Date 11/01/2010
Event Type  Injury   
Event Description
It was reported by a nurse that a vns patient was scheduled to see the surgeon for repositioning of her vns device as it was causing pain. At the moment good faith attempts to obtain additional information from the surgeon have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1913995
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« Reply #49 on: August 07, 2018, 01:11:54 AM »

Model Number 102
Event Date 06/24/2010
Event Type  Injury   
Event Description
Reporter indicated that a patient's vns generator was explanted due to pain and was not replaced. Manufacturer review of available vns programming history noted the vns was disabled in (b)(6) 2009. Attempts for further information and return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1924650
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« Reply #50 on: August 07, 2018, 01:12:27 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description
Additional info was received from the pt indicating she continued to have a hurting sensation in the neck area where the electrodes were. The pt indicated that the event had been occurring ever since vns implant and her implanting physician would not remove her electrodes. Further info from a company rep indicated the pt was scheduled to see a surgeon for explant consult. F/u was made with the surgeon's office and indicated the pt is scheduled to undergo vns generator removal surgery as the pt complains of pain at the generator site. The pt's device is off and pt wants it out. The surgeon's office indicated the surgery was to preclude a serious injury and had no additional info regarding the pt's treating neurologist. Additional info from the surgeon's office indicated the pt underwent generator removal surgery as scheduled. Good faith attempts to obtain the explanted generator have been unsuccessful to date.
 
Event Description
Additional information was received from the patient on 12/21/2017 that the vns would constantly hurt her in the chest and where the wires were in the neck. She stated it started shorting out years prior. After the battery died it was still hurting her until she had it removed. She stated there was too much scar tissue in the neck on the electrodes and could not be completely removed. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the physician provided that the vns had served the patient well but that the patient had other underlying issues and offered to remove her vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1959461
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« Reply #51 on: August 07, 2018, 01:14:03 AM »

Model Number 304-20
Event Date 12/05/2010
Event Type  Injury   
Event Description
Reporter indicated a vns pt was having constant pain at the vns electrode site in the neck that was not related to stimulation. No trauma or device manipulation occurred. Disabling the vns did not resolve the pain. The pt was hospitalized and placed on morphine pain medication. The vns generator was explanted and the vns lead was left intact in the pt. The pt has since had a new vns generator implanted. After explant of the vns generator, the pt's pain resolved. The explanted generator has been returned and is currently in product analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947680
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dennis100
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« Reply #52 on: August 08, 2018, 12:47:56 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
Information was received that the patient was experiencing pain at the generator site that reportedly felt random. It is not clear at this time if this is related to the current report of pain, or to an event the patient experienced several years ago that required admission for pain control (reported on mfr report # 1644487-2018-00680). It appears that revision surgery (reported on the initial report) was also taken due to the pain at the generator site. The device was discarded and will not be received for analysis. No additional or relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Clinical notes were received stating that the patient was experiencing pain in the neck and that the patient was referred for replacement due to the pain. The device was subsequently replaced. The explanted product has not been received for analysis to date. No additional or relevant information has been received to date.
 
Event Description
Information was received clarifying that the pain at the generator site, for which surgery was taken, was a current complaint and not related to an event from 2011 (which is reported on mfr report # 1644487-2018-00680). It was also clarified that the patient was experiencing a "grinding" feeling at the site of the generator, and that the surgery was taken to reposition the new generator. The patient was reported to be doing well since the surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7468315
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dennis100
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« Reply #53 on: August 09, 2018, 05:33:25 AM »

Model Number 102
Event Date 03/16/2010
Event Type  Injury   
Event Description
It was reported by a neurosurgeon that a vns pt had her device removed due to pain at her incision sites, i. E. , chest and neck region. The neurosurgeon attributed pt's pain to presence of the device since turning off the device did not resolve pt's pain. No medication changes occurred prior to pt's pain and neurosurgeon increased the therapeutic level of the generator on (b)(6) 2010, by 0. 25ma. Mfr received the explanted generator and lead and product analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979717
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dennis100
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« Reply #54 on: August 09, 2018, 05:34:03 AM »

Model Number 300-30
Event Date 12/01/2010
Event Type  Malfunction   
Event Description
It was reported by a nurse that a vns patient reported buzzing and pain in the top of his head that had occurred 3 times within the last 3 weeks of initial report. The patient reported that placing the magnet on the generator ameliorated the pain. Moreover, the patient indicated the pain was not occurring with normal stimulation and no patient manipulation or trauma was reported. The nurse further stated that a generator diagnostic tests was performed and received a low impedance warning. The patient was interrogated and the device was found to be at 0 ma. The patient was re-programmed to 1. 5/25/500/30/1. 1 then performed system diagnostics which resulted within normal limits (ok/ok/1/no). Further information from the treating nurse indicated that the patient was scheduled for complete replacement. Moreover information from a company representative indicated the patient underwent surgery as scheduled. Good faith attempts to obtain the explanted devices have been unsuccessful to date. Additional information was received from the treating neurologist indicating the cause of the buzzing was related to generator with/ or wire malfunction. Moreover, the replacement surgery was done for patient comfort according to the neurologist.
 
Manufacturer Narrative
Corrected data: new information received indicates that the lead was not explanted.
 
Event Description
Further follow-up revealed that during the surgery a dual pin generator was not available. It was reported that the patient was closed and a dual pin generator was located and the patient was taken back to the operating room the same day for only generator replacement. The lead was not replaced as previously reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1989992
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dennis100
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« Reply #55 on: August 10, 2018, 04:11:02 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that a patient was to have her device replaced due to pain at the site. Clinic notes were received indicating that patient has had severe left neck pain, dysphagia and hoarseness with stimulation. The device had been turned off and the patient had experienced an improvement of symptoms since having the device off. It was indicated the patient previously had a left thyroid lobectomy. It was noted from a recent office visit that the patient felt pain in her neck and throat that radiated into her jaw and left face. The patient had difficulty swallowing and had been eating less as a result. She stated she had been to the er at least once for the pain. The device output was lowered, and the patient still felt pain. Both output and magnet current were turned off. Diagnostics indicated no issues and battery life ok. The physician plans to have the battery replaced and possibly lead revised. From follow up with the neurologist, it was stated that the patient had not experienced any trauma to the site or other events that may have led to the adverse events. No surgery has occurred to date. No other additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709600
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dennis100
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« Reply #56 on: August 11, 2018, 01:17:30 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/07/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was initially reported that the patient was referred for vns generator replacement surgery due to an end of service, or eos, = yes batter status. However, an implant card was later received by the manufacturer indicating that the patient underwent replacement surgery due to pain and migration, which was reported in mfg. Report #1644487-2018-00837. The explanted generator was received by the manufacturer. Generator product analysis was completed. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the pulse 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 device performed according to functional specifications. Due to a disparity between the battery voltage (data in the diagvbat memory locations - 2. 787v) and battery consumption value (data in the diagaccumconsumed memory locations - 22. 488%) obtained from the ¿as-received¿ decoder download, the pulse generator was opened. With the pulse generator case removed and the battery still attached to the pcba, the battery measured 2. 987 volts, an ifi=no condition. The battery was removed. The printed circuit board assembly, or pcba, was subjected to electrical testing. Results showed that the pcba failed several electrical tests, including heartbeat verification and supply current during stimulation and off times. There were observed contaminates on the trimmed edge of the pcba. Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the pcba. After the trimmed edge of the pcba was cleaned, another electrical test was performed. Results were then within normal limits. Based on the electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of specification) for the standby modes of operation, and may have been the contributing factor for the premature battery depletion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7704803
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dennis100
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« Reply #57 on: August 11, 2018, 01:17:59 AM »

Model Number 304-UNK
Device Problems High impedance; Therapy Delivered to Incorrect Body Area
Event Date 06/20/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the er because she was having neck pain near her vns electrodes. Diagnostics were performed, and high impedance was detected. As a result, the generator was programmed off. The patient underwent replacement surgery the next day. The impedance resolved after the generator was replaced, so the lead was not replaced. Generator diagnostics and pin reinsertion weren't performed. After surgery the patient's new generator was programmed on and the patient was fine. A few days later, the patient was admitted due to pain in the neck and ear. Therefore, her device was programmed off. Diagnostics were within normal limits, and no impedance warning messages were observed. The patient was discharged but still experiencing pain in the neck and ear. The neurologist and neurosurgeon didn't think it was related because the device was off. No further relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7688213
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dennis100
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« Reply #58 on: August 11, 2018, 01:18:27 AM »

Model Number 304-UNK
Device Problems High impedance; Therapy Delivered to Incorrect Body Area
Event Date 06/20/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the er because she was having neck pain near her vns electrodes. Diagnostics were performed, and high impedance was detected. As a result, the generator was programmed off. The patient underwent replacement surgery the next day. The impedance resolved after the generator was replaced, so the lead was not replaced. Generator diagnostics and pin reinsertion weren't performed. After surgery the patient's new generator was programmed on and the patient was fine. A few days later, the patient was admitted due to pain in the neck and ear. Therefore, her device was programmed off. Diagnostics were within normal limits, and no impedance warning messages were observed. The patient was discharged but still experiencing pain in the neck and ear. The neurologist and neurosurgeon didn't think it was related because the device was off. No further relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7688213
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dennis100
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« Reply #59 on: August 11, 2018, 01:18:59 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had a consultation visit due to a "cuff complaint. " follow up with the physician's office resulted in the manufacturer receiving the consult notes for the patient. The notes indicated that the patient experienced discomfort at the left neck vns site. The patient had a prominent mass at the location and had experienced difficulty sleeping at night due to the discomfort and sensation of tightness in the neck. It was reported that there was mild bowstringing of the wire and prominence of an anchor at the neck. The patient underwent a superficial vns lead revision to remove the prominent hardware and relax the wire. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7707618

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