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dennis100
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« on: August 02, 2018, 08:37:24 AM »

Model Number 302-20
Event Date 06/01/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2012, it was reported that there were complications during this vns patient's surgery on (b)(6) 2012, and high impedance was seen. Follow up with the physician on (b)(4) 2012 revealed that high impedance was seen on (b)(6) 2012 and diagnostics showed that the device was at end of service; however, the high impedance was not acknowledged. Pre-operative diagnostics were not run as the surgery was scheduled to be a battery replacement. Operative notes were also received on (b)(4) 2012. The notes indicated that in the surgery, the old generator was removed and a new generator was replaced and secured. Multiple attempts with integrity testing with the eef lab technician were unsuccessful, deeming a lead failure. The notes reported that dissection down through the subcutaneous tissue encountered quite a bit of scarring and inflammatory response, but there were no signs of infection. The internal carotid artery was identified, as was the jugular vein which was large for his size. The vagus nerve was identified with the vns device on the vagus nerve, and it was quite enlarged, consistent with some inflammatory response around the device and the nerve. While trying to dissect up above the device, there was a small tear created in the jugular vein and immediately quite a bit of blood was noted to be coming from the wound. Due to the blood loss and the ongoing inflammatory response in the neck, it was decided that the patient's surgery would be postponed until another day. The device was amputated in the chest, and with careful inspection, there was a question of whether there was a crack about four centimeters from the insert of the generator. The tear in the jugular vein was due to the adhesion to vagal nerve stimulator lead. The device was reportedly returned to the manufacturer for review; however, it has not been received. The notes stated that the plan would be to obtain authorization to have the entire device, lead and generator, replaced. On (b)(4) 2012, confirmation was received that this patient had undergone generator and lead implant surgery on this date. Attempts for product return have been unsuccessful.
 
Event Description
On (b)(6) 2012, it was reported that no patient manipulation or trauma was known to have preceded the high impedance event. The explanted lead was received on (b)(6) 2012. Product analysis was approved on (b)(6) 2012. The reported fracture of lead allegation was not verified within the returned lead portion. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the discolored region noted in the vicinity of the coil cut end. The exact reason for this condition is unknown. Also, it was verified that the coil was cut. The lead assembly had remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. No obvious point of entrance was noted other than the cur end of the returned lead portion. Four sets of setscrew marks were seen on the connector pin, provided evidence that proper contact between the setscrew and the lead pin existed at least once. Note that since a portion of the lead (including the electrode array) 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 typical wear and explant related observation, no other anomalies were identified in the returned lead portion.
 
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.
 
Manufacturer Narrative
Device failure is likely, 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=2676357
« Last Edit: October 02, 2018, 12:27:39 AM by dennis100 » Logged
dennis100
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« Reply #1 on: August 02, 2018, 08:38:02 AM »

Model Number 102
Event Date 01/01/2006
Event Type  Injury   
Event Description
It was initially reported the pt had lack of efficacy with the vns so it was decided to keep their therapy disabled. Additional information was received from the pt's treating physician that their vns therapy was disabled in 2006 due to swelling around the nerve and possible interference with his pseudobulbar palsy. Good faith attempts are being made for additional details surrounding the nerve swelling. Thus far no further information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1292037
« Last Edit: October 02, 2018, 12:28:39 AM by dennis100 » Logged
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« Reply #2 on: August 02, 2018, 08:38:42 AM »

Model
« Last Edit: December 26, 2018, 12:41:30 PM by dennis100 » Logged
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« Reply #3 on: August 02, 2018, 08:39:31 AM »

Model Number 102
Event Date 03/12/2016
Event Type  Death  
Manufacturer Narrative

Event Description
In the (b)(4) 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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. Analysis in the (b)(4) lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.
 
Event Description
Death certificate and the autopsy results were received indicating that the patient's immediate cause of death was hypertensive cardiovascular disease. The manner of death is natural. The patient died while in hospice care. Patient's medical history is significant for congestive heart failure, liver and kidney failure, (b)(6), mental retardation and dementia. Patient also has a clinical history of seizure disorder. Per the autopsy results, the heart is markedly enlarged and globular with four-chamber dilatation and diffuse endocardial fibrosis of the left ventricle. The lungs are edematous, and the right lower lung lobe is collapsed, the liver is mottled. The right kidney has marked cortical pitted scars consistent with remote infarction or possible chronic pyelonephritis. A vagus nerve stimulator is in place. As such, the cause of death is hypertensive cardiovascular disease. Hepatitis c is a contributory cause.
 
Event Description
It was reported that the patient was admitted to the icu due to seizures. The nurse at the icu reported that the patient grabs at the area of vns but is unable to communicate the issue due to pre-existing conditions. Due to this, a device issue is suspected and the nurse was informed about the use of magnet in disabling the stimulation and referred to patient's neurologist who can disable the device. Additional information was received from the nurse at the icu about patient's admission on (b)(6) 2016 due to nausea and vomiting. On (b)(6) 2016, patient experienced seizures. At night around 1 pm on (b)(6) 2016, patient grabbed the left chest at the generator site and reported pain. Patient was given pain medication and the magnet was not used to disable the device. On (b)(6) 2016, patient reported pain again around 4 pm. Patient was reported to have been discharged after (b)(6).
 
Event Description
The explanted devices were received for analysis on 05/02/2016. Since a significant portion of the lead (including the electrode array) 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. Analysis of the generator is underway and has not been completed to date.
 
Event Description
Additional information was received that the patient had passed away on (b)(6) 2016. The patient's devices were explanted on (b)(6) 2016 by the medical examiner's office but have not been received to date. Patient was re-admitted in to (b)(6) hospital around (b)(6) 2016 due to experiencing seizures. After seizures, patient clutches the generator site and complained of pain. According to the treating physician, this has occurred several times. The hospital requested the device be checked and a field representative performed interrogation and diagnostics. The physician was informed about using the magnet to disable the patient's device and was asked to contact the patient's neurologist for further instruction. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The autopsy results were requested from the medical examiner's office but were not received to date as the autopsy is not yet completed.
 
Manufacturer Narrative
Additional manufacturer narrative and/or corrected data: supplemental report #1 inadvertently omitted the identifiers of the corrected data fields, which were (describe event or problem) and (relevant tests/laboratory data, including dates) regarding details of the patient¿s hospital admission and device diagnostics respectively.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549413
« Last Edit: September 11, 2018, 02:44:58 AM by dennis100 » Logged
dennis100
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« Reply #4 on: August 02, 2018, 08:40:14 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/06/2018
Event Type  Injury  
Manufacturer Narrative

Event Description
It was reported that the patient developed edema at the electrode site and a rapid heart rate following a generator replacement. The physician programmed the device off. Information was obtained from the physician that the cause of the rapid heart rate was due to the body's reaction to the surgery. It was also stated that the patient was developing an infection at the generator site due to patient picking. The physician is treating the site before beginning therapy. The device history records of the generator and lead were reviewed, and the devices were sterilized according to procedure prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7390605
« Last Edit: September 11, 2018, 02:44:39 AM by dennis100 » Logged
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« Reply #5 on: August 02, 2018, 08:40:59 AM »

Model
« Last Edit: January 21, 2019, 11:34:20 AM by dennis100 » Logged
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« Reply #6 on: August 02, 2018, 08:41:50 AM »

Model Number 302-20
Event Date 07/27/2011
Event Type  Injury  
Event Description
Additional information was received on (b)(6) 2011 when it was discovered that the vns patient was scheduled for a full revision surgery on (b)(6) 2011. The manufacturer's consultant reported that the diagnostics prior to surgery were within normal limits and the diagnostics after the replacement surgery were also within normal limits. No breaks in the tubing were noticed during the revision good faith attempts for product return have been made but the explanted product has not been returned to the manufacturer for product analysis to date. An investigation was initiated in response to the identification of aspire generator hardware design issue. As a result of this design issue, a portion of the stimulation output delivered by the generator through the lead to the positive electrode may be unintentionally redirected to the generator-can away from the intended path, i. E. , through the vagus nerve and then to the negative electrode. As a result the stimulation current intended for the vagus nerve is less than what is programmed by the physician. In addition, the current diversion may cause a charge imbalance at the lead cathode and generator-can during stimulation. Thus, the device does not meet its design intent. The magnitude of these effects is dependant upon patient programmed settings and physiology. As a result of the charge imbalance, it is possible for localized ph changes to develop leading to pain, inflammation and edema formation. In this instance, though it is possible that a charge imbalance may have been present based upon patient programmed settings, the reported event of painful stimulation does not appear to be related to the m105 design issue because the onset of painful stimulation did not occur until two weeks after the patient's device was programmed on following generator revision surgery. The presence of neck pain, inflammation and swelling/edema that may occur as a result of this generator design issue are expected to be noted shortly, possibly as soon as 24-48 hours, after initiating stimulation at a combination of output currents and on-times that lead to an injected charge that is higher than the electrodes charge storage capacity. Also, the patient's lead had been implanted for approximately 3 years prior to the onset of the painful stimulation, thus there has been ample time for tissue encapsulation, or fibrosis, to develop between and, more importantly, around the electrode and the nerve. The presence of this encapsulation is expected to significantly reduce the diversion of current from the positive electrode to the generator- can due to its resistivity, making the charge imbalance issue negligible. Lastly, patient tolerability issues were present, even when the device was programmed to an output current setting of output=0. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min. The current diversion/charge imbalance issue associated with this investigation will not occur at these settings.
 
Manufacturer Narrative

Event Description
On (b)(4) 2011, a vns treating physician reported that the vns patient recently had a prophylactic battery replacement on (b)(6) 2011 and while gardening on (b)(6) 2011, the patient experienced painful stimulation in her neck every time the device stimulated. The patient taped her magnet over the device and was seen by the physician on (b)(6) 2011. Diagnostics were performed which showed results within normal limits, specific results not provided. The physician decreased the patient's output down to 3ma, then 2ma, but the patient still could not tolerate the pain so the device was eventually turned off. The physician is worried that there is something wrong with her vns. There was no trauma or manipulation to the device. The patient was programmed back up to original settings on date of implant. The patient's settings were output=3. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min. On (b)(6) 2011, the physician performed normal mode diagnostics with patient set to an output of 0. 25ma and results were within normal limits with an impedance value of 1677 ohms. The physician then performed system diagnostics and the results were within normal limits with an impedance value again of 1677 ohms. The consultant was concerned because the impedance value remained the same. A copy of the patient's programming history was requested for review by the manufacturer. The programming history was reviewed by the manufacturer and it seems possible that the same impedance measurement could be obtained several times in a row, especially when the diagnostics are performed back to back within a short time frame. Everything in the diagnostic data appears that the device is operating correctly, and the lead impedance value is normal. Clinic notes from the physician were received. The clinic notes were dated (b)(4) 2011 and revealed that with the patient's first vns generator, he never experienced any difficulties and had an excellent response. The physician reports that it is presumed that she has had a lead break that is not able to be picked up running the diagnostics. Even on an output of 0. 25ma, the patient still had a severe amount of pain and felt as though his esophagus was closing. The physician reported that the device is disabled and he is referring him for a full revision surgery. Although surgery is likely, it has not yet occurred. When additional information is received, it will be reported.
 
Event Description
Additional information was received on (b)(6), 2011 when the physician reported that they did not perform x-rays on the patient. Although surgery is likely, it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2220076
« Last Edit: September 11, 2018, 02:44:07 AM by dennis100 » Logged
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« Reply #7 on: August 02, 2018, 08:42:29 AM »

Model Number 106
Event Date 04/12/2016
Event Type  Injury  
Event Description
It was reported that a patient that was recently implanted with vns was hospitalized due to an infection that required removal of the vns system. Clinic and operative notes were received on 04/21/2016 regarding the patient's infection. The patient had vns implant surgery on (b)(6) 2016 and was admitted to the hospital on (b)(6) 2016 due to nausea, chills, pain at the neck and chest incisions, odynophagia, and pain while moving her neck. The patient started having drainage at the neck area. After the patient was admitted to the hospital, it was determined that the patient had fever, tachycardia, and leukocytosis. There was evidence of inflammatory changes/edema in soft tissue of the left check and neck. The patient was diagnosed with sepsis secondary to left chest wall cellulitis. The patient's vns system was explanted on (b)(6) 2016 due to the infection. The patient was treated with antibiotics for a streptococcus pyogenes (group a). The patient was admitted to the hospital for surgery on (b)(6) 2016 due to "issues" with her incision. The patient was experiencing wound dehiscence at her neck incision after her vns system was explanted. Irrigation and debridement of the cervical wound and a revision of the wound was performed. It was not known if the wound dehiscence was a continuation of the previous infection, but it was stated that it could have been due to possible poor wound healing. The device history records of the lead and generator were reviewed, and both were sterilized according to procedure prior to release.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Ct scans performed during the patient's visit on (b)(6) 2016 were provided on (b)(6) 2016. The indication for the ct scan was recent removal of implant for seizures with draining incision in the neck. The ct of the chest identified focal induration within the left breast which was nonspecific. There was no pathologically enlarged adenopathy or mass. In the neck. There was no evidence of discrete fluid collection or mass. The ct of the neck identified a small air-filled cavity in the anterior aspect of the neck along the medial aspect of the left sternocleidomastoid muscle. There was no discrete fluid collection to suggest abscess. The patient also had a picc line placed from the right arm for the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5655090
« Last Edit: September 11, 2018, 02:43:49 AM by dennis100 » Logged
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« Reply #8 on: August 02, 2018, 08:43:11 AM »

Model Number 102
Event Date 10/24/2011
Event Type  Injury  
Event Description
Clinic notes dated (b)(6) 2011 reported that the pt had clusters of seizures the two weeks prior, which was noted to be an increase in seizures. The physician felt that the seizures may be more frequent because the generator needed to be replaced. The pt's caregiver reported that the pt had more than 20 seizures. He received rectal diastat to terminate the seizures. Ems gave him iv ativan, and the seizures stopped. It was also noted that the pt was recently diagnosed with angioedema. The caregiver wondered whether the increase in seizures could have been related to angioedema. The physician suggested to keep the medications the same, but to increase if he experiences a cluster of seizures. In notes dated (b)(6) 2011, it was noted that the pt was hospitalized six weeks prior in (b)(6) 2011, but he had not had any seizures since the hospitalization. Follow up with the physician's office revealed that the pt's caregiver took the pt to the er due to a very bad seizure in (b)(6) 2011, as previously reported in mfr report number: 1644487-2011-02940. The pt had generator replacement surgery on (b)(6) 2011. The implant card was received and indicated the reason for replacement due to battery depletion with near end of service=yes. The generator was received by the mfr. The product analysis was completed and approved on (b)(6) 2012. No anomalies were noted during the analysis. The reported end of service was not duplicated. However, the elective replacement indicator (eri) was set. The battery was partially depleted and determined to be the result of normal expected battery consumption. There were no performance or any other type of adverse conditions found with the pulse generator. Since the generator was found to not be at end of service, attempts for add'l info concerning the pt' increased seizures have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2459570
« Last Edit: September 11, 2018, 02:43:32 AM by dennis100 » Logged
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« Reply #9 on: August 02, 2018, 08:43:58 AM »

Model Number 302-20
Device Problem Mechanical issue
Event Date 11/23/2015
Event Type  Malfunction  
Event Description
The patient has been referred for a prophylactic generator replacement but before replacement surgery, the surgeon noticed inflammation in the neck area, near the lead placement. Before the patient was referred to surgery, they were being seen by a dermatologist who noticed a mass in the left neck, with no signs of infection. The dermatologist noted it to be a rapidly growing pyle on the left neck, suspect for pyogenic granuloma. A biopsy of specimen was taken and it came back as an "inflamed fibroepithelial polyp with hemosiderin deposition and edema. " at a follow-up appointment the dermatologist mentioned the mass to be an "8 mm flesh colored nodule on left neck - regrowth within three weeks" and the patient was injected with steroid at that time. At yet another follow up appointment, the mass bled with minimal trauma, therefore an excisional biopsy was taken and it returned as a pyogenic granuloma, with 1. 2cm at it's largest dimension. A later follow up revealed that healing occurred. The patient was referred to ent as the regrowth returned. A ct scan was done and it was reported "within skin overlying the surgical site, there is no enhancing contour with irregularity, also stable in size. This may represent a pyogenic granuloma as offered in the indication; also consider keloid/hypertrophic scar. There is no enhancement to suggest abscess". The surgeon mentioned that there was inflammation but no sign of infection where the lead is located. The epicenter of inflammation was located near the tie down. The surgeon was unable to determine whether the cause of inflammation was due to previous injections, incisions, the lead (which showed compromised insulation), or the tie downs. There was no obvious pus, but cultures were taken. Due to the inflammation the generator and a portion of the lead were explanted. The lead was cut and the surgeon left a small stump proximally in case re-implantation was needed. The removal site was washed out and the generator was removed in case no further implant is necessary. The patient was then put on antibiotics. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The explanted products have not been received to date.
 
Manufacturer Narrative

Event Description
Additional information was received from the doctor indicating that the exact cause of compromised insulation is unknown. It was stated that there was fibrosis and granulation around the tissues, and the source of the granulation seemed to be the tie down. However it is notable that multiple steroid injections and biopsies were performed over the site. Therefore the doctor cannot be certain at which point, and during which surgeries, the lead insulation was compromised. No other relevant information has been received to date.
 
Event Description
System diagnostics were received for the device and indicate no lead fracture. The explanted products have not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6868430
« Last Edit: September 11, 2018, 02:43:16 AM by dennis100 » Logged
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« Reply #10 on: August 02, 2018, 08:44:38 AM »

Model Number 302-20
Event Date 06/01/2008
Event Type  Injury  
Event Description
It was reported by a surgeon that a vns pt experienced voice disturbance that occurred approx 6-7 months after her vns surgery. The pt recently had a videostrobe which revealed improved glottic closure. The true vocal fold did appear temporarily fixate during active stimulation by the vns implant. Add'l info was received through clinic notes dated (b)(6) 2008 in which the pt reported verbal hoarseness. At the following appt on (b)(6) 2008, the pt reported headache after the device was adjusted vocal cord edema and verbal hoarseness. Hoarseness of voice was noted on (b)(6) 2008. On (b)(4) 2008, it was indicated, the pt experienced left vocal cord paralysis. The vocal cord was injected with a gel to prevent choking. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1894942
« Last Edit: September 11, 2018, 02:42:57 AM by dennis100 » Logged
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« Reply #11 on: August 02, 2018, 08:45:16 AM »

Model Number 105
Event Date 01/01/2010
Event Type  Malfunction  
Event Description
During the evaluation of data from a clinical investigational device (model 106 aspiresr generator) used in a (b)(4) study, cyberonics identified a hardware design issue that can cause a portion of the stimulation output to be redirected from the intended path. Like the investigational device, the same circuit configuration is also present within the model 105 aspirehc generator which is a commercially marketed device. (refer to manufacturer report number 1644487-2011-02121 for the model 106 event). As a result of this issue, the stimulation current actually delivered to the vagus nerve can be less than what is programmed by the physician. This diversion of stimulation current can potentially lead to the following pt effects: delivery of stimulation current that is less than the magnitude required for effective therapy. Presence of neck pain, inflammation and/or swelling/edema at the lead electrode location in the neck; and/or pt perception of unusual stimulation or muscle twitching between the pulse generator and the lead electrodes implanted in the neck. The magnitude of the diverted current and its consequences depends on the pt's programmed parameters settings and physiology, tending to manifest only as the pt's programmed parameters (output current, pulse width, frequency, and on time) reach higher parameters. No pt injury has been reported as a result of this particular event. Cyberonics will be sending recommendations on programming to treating physicians who have pt's implanted with the model 105 generator. Cyberonics recommends that physicians continue their practice of titrating programming parameters for pts implanted with an aspirehc generator to achieve appropriate clinical outcomes, paying particular attention to reports of: lack or loss of efficacy. Pain, inflammation, swelling/edema in the neck area; and/or pt perception of stimulation or muscle twitching in the area surrounding the implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266742
« Last Edit: September 11, 2018, 02:42:42 AM by dennis100 » Logged
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« Reply #12 on: August 02, 2018, 08:45:51 AM »

Model Number 102
Event Date 05/06/2010
Event Type  Injury  
Event Description
It was reported that a vns pt experienced swelling from the left shoulder to the hip area. The treating neurologist believes, the swelling is related to vns therapy as there has not been any reported trauma to the area. Moreover, the treating neurologist believes the event is related to mal-position of vns at it could be pressing on the pt's venous system. The pt is non-verbal and the swelling started 3-4 weeks prior to report. System and normal mode diagnostics were ok/ok/2/no and ok/ok/6/no; pt current settings are 3. 5/30/250/21/0. 5. Current interventions planned were to have an ultrasound and refer the pt for eval with the surgeon. Follow-up with the surgeon's office indicated that no surgical intervention has been done on the pt other than testing. No further follow-ups have been scheduled at the moment with the surgeon.
 
Manufacturer Narrative
Brand name, corrected data: manufacturer inadvertently listed incorrect brand name. Model #, corrected data: manufacturer's initial report listed incorrect model number. Serial #, corrected data: manufacturer's initial report listed incorrect serial number.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1772212
« Last Edit: September 11, 2018, 02:42:27 AM by dennis100 » Logged
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« Reply #13 on: August 02, 2018, 08:46:25 AM »

Model Number 103
Event Date 07/01/2010
Event Type  Injury  
Event Description
It was reported by a nurse that a vns pt experienced hypoxia after a programming session with her treating neurologist. The nurse indicated the pt's oxygen level dramatically dropped and was placed on oxygen after the vns programming. At the moment the nurse is not able to tell if the condition is exacerbated by vns; however, the pt's seizures are very well controlled since vns implant. Additional info was received from the treating neurologist indicating the pt a current conditions of tracheostomy, recurrent pneumonia and edema. However, the neurologist still increased the pt's settings. Moreover, at the moment it is likely that vns stimulation is exacerbating the current medical conditions of the pt. However, clear evidence has not been provided to confirm vns is a direct contributory factor for the reported hypoxia. Lastly, current diagnostics indicate the device is working within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1833655
« Last Edit: September 11, 2018, 02:42:10 AM by dennis100 » Logged
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« Reply #14 on: August 02, 2018, 08:47:05 AM »

Model Number 302-20
Event Date 10/06/2010
Event Type  Malfunction  
Manufacturer Narrative
Device failure is suspected.
 
Event Description
Reporter indicated a vns pt had recurrent swelling and pain at the vns generator site. Fluid from the site was previously aspirated, but continued to recur. Cultures of the fluid did not identify any infection, and the incision site did not appear to be infected. The pt later had exploratory surgery of the vns generator site, where it was noted the vns generator header was corroded, and the vns led pin appeared to be "soft" and the lead appeared "weakened". High impedance was obtained with a new vns generator and the resident lead, indicating a lead fracture was likely. The generator and lead were removed, and no new devices were implanted. Prior to surgery, it was noted the generator was at eos = yes, indicating generator end of svc, and vns diagnostics were unable to be completed due to the suspected depleted battery. The depleted battery is likely premature, as a battery estimate indicated over 8 yrs remaining. The premature end of svc is likely due to the generator header corrosion, and the header corrosion is likely due to the lead fracture. F/u with the treating neurologist revealed vns device diagnostics in (b)(6) 2010 were within normal limits, the pt had no known trauma, and did not manipulate the vns. F/u with the reporter revealed the pt is healing well. It is likely a new vns sys will be implanted when the pt has fully recovered. Attempts for return of the explanted devices have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1893348
« Last Edit: September 11, 2018, 02:41:53 AM by dennis100 » Logged
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« Reply #15 on: August 02, 2018, 08:47:39 AM »

Model Number 103
Event Date 11/02/2010
Event Type  Injury  
Event Description
It was initially reported by the physician that the patient was having swelling and pain at the incision site. Patient had developed an infection and the surgeon prescribed antibiotics. Blood work has been ordered for the patient and they were referred to infectious disease. Good faith attempts to gain more information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936651
« Last Edit: September 11, 2018, 02:41:37 AM by dennis100 » Logged
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« Reply #16 on: August 03, 2018, 12:28:17 AM »

Model Number 300-20
Event Date 10/19/2010
Event Type  Malfunction  
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by neurologist that vns pt developed massive swelling at the generator site post operatively after undergoing generator replacement surgery which resolved over 5 days time. The neurologist indicated that there were no signs of infection at the site. Diagnostics at the pt's office visit with the neurologist indicated pt is receiving 0. 75ma when he was programmed to 2. 0ma. On (b)(6), pt's impedance was 6000 then increased to 8061 (b)(6) ohms and then on (b)(6) was 10,000 ohms. Moreover, the neurologist indicated that the surgeon did not notice a problem with the diagnostics at the time of re-implant surgery. The surgeon, however, stated he observed extensive fibrosis around the generator and attributed it to the presence of the vns device. Follow-up with the pt's treating nurse indicated that no pt manipulation or trauma had occurred and no x-ray was taken. The neurologist has referred the pt for another revision surgery; however, surgery date hasn't been scheduled yet.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1940530
« Last Edit: September 11, 2018, 02:41:22 AM by dennis100 » Logged
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« Reply #17 on: August 03, 2018, 01:11:09 AM »

Model Number 103
Event Date 11/02/2010
Event Type  Injury  
Event Description
It was initially reported by the physician that the patient was having swelling and pain at the incision site. Patient had developed an infection and the surgeon prescribed antibiotics. Blood work has been ordered for the patient and they were referred to infectious disease. Good faith attempts to gain more information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936651
« Last Edit: September 11, 2018, 02:41:04 AM by dennis100 » Logged
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« Reply #18 on: September 03, 2018, 01:42:18 PM »

Model Number 102
Event Date 06/18/2011
Event Type  Injury   
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the lead and generator prior to distribution.
 
Event Description
On (b)(6), 2011, the vns implanting surgeon reported that the vns pt had his vns explanted on (b)(6), 2011 due to an (b)(6) infection. They were unaware of any plans to replace it. The surgeon's nurse reported that the vns pt went to the er on (b)(6), 2011 for swelling and pain of the incision sites on the neck and chest. The pt was then placed on oral antibiotics. On (b)(6), 2011, the pt saw their surgeon and the infection has not gotten any better since their er visit two days prior. The surgeon prescribed stronger antibiotics and explained to the pt that if they don't feel better in 12-24 hrs, to visit the surgeon again. The pt was hospitalized on (b)(6), 2011 for the infection and placed on iv antibiotics of vancomycin and aosyn. Cultures of both sites were taken at that time and the infection was discovered to be (b)(6). The pt was explanted on (b)(6), 2011 because of the infection. The surgeon's nurse reported that it is unclear at this time if the infection is related to the vns device or a problem with the surgery. The pt is very alert and did not touch or scratch the site and no trauma was noted that could have caused/contributed to the infection. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution. If further info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180925
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« Reply #19 on: September 04, 2018, 08:32:10 AM »

Model Number 102
Event Date 06/02/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 the vns pt reported to the case manager that she had felt poorly and that her chest and neck were real swollen and painful so she went to the hospital and it was discovered that she had a post op infection of her incisions. The pt said that she was unclear of the dates when this occurred but that she thinks she was in the hospital from about (b)(6) 2011 to (b)(6) 2011. The physician later reported that the pt had no infection; that she was admitted for a different medical complaint. No further info regarding the medical complaint was provided. He said that the pt has normal post op results. Good faith attempts for info regarding why the pt was hospitalized; specifically its relationship to vns, have been to no avail thus far. If additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2167116
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« Reply #20 on: September 04, 2018, 08:32:51 AM »

Model Number 103
Event Date 06/04/2011
Event Type  Injury   
Event Description
It was reported to our distributor in (b)(4) that there was a vns pt who has an infection. It was reported that the parents noticed that pt's left neck skin became red and swollen. The swelling extended to thorax. The pt had an operation on (b)(6) 2011 to drain the pus, in addition to antibiotic medication therapy. They had a total of 5 surgeries to drain pus. The diagnosis is (b)(6) infection, antibiotic resistant bacterial infection. The infection condition has not resolved and a decision to remove the generator and lead has been made. The pt's physician does not think their infection was vns related. The infected wound he suspects from mosquito bite, which pt scratched and had an open wound.
 
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2160568
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« Reply #21 on: September 05, 2018, 08:16:49 AM »

Model Number 105
Event Date 07/18/2011
Event Type  Injury   
Event Description
It was reported that the vns patient was being treated for what was believed to be an infection at her generator site. The infection supposedly was first noticed on (b)(6) 2011. The reporting physician indicated that he no longer believes that the patient is experiencing an infection because her lab results and symptoms no longer indicate an infection and she is on high doses of high antibiotics however the patient is not getting better. When evaluating the wound on (b)(6) 2011, the physician noted that there was no pus or other signs indicative of an infection besides redness and swelling. The physician believes that the patient's body may be reacting adversely to the material of the generator however she did not have this issue with a previous vns implant. Additional information was later received indicating the patient's generator has reportedly been explanted as a result however this has not been confirmed with the site.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2235077
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« Reply #22 on: September 07, 2018, 10:51:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/18/2018
Event Type  Injury   
Event Description
It was reported that this patient received a generator replacement and did not remove his bandage for 7 days post-surgery and the generator site became infected. Additional information was received that the patient had a three day history of pain and redness. The incision site was red, inflamed and swollen, and therefore the surgeon admitted the patient for removal of the battery. It was stated that the patient's device was explanted due to the infection, which was stated to be mrsa. A review of device history records showed that the implanted generator was sterilized prior to distribution. All other quality tests also passed prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No other relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? code 81: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7751663
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« Reply #23 on: September 07, 2018, 10:51:56 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/12/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
The patient's device was removed due to infection. The patient's incision site was tender to touch, and had redness and swelling. The surgeon decided to drain the site and then remove the device. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7783469
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« Reply #24 on: September 07, 2018, 10:52:30 AM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/05/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient who was recently implanted has swelling and drainage at the neck incision. The patient was on antibiotics and iv. Cultures were taken for the neck incision to determine whether or not this is an infection but came back negative. The patient was sent home with a pic line and anticipates receiving iv antibiotics for 4-6 weeks. Design history records for the generator and lead were reviewed and showed that both devices were hp sterilized prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7769980
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« Reply #25 on: September 07, 2018, 10:53:04 AM »

Model Number 302-20
Device Problem Fracture
Event Date 07/19/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient has high lead impedance and is scheduled to receive a full lead revision. Clinic notes were received providing that the area over the vns device is swollen and tender, and the patient is having pain around the left vagus nerve area in the neck. The device was turned off. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7759183
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« Reply #26 on: September 07, 2018, 10:53:54 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
Follow up with the company representative revealed that the extracted lead portion had been discarded.
 
Event Description
It was reported that the patient was experiencing swelling in the neck. The physician was unsure if it was related to vns and referred the patient for x-rays in order to further assess the swelling. The swelling was reported as constant and unrelated to stimulation. The lead impedance was reported as within normal limits. Follow up with the physician revealed that there was no trauma or patient manipulation to the area. The physician did not think the swelling was related to the vns, but due to the asymmetry of the swelling, which was only on the vns side of the neck, they were unable to rule it out. The swelling was not associated with stimulation. There was no interventions planned or taken at that time. It was later reported that the patient's neck swelling had gone down and the patient was asymptomatic with no pain or discomfort. X-ray images were received by the manufacturer and reviewed. The lead visibility varies throughout the length of the lead visible in the provided images as only the neck x-rays were provided. The review was unable to assess if strain relief was present and placed according to labeling due to the unorganized placement of the lead in the neck. The review was able to identify only one tie-down. No apparent sharp angles or gross fractures were identified in the visible portions of the lead. The patient's previous lead could be observed in the image. Based on the x-rays received, the cause for the swelling cannot be determined. It was later reported that the patient was complaining of something not being right. The patient the proceeded to pull a two inch piece of the remaining lead left over from the previous lead revision. The patient believed it was an ingrown hair and pulled it out with tweezers. It was stated that it came out without pain and that the patient has not had further issues. The medical professional believed that the previous edema was caused by the remaining portion of the previous lead. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7740319
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« Reply #27 on: September 09, 2018, 01:11:12 AM »

Model Number 102
Event Date 09/01/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
 
Event Description
Good faith attempts for more information have been unsuccessful to date.
 
Event Description
It was initially reported that the patient was experiencing intermittent painful stimulation. The patient had some swelling and redness on her chest. The patient was on her way to the emergency room at the time of the report. The patient had not been disabled but disablement was likely. Last diagnostics at the time of the report were within normal limits. No further information know regarding these events, when more information is known it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2262660
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« Reply #28 on: September 09, 2018, 01:11:50 AM »

Model Number 102
Event Date 07/03/2011
Event Type  Injury   
Event Description
It was initially reported that the patient was experiencing burning pain and swelling at their generator site. The pain is continuous and there was no reported trauma. The pain began one morning and continued to get worse until the generator was disable by the physician. The pain and swelling have resolved since device disablement. Diagnostic have not been perform since the device was disabled and there was concern that it would cause the patient pain. The patient was looking into possible vns replacement but that is not an option currently as medicare will not cover the surgery. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2193844
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« Reply #29 on: September 10, 2018, 08:07:26 AM »

Model Number 304-20
Event Date 08/25/2011
Event Type  Injury   
Event Description
It was reported by the surgeon that the patient had to go back to the operating room to re-secure the lead and remove a tie-down that was protruding beneath the skin. Follow-up with the surgeon's office found that the patient had inflammation in her left neck and swelling. The tie-down was protruding through the skin; however, no skin rupture had occurred. It was noted that the patient skin is naturally thin at electrode site likely leading to the protrusion and irritation. At a recent follow-up visit, the patient's mother stated that the wound site appeared to be getting worse after it had been healing well. The surgeon noted that there was only redness and no other signs of infection; however, the patient was given a refill of antibiotics as a precaution. No infection is believed to be present at this time; however, the surgeon's office will contact the manufacturer if an infection is believed to be present. No trauma or manipulation has been reported.
 
Event Description
Additional information was received stating that the vns patient will not be re-implanted. The surgeon suggested that the patient should wait a few years before being re-implanted to allow the patient to grow. The patient was prescribed new medication by her neurologist and reported to be doing fine.
 
Manufacturer Narrative

Event Description
Additional information was received indicating the remainder of the vns lead has been explanted. The rest of the lead was returned and underwent analysis. No anomalies were observed in the newly returned portion of the lead.
 
Event Description
Additional information was received indicating that the patient will likely be reimplanted. Surgery has not occurred to date.
 
Event Description
Analysis of the explanted vns lead and generator has been completed. The electrode portion of the lead was not returned. No anomalies were observed in the returned portion. Analysis of the generator found no anomalies and it performed to specifcations.
 
Event Description
Additional information was received from the physician indicating that the extrusion and possible infection were a result of the patient picking at her wounds. The patient had two surgeries to relocate the lead further underneath the patient's skin however the extrusion issues persisted. The surgeon eventually decided to explant the patient's vns lead and generator. Cultures were taken to rule out a possible infection however the results have not been provided at this time. The explanted products have been returned and are currently undergoing analysis. The return product form received with the explants indicated that the "lead was starting to come out of skin. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2260227
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