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Author Topic: Misc. Respiratory  (Read 306488 times)
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dennis100
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« Reply #870 on: August 26, 2018, 01:49:01 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2017
Event Type  Injury   
Event Description
It was reported that a patient who had bronchitis did not tolerate vns stimulation well due to bradycardia occurring for the patient during stimulation on times. It was noticed during an eeg for the patient that the bradycardia occurred exactly every 3 and a half minutes which corresponded with the vns on time. It was advised to decrease the pulse width and frequency however it is not known if these changes were made. No additional relevant information has been received to date.
 
Event Description
This event was found to have been previously reported in manufacturing report # 1644487-2017-05093. The patient and device information was received confirming that the report in this file was a duplicate of the report. All further information regarding the events for the patient will be reported in manufacturing report # 1644487-2017-05093.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187658
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dennis100
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« Reply #871 on: August 26, 2018, 01:50:15 AM »

Model Number 103
Event Date 04/05/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's devices were explanted less than a month from initial implant on (b)(6) 2016 due to infection. Patient is on a 6-8 week antibiotic therapy to clear infection. A review of device history records showed that both the lead and generator were sterilized prior to distribution.
 
Event Description
Additional information was received that the patient is experiencing hoarseness and coughing which began shortly after the explant surgery. It was initially thought to be bronchitis, but they now believe it to be related to the explant surgery. The patient has been referred to see an ent to assess the adverse events. Patient's hoarseness and coughing had not resolved and patient was provided medication for bronchitis and reflux. Patient saw a pulmonologist on (b)(6) 2016 who stated that the patient developed acute bronchitis. The cause of the bronchitis is unknown. Patient had a pre-existing diagnosis of asthma prior to implant surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5659628
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dennis100
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« Reply #872 on: September 01, 2018, 01:30:15 AM »

Model Number 304-20
Event Date 07/08/2011
Event Type  Injury   
Event Description
It was reported by an ent surgeon that a vns pt was having dyspnea, paresis, and voice alteration. The voice alteration and paresis were occurring with vns stimulation and pt's vocal cords would get immobilized. However, her vocal cords would return to normal function after vns stimulation stopped. Additionally, the physician stated that at times, the pt's vocal cords get constricted so severely during the on times that it cuts off her breathing. This condition gets worse during exercise for pt. Pt has been having a great seizure control with vns therapy and would like to keep the vns turned on. The pt's generator's diagnostics were within normal limits on (b)(4) 2011. During (b)(4) 2011, pt complained that her throat was bothering her but did not want the setting lowered. During the next appointment on (b)(4) 2011, pt's settings, pulse width and frequency were lowered and pt's pain was resolved. Mfr received and reviewed the x-rays. The alignment of the positive and negative electrodes appeared to be normal. The lead was routed towards the generator. The generator was placed on the left chest and a small amount of lead was placed behind the generator. The connector pin could not be assessed since the generator was only partially visible in the x-ray images. However, the filter feed-thru wires appeared to be intact. Based on the x-ray images received, no obvious anomalies could be identified in visualized portion of the pt's vns device.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2192435
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dennis100
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« Reply #873 on: September 02, 2018, 01:13:36 AM »

Model Number 102
Event Date 08/15/2010
Event Type  Death   
Manufacturer Narrative

Event Description
The cause of death was listed as pneumonia, septicemia, cardiac arrest, shock. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician indicated that the patient experienced, a reduction in seizures with vns therapy. The patient was receiving therapy at the time of death. The cause of death was listed as paraplegia with respiratory failure. It was noted that no autopsy was performed and the death was not believed to be related to vns therapy. The patient was compliant with medications and suffered respiratory arrest at the time of death.
 
Event Description
It was reported that the vns patient passed away. The cause of death and relationship of the death to vns are unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4281651
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dennis100
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« Reply #874 on: September 07, 2018, 11:15:08 AM »

Model Number 102R
Device Problem High impedance
Event Date 02/05/2018
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was stated by the neurologist office that the patient passed away. The office did not have any records as to the exact date or the circumstances of his death. Per death certificate, the cause of death was listed as cariopulmonary arrest, acute respiratory failure, and pneumonia. No additional relevant information has been received. High impedance was observed for patient's device prior to patient's death. This is reported in mfr. Report # 1644487-2018-01508.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7824973&
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dennis100
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« Reply #875 on: September 07, 2018, 11:15:57 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Injury   
Event Description
A patient reported side effects of extreme pain in the sternum/chest, nausea, difficulty swallowing, and any gas belching can¿t come up. He also reported sharps pains and happens when trying to eat. He also mentioned that he can¿t swallow as if there is a blockage in the middle. He also stated that there is a jolting nerve type of pain going through the left shoulder and biceps where the muscle meets the collar bone. He stated that it doesn¿t happen all that much. A couple of years ago, he also mentioned pain with hiccups, that happened when eating. It used to be hit or miss, but is getting to where can¿t breathe when trying to eat. He stated that the issue was lasting longer than 5 minutes. He stated that there are sometimes when looking to the left, can feel it, but not that often. The patient later reported on (b)(6) 2018 that he had shortness of breath, pain in chest and neck, and has difficulty swallowing. These symptoms started 2 months prior but have gotten worse and the pain was so bad that he went to the er. He reports that he wants the device removed. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7827569
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dennis100
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« Reply #876 on: September 07, 2018, 11:16:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that the patient's seizures had worsened following a change in settings. It was reported that the settings were changed due to the patient experiencing breathing problems since being implanted with vns. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7775634
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dennis100
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« Reply #877 on: September 08, 2018, 12:53:44 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a company representative that a patient presented to the physician's office with respiratory dysfunction. It was reported by the group home this had been occurring for about 2 months. The diagnostics were within normal limits. It was also noted the patient had recently undergone a generator replacement. Follow-up to the provider indicated the respiratory issues were directly attributable to anesthesia, prior issues with respiratory, and advanced age of the patient. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7802591
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dennis100
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« Reply #878 on: September 11, 2018, 03:02:58 AM »

Model Number 102
Event Date 09/26/2011
Event Type  Injury   
Event Description
It was later reported the patient would like to have her device explanted because the vns isn't helping and hasn't helped in years. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
Information was received indicating that the patient had his device disabled. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.
 
Event Description
Additional information was received from the patient stating why he wants the vns removed. He states it is not helping his severe depression, it adversely affects his speech when it¿s cycling, it increases his social anxiety because he is concerned it will start cycling when he speaks, and he states the device makes it difficult to breathe when he exercises. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.
 
Event Description
It was initially reported that the patient had requested that the generator be disabled. The patient had reported to the physician that she felt that her depression has been worse since having vns. The physician that reported the event's to the manufacturer is not familiar with vns and the patient so she was unable to provide any additional information. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
It was reported from the patient's mother that she is looking for a surgeon to explant the device because he never received benefit from the therapy. No additional relevant information has been received to date and no surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301015
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dennis100
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« Reply #879 on: September 15, 2018, 02:02:58 AM »

Model Number 102
Event Date 01/08/2008
Event Type  Death   
Event Description
Reporter indicated that a vns pt passed away. It was indicated that the pt died while hospitalized for ards. Good faith attempts for add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008926
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dennis100
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« Reply #880 on: September 21, 2018, 01:56:00 PM »

Model Number 304-20
Event Date 10/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Date: settings [output current (ma)/ frequency (hz)/ pulse width (microseconds)/ on time (seconds)/ off time (minutes)/ magnet output current (ma)/ magnet pulse width (microseconds)/ magnet on time (seconds)]; diagnostics: [(normal mode) output status/ lead impedance; (system mode) output status/ lead impedance/ impedance value/ end of service?] : (b)(6) 2012: 0. 5/30/500/30/5; 0. 75/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2012: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/3200ohms/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2762ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2712ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2887ohms/no; (b)(6) 2013: 1. 0/25/500/21/1. 9; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2867ohms/no.
 
Event Description
It was reported that the patient was diagnosed with vocal cord problem that the ent attributes to vns therapy. It was reported that the patient experiences some difficulty breathing as a result of the vocal cord problem. Clinic notes dated (b)(6) 2013, note that the ent confirmed that vns discharges appear to be affecting the left vocal cord function, which may be compromising respiration in the context of his right-sided cyst. It was reported that device diagnostics were within normal limits. The physician may try to adjust device settings and then send the patient back to ent for reevaluation. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3418880
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dennis100
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« Reply #881 on: October 04, 2018, 04:20:50 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was initially reported that the patient had the generator explanted due to not having seizures anymore. It was later received that the patient had the device removed due to throat irritation which did not allow her to sing. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
It was reported via clinic notes that the patient's explant was also done due to problems breathing and talking for the patient. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7110827
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dennis100
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« Reply #882 on: October 06, 2018, 06:12:57 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/15/2018
Event Type  Injury   
Event Description
A patient's father reported that a patient was hospitalized for several days due to dizziness and breathing difficulties. The patient's father was not sure whether these events were related to vns, which he reported had been turned off several years prior. Per an mri tech, a physician confirmed that the device was off; however, a physician's assessment regarding these events has not bee received to date. Programming history was reviewed and confirmed that the patient's device was programmed off. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7870359
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dennis100
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« Reply #883 on: October 14, 2018, 12:44:34 PM »

Model Number 103
Event Date 08/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, the patient reported that she was experiencing a change in seizure pattern in which she was having new seizure types and nocturnal seizures. It is unknown what the relationship of the change in seizure pattern is to vns therapy. In addition, it was reported that the patient went to the hospital the month prior due to concern about her neck bulging with stimulation. The emergency room physician ordered a ct scan of the neck. Per the patient, the emergency room physician stated that it appears the lead is 'on the main vein. ' the patient was instructed to temporarily stop stimulation using the magnet and see the primary vns physician with ct scan results. Per the patient, the vns physician disabled the device and stated that he thought the device was on high settings. The physician recommended the patient follow up with her surgeon; however, the patient does not have the resources to do so at this time. In addition, the patient has also reported experiencing a pain in the neck area, extreme voice hoarseness with stimulation, painful stimulation, difficulty breathing with stimulation, and loss of gross mobility with much of stimulation. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2887104
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dennis100
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« Reply #884 on: October 27, 2018, 01:16:34 AM »

Model Number 102
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was reported by the patient's mother that the vns patient was previously intubated during an unknown procedure. During the intubation, vns stimulation was left on which reportedly resulted in irritation and swelling the vocal cords. The swelling was so severe that when the intubation tube was removed, the patient couldn't breathe and had to be re-intubated and placed on a ventilator. The vns stimulation was then turned off and the swelling reportedly started going down. After three days the patient was taken of the ventilator and was "fine. " the patient's vns was programmed back on. Follow-up with the vns implanting surgeon found no record of any surgery at the reported time was noted. Diagnostics taken on (b)(6) 2010, were within normal limits. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the initial report inadvertently did not report that the explanted generator was previously received by the manufacturer. Device evaluated by mfr, corrected data: the initial report inadvertently did not report that the explanted generator was previously evaluated by the manufacturer.
 
Event Description
The patient's generator was replaced due to normal end of service on (b)(6) 2010. The pulse generator was returned for analysis to the manufacturer, and the module performed according to functional specifications during product analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Additional information was received from the treating cpnp indicating that she does not have access to the records regarding when this event occurred. She suspected sometime in (b)(6) 2011. Since the timeframe is unclear, the event date will be left as 2010. She attributes the vocal cord swelling to intubation and the continued vns stimulation. The only intervention that was reported was the device being temporarily turned off at the time of the event. Prior to the onset of the swelling, the patient was ill with acute viral respiratory illness. The patient does not have a history of similar issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2786736
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dennis100
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« Reply #885 on: October 29, 2018, 11:16:41 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Event Description
On (b)(6) 2012, a vns patient's son reported that the vns patient had recently passed away. The son reported that the death was not related to vns. An online obituary search showed that the patient's date of death was (b)(6) 2012. On (b)(6) 2012, follow up with the funeral home and physician's office was performed. Follow up with the associated funeral home revealed that the device was explanted prior to burial and discarded. It was also stated that the cause of death was cardio-respiratory failure. The physician's office stated that the patient had not been seen for some time. A battery life calculation was performed on (b)(6) 2012 with 9. 18 years to eri=yes. Attempts for additional information have been unsuccessful.
 
Event Description
This death event has been evaluated and with the available information the death has been determined to be possible sudep. Even though the funeral home reported the cause of death was cardiorespiratory failure, this is very vague and ultimately all deaths occur as a result of cardiorespiratory failure in some manner. The circumstances of the death, the general health of the patient, location of the death (inpatient or at home), and if seizures were involved with the death are all still unknown. As such, sudep cannot be ruled out as a possible cause of death.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, the patient's death certificate was received. The certificate indicated that the patient passed in a natural manner. The underlying cause was cardiorespiratory failure (few days), septic shock with multi-system organ failure, and chronic liver disease with (b)(6). Follow-up with the patient's physician showed that no information was available regarding the patient. A sudep evaluation was performed with the new information. This death event has been reviewed and with the available information has been determined not to be sudep. Per the death certificate, the cause of death was cardiorespiratory failure, septic shock with multi-organ failure, and chronic liver disease with (b)(6). Although the location of the death is not listed on the death certificate, it is likely the patient died in a hospital setting due to the reported event of septic shock and multi-organ failure. The patient was likely in a poor state of health at the time of death, and the death was likely witnessed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2672168
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dennis100
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« Reply #886 on: October 30, 2018, 01:00:12 AM »

Model Number 300-20
Event Date 01/01/2012
Event Type  Injury   
Event Description
Additional information was received, in the form of an ent evaluation, on (b)(6) 2012. The ent noted that the patient presented with respiratory insufficiency and hoarseness, but described the symptoms as mild. It was noted that the left vocal cord was immobile. Additionally it was noted that there was a questionable growth in the area of the voicebox. The patient was referred for a direct laryngoscopy esophagoscopy and biopsies. Attempts for additional information from the ent physician have been unsuccessful to date.
 
Manufacturer Narrative
Additional information was received which corrects the date of event. This report is being submitted to correct this information. Additional information was received which corrects the date of event. This report is being submitted to correct this information.
 
Event Description
Additional information was received from the ent. It was indicated that it was unclear if there was an actual growth on the voice box, however he stated that if there was, it was likely not related to vns. The ent stated that it was possible that the paralysis was related to vns, but indicated that it was unclear if the paralysis was occurring with stimulation on times, if there had been any manipulation or trauma, or if there were any programming or medication changes which preceded the events. The ent noted that the patient had not returned for follow up care, and the he was unaware of any prior history for this patient.
 
Manufacturer Narrative
 
Event Description
It was reported by the physician on (b)(6) 2012 that the patient had developed vocal cord paralysis in (b)(6) 2012. The patient was last seen in (b)(6) and diagnostics at that time were within normal limits with an impedance value of 2571ohms. The patient saw another physician who indicated that the patient had left vocal cord paralysis. The physician feels that the paralysis is related to vns. No trauma or manipulation to device was reported and there had been no change in the patient's settings. The generator was left on. The patient had also experienced idiopathic right vocal cord paralysis. He had a tracheostomy and the airway is protected. The patient was being seen again by the physician where he planned to re-perform diagnostics. Additional follow up was performed with the physician. It was indicated that the physician could not explain how after years of safe and tolerated stimulation, this patient would suddenly develop dual vocal cord paralysis, but stated that vns must be the cause. The patient also developed pneumonia in (b)(6) and saw an ent for the vocal cord issue. The paralysis was not occurring with stimulation and he had no history of vocal cord paralysis prior to implant. The diagnostics which were performed were again within normal limits and the physician decreased the duty cycle and lowered the patient's output current. Results of the ent evaluation were pending.
 
Event Description
It was reported that the patient's vocal cord paralysis may have been caused by the patient's pneumonia that developed in (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2772553
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dennis100
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« Reply #887 on: November 05, 2018, 11:33:47 AM »

Model Number 102
Event Date 07/11/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A company representative in (b)(4) was contacted by a vns treating physician and it was reported that a patient's vns pulse generator could not be interrogated. The generator could not be turned off, as it could not be interrogated, so the magnet was secured onto the area of the patient's chest where the generator was. It was also reported through the company representative that the patient was experiencing apnea. Further information was received from a neurologist stating that vns was related to the patient's apnea and that the apnea episodes occurred with the generator pulses. The product information was unknown to the neurologist because the generator could not be interrogated. It was planned to remove the generator on (b)(6) 2012. Troubleshooting was performed by testing the programming wand's 9v battery, but a fresh 9v battery was not tested; different wands and handheld computers were tested and the interrogation of the reported generator was not successful. The generator was interrogated in different locations; the handheld computer was not connected to an outlet during interrogation; other patients' generators could be interrogated with the physician's programming system therefore, ruling out an issue with their programming system. No causal or contributory programming or medication changes preceded the onset of the apnea; the patient has no medical history of apnea before implanting vns. Good faith attempts are underway to see if the explanted generator can be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2682924
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dennis100
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« Reply #888 on: November 06, 2018, 07:49:45 AM »

Event Date 01/01/2006
Event Type  Malfunction   
Event Description
On (b)(4), 2012 it was reported that the vns patient was initially implanted with vns in the (b)(4) 2002 and began to feel ill with significantly more seizures and absence seizures in 2006. The patient's condition also worsened and he began to cough often and long and coughed until he threw up. The patient was reported to have seen the neurologist on several occasions. In (b)(4) 2009, the patient visited the dentist and the patient's teeth were ground and an ultrasound was performed. The patient 'jumped in the chest' and was hurt by the vns. It was noted that this was pain at the generator site. The patient had severe coughing, felt sick, and had trouble breathing when he left the dentist's office. When the patient came home, the patient's mother suspected that something was not right with the vns. When the settings of the vns could be adjusted by the hospital, the patient coughed hard and long, lost her breath, and turned blue in the face. It was reported that the physician had not been through something like this before. It was noted that this event occurred three times. In the (b)(4) 2010 it was reported that the manufacturer concluded that the vns was broken in the patient's body and the patient underwent revision surgery for a new vns to be implanted. It was reported that the explanted product had been previously been returned for product analysis however as the product information was not provided nor was additional patient identifying information, this could not be verified. Additional information has been requested from the physician but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854670
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dennis100
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« Reply #889 on: November 09, 2018, 03:13:38 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/10/2018
Event Type  Injury   
Event Description
It was reported by a patient that they had their vns removed 2 years after put in because it stopped working and started giving her breathing problems. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7934206
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dennis100
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« Reply #890 on: November 09, 2018, 03:14:16 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/05/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing difficulty breathing, wheezing, and throat tightness for which the vns was disabled. The patient was referred to an ent doctor, and it was determined that the patient was experiencing vocal cord paresis that occurred with vns stimulation. There was no reported medical intervention being taken for the events. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8021844
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dennis100
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« Reply #891 on: November 09, 2018, 03:14:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced apnea after a replacement when the newly implanted generator's settings were programmed to the settings on the previous generator. When this occurred, the patient started having apnea where she would stop breathing for 30 seconds at a time (same as on time). Once the patient's device was off and no longer providing stimulation she was able to breath like normal. This occurred while the patient was still in the operating room. The generator was then programmed off. The patient had no history of apnea. The patient later had the generator turned back on and titrated to lower settings. The patient has had no apnea since the return of stimulation. Per the physician, a combination of vns stimulation and anesthesia contributed to the apnea. The patient reportedly only had apnea at 3ma output current. After the cessation of anesthesia and turning the generator off, they were able to titrate the patient back to the lower settings without issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7981071
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dennis100
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« Reply #892 on: November 10, 2018, 04:19:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2016
Event Type  Injury   
Event Description
It was reported by the patient through social media that she was experiencing voice alteration, breathing difficulties, and pain in the chest and ear. She stated that she wanted to have her device explanted. The explant surgery occurred. The reason for the explant was stated to be due to lack of efficacy and voice alteration. Programming history was reviewed and indicated that the device was functioning as intended, within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7974765
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dennis100
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« Reply #893 on: November 25, 2018, 06:21:55 AM »

Model Number 104
Event Date 01/24/2013
Event Type  Malfunction   
Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. The physician reported that the increase in seizures were below the patient's pre-vns baseline frequency. It was reported that the patient was hospitalized in the icu due to respiratory problems at the time of the increase in seizures. The physician did not feel that vns played a role in the increased seizures. Attempts to have the device returned for analysis have been unsuccessful to date.

Event Description
The explanted generator was returned to the manufacturer. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 690 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows an ifi condition. The data in the diagaccum consumed memory locations revealed that 107. 632% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. However, a review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy. This error results in an incorrect device longevity estimate. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3109902
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dennis100
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« Reply #894 on: November 29, 2018, 03:15:48 AM »

Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction   
Event Description
On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".

Event Description
On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.

Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided to date. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.

Event Description
On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.

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

Event Description
On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.

Manufacturer Narrative
Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167236
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« Reply #895 on: December 07, 2018, 11:02:19 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized due to an increase in seizures and that the patient had stopped breathing at one point. It was suspected that the vns battery was low or completely depleted. The patient's generator was later replaced due to battery depletion. Device return is not expected as the explanting facility does not return devices per the facility's policies. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8104605
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dennis100
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« Reply #896 on: December 07, 2018, 11:03:04 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported that the patient underwent a full vns explantation surgery. It was noted that the patient was "a picker. " follow up with the patient's neurologist revealed that the patient was explanted due to a post-operative hematoma that compromised the patient's respiratory airway. A review of device history records revealed that both the lead and generator were sterilized prior to distribution. The explanted products were received by the manufacturer and are pending product analysis. The explant data form received with the products indicated that a dehiscence wound was present at the generator site. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8081287
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« Reply #897 on: December 13, 2018, 04:45:36 AM »

Model Number 103
Event Date 07/23/2013
Event Type  Death   
Event Description
It was reported that the vns patient died the month prior. No other information was provided. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Date received by manufacturer; corrected data: this date on follow-up mfr. Report #01 was inadvertently reported incorrectly. The date should have been 09/15/2014 rather than 09/16/2014. The report was submitted within the 30 day deadline with the date change.

Event Description
Additional information was received stating that the patient¿s immediate cause of death was ventricular fibrillation arrest and aspiration pneumonia with a contributory condition of dvt¿s (deep venous thrombi). No autopsy was performed. The patient¿s body was cremated and the device was not explanted prior to cremation. Approximately one month prior to the patient¿s death, the patient went to the er on (b)(6) 2013 due to increased lethargy and being unaroused. The patient improved during his work-up at the er, and it was the medical opinion that he was ¿most likely suffering from a postictal state that is recovering slowly. ¿ he was not admitted to the hospital and was released to return to his home with continuation of his baseline medications. The clinical impression was ¿altered mental status ¿ resolved¿. On (b)(6) 2013, the patient developed a high fever at the group home facility, seemed lethargic to caregivers, and was having a lot of coughing. The patient was experiencing respiratory failure with low oxygen saturation, a urinary tract infection, and evidence of pneumonia on a ct scan. He was given antibiotics based on his high risk for aspiration due to swallowing difficulty. An endotracheal tube was placed to facilitate oxygenation that markedly improved. The patient was admitted to the icu on mechanical ventilation and was in critical condition at the time of admission. Medical records of the hospitalization indicate that the patient was admitted with fever and subsequently diagnosed with pneumonia (aspiration related). The patient required intubation, he self-extubated , and was then re-intubated. It was decided by a caregiver to avoid extraordinary procedures and to offer comfort only support and he died a few days later due to sudden ventricular fibrillation and cardiac arrest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3342878
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dennis100
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« Reply #898 on: December 18, 2018, 01:11:56 PM »

Model Number 103
Event Date 10/01/2012
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
The supplemental report #1 inadvertently reported that the patient was being seen for explant. The patient was not being seen for explant.

Event Description
Clinic notes were received which indicate the patient experienced aspiration and vocal cord paralysis. Notes dated (b)(6) 2012 indicate the patient has a history of a breathing problem, for which the patient is seeing pulmonology. She also episodes of aspiration for which she is see an ear nose throat doctor. Neck ct scan taken on (b)(6) 2012 reported mild asymmetry of the vocal cord, likely due to the known vocal cord paralysis. Notes dated (b)(6) 2013 report that the patient's mother states the patient is going for a throat issue to fix her aspiration. Per the notes, the patient was going to have a surgical procedure to fix her vocal cord and her aspiration. The patient's vns device would likely get turned off for the surgery and be turned on again afterwards. Follow up with the physician found that aspiration is not related to the vns. The vocal cord paralysis has abated, but was diagnosed before the physician saw her. The vns diagnostics indicate the battery is at ifi = no.

Event Description
The patient was not being seen for possible explant as reported on supplemental report #1. Patient had generator replacement as captured in mfg report #: 1644487-2013-03080.

Event Description
Follow up with the physician found that the patient was diagnosed with the issue prior to seeing this physician and therefore no other information is available. The patient was being seen for possible explant. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3397096
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dennis100
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« Reply #899 on: January 03, 2019, 09:04:11 AM »

Model Number 103
Event Date 06/06/2013
Event Type  Injury   
Event Description
It was initially reported that the patient¿s oxygen saturation decrease during sleep to 83-84%. The casual relationship between vns stimulation unknown. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative

Event Description
Additional information was received that the relationship of the oxygen saturation drop at night to vns is unknown. The physician coordinated a dosage of risperdal and potassium bromide on (b)(6) 2013. During follow-up, the oxygen saturation was 90%. The patient does have a history of asthma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3637222
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