Pages: [1] 2 3 4  All   Go Down
Print
Author Topic: Aspiration  (Read 26023 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« on: January 04, 2016, 06:52:56 AM »

Event Date 01/24/2008
Event Type Injury
Patient Outcome Other;
Event Description
Reporter indicated that the pt was experiencing aspiration during recovery from vns implant. Follow-up with the physician indicated that aspiration was likely related to the pt recovering from the surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1004531
« Last Edit: January 29, 2016, 05:05:59 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #1 on: January 04, 2016, 06:53:24 AM »

Event Date 05/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that patient experienced an episode of aspiration after implant surgery, but prior to initiating stimulation. Further follow-up revealed that the patient's device has since been programmed to on without incident. The patient is reportedly improving, but the event is not yet resolved. Physician indicated that the event was secondary to surgery and developmental delay and is not directly related to the ncp system.

Manufacturer Narrative
Further follow-up revealed that the patient's device was programmed to off because patient continued to have aspiration problems. The physician attempted to adjust the device parameters in order to alleviate the aspiration; however this was not successful. H. 6. : the ncp system labeling lists aspiration (fluid in the lungs) as a potential adverse event possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=406438
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #2 on: January 04, 2016, 06:53:55 AM »

Event Date 04/13/2005
Event Type Injury
Patient Outcome Disability; Required Intervention.
Event Description
Vns patient developed severe hoarseness four days post-implant. The patient has since been diagnosed with left vocal cord paralysis. Stimulation had not yet been initiated. The patient noticed some hoarseness the day after implant surgery which became worse over the next three days. Since that time, the hoarseness has neither worsened nor improved. At follow-up office visit, one treating physician indicated that the vocal cord paralysis was most likely related to the implant surgery and manipulation during the placement of the lead electrodes. The patient was prescribed decadron in an attempt to affect to swelling in the area. At follow-up visit with implanting surgeon, it was noted that the patient's hoarseness had progressed to aspiration of some liquids and fluids. The decadron reportedly provided no relief. Implanting surgeon indicated that the patient's symptoms are consistent with injury of a recurrent meningeal nerve. Implanting surgeon indicated that during implant surgery, the dissection was deep and with more retraction than is often required due to the patient's neck size and significant limitation and extension. It was reported that the patient has not been able to undergo any formal diagnostic direct or indirect laryngoscopy because they have had seizures during these attempted procedures. The patient is scheduled for a barium swallow and further follow up with an ent physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612665
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #3 on: January 04, 2016, 06:54:18 AM »

Event Date 04/26/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the pt has experienced worsening of aspiration since vns therapy system implant. Further follow-up revealed that the pt has not been feeling well since their third day post-implant and has been producing copious amounts of oral secretions and needs frequent suctioning. The pt's family member indicated that recent suctioning has been difficult because the pt has experienced bloody mucous due to irritation of their oral airway. The pt's family member later reported that the pt is doing better and is no longer requiring supplemental oxygen. The magnet has been taped over the device to temporarily discontinue device stimulation. The pt's family member also reported that prior to surgery, family member was aware of the increased risk of aspiration.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=530604
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #4 on: January 04, 2016, 06:54:39 AM »

Event Date 06/16/2000
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Vns pt with lennox-gastaut syndrome developed an infection immediately after implant due to excessive drooling and the infection worsened, extending into the pt's breast tissue. It was also reported that the pt began having problems with aspiration which led to aspiration pneumonia. The pt reportedly had to eat almost pureed foods during this time and was already very thin. The pt has since had surgery (type known) and no longer has the problem with aspiration. The pt's device has been programmed to off for over two years. Review of manufacturing records for the bipolar lead confirmed sterilization of the device and revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine the cause of the aspiration pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=553342
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #5 on: January 04, 2016, 06:55:02 AM »

Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated that vns pt was being explanted due to aspiration. Investigation to date has been unable to determine a cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=565697
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #6 on: January 04, 2016, 06:55:23 AM »

Event Date 10/13/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
While in picu after initial implant surgery, the pt's oxygen level dropped from 98% to 71% and that a chest x-ray showed that they had aspirated. It was reported that the pt "let out a load yelp" when blood was drawn from the artery in their wrist, which cleared the blockage in their lung. The pt's breating reportedly started returning to normal afterward. The pt was also reportedly bleeding internally during this time, which was believed to be caused by toxic medication levels in combination with either a small scrape by the intubation tube or a posterior nosebleed due to the anesthesia. Investigation to date has been unable to determine the cause of the reported aspiration event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=585253
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7 on: January 04, 2016, 06:55:47 AM »

Event Date 05/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt aspirated and subsequently developed aspiration pneumonia. It was reported that the pt recently coded, requiring use of a defebrillator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=610735
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #8 on: January 04, 2016, 06:56:11 AM »

Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt underwent placement of a feeding tube because of excessive weight loss. It was reported that the pt "couldn't keep anything down". The surgery to place the feeding tube reportedly went well; however, the pt suffered a status seizures shortly afterward and subsequently aspirated. The pt then developed pneumonia in both lungs. Breathing treatments and antibiotic therapy were prescribed. The pt was not comatose, but was reportedly in an "altered level of consciousness" for unk reasons during this time. At this time, it is unk if the reported events are a result of the pt's disease progression or whether they are vns-related. Due to the length of time that the pt has been implanted with the vns therpay system, it is not likely that the events are vns-related. Report is incomplete because attempts to identify the pt's current treating neurologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=646478
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #9 on: January 04, 2016, 06:56:35 AM »

Event Date 05/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Vns patient began coughing approximately one month ago and that the coughing increased to the point that the patient developed bronchitis and subsequent pneumonia. The pneumonia was treated with antibiotics, but eh antibiotics did not help. This lead to chronic aspiration and now the patient is on continuous oxygen due to low oxygen saturation. The patient's device was programmed to off in attempt to allefiate their symptoms. The patient has been instructed to follow-up with neurologist at his office in a couple of weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=619815
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #10 on: January 04, 2016, 06:57:00 AM »

Event Date 08/19/2005
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that vns pt implanted for treatment of depression was diagnosed by an ent with laryngeal palsy which is reportedly being treated with collagen. It was reported that the pt experienced hoarseness around the time of her first programming and was later seen by an ent due to aspiration and difficulty swallowing. Further follow-up revealed that the pt's hoarseness three weeks after a collagen injection into her vocal cords. The pt also indicated that she had some clear liquid aspiration per barium swallow performed one week post-implant, but that this had also improved. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating psychiatrist (via fax x1). Additionally, device tracking information was not forwarded to manufacturer at the time of initial implant and this information was reportedly not contained in the implanting surgeon's records.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642444
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #11 on: January 04, 2016, 06:57:23 AM »

Event Date 01/24/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported via clinic notes that a vns pt was having increase in seizures, voice hoarseness, and aspiration. On (b)(6) 2011, the neurologist referred the pt for generator replacement since it was near end of service. The generator was received by the mfr and currently is undergoing product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2190784
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #12 on: January 04, 2016, 06:57:49 AM »

Event Date 05/03/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient was experiencing an increase in aspiration. The patient was programmed to output=1. 50ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=500usec. A battery life calculation was performed which showed negative years until eri = yes. Additional information has been requested from the physician but no further information has been received to date. When additional information is received, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2243281
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #13 on: January 04, 2016, 06:58:13 AM »

Model Number 302-20
Event Date 08/20/2012
Event Type Injury
Patient Outcome Other,Required Intervention
Event Description
It was reported by the patient's mother on (b)(6) 2012 that her son is in the hospital had it was confirmed that he had left vocal cord paralysis. The patient's mother reported that the patient has been in and out of the hospital for months now due to the problems with the vocal cords and aspiration pneumonia. She reported that the patient had been in and out of the hospital 10 times over the last year for aspiration pneumonia and the physician's finally today said it is left vocal cord paralysis. She states the neurologist turned patient's generator off on (b)(6) 2012. The patient had an aspiration study done the week prior and the patient's mother indicated that the aspiration was bad. The only thing that has changed is they increased one of his medications recently. No additional information is known at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2749205
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #14 on: January 04, 2016, 06:58:39 AM »

Model Number 103
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
Event Description
It was reported that the patient had a mini stroke in (b)(6) and has since been experiencing aspiration and severe dysphagia. The speech pathologist did not know if the events were related to vns. She was planning to use muscle stimulation on the patient¿s throat. Good faith attempts for additional relevant information have been unsuccessful to date.

Event Description
It was reported that the patient was coughing up blood and having difficulty swallowing for approximately the past two months. The patient has changed physicians and when the patient was first seen by the new physician the patient was bradycardic and hypotensive. The patient's brother reported that the patient underwent testing because it was thought the patient had lunch cancer from spitting up blood. No additional relevant information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377461
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #15 on: January 04, 2016, 06:59:07 AM »

Model Number 103
Event Date 10/01/2012
Event Type Injury
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.

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.

Manufacturer Narrative

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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #16 on: January 04, 2016, 06:59:38 AM »

Model Number 105
Device Problem No Information
Event Date 07/18/2013
Event Type Malfunction
Event Description
Additional information was received that the surgeon did a procedure to treat the vocal cord paralysis and not the patient is experiencing an increase in seizures. At this time the surgeon does not know the cause of the increase in seizures. No other information was provided.

Event Description
The patient was to follow-up with orl surgeon. Upon further follow-up with regards to the seizures, the physician did not think the seizures have increased. The patient¿s seizures are noted to be occasional.

Event Description
Clinic notes dated (b)(6) 2015 reported in the history of present illness that since the vns has been placed, the patient has developed some vocal cord problems and was seeing an ent. No vns programming changes were made.

Manufacturer Narrative

Manufacturer Narrative
The supplemental report #3 inadvertently did not report this information from the physician.

Event Description
The physician indicated that the decreased motility of the vocal cord is probably related to vns therapy. The physician was unsure if the decreased motility of the vocal cord occurred with stimulation. The physician reported that the pneumonia has resolved and that the vocal cord paralysis is presumed to persist as her dysphonia has persisted.

Event Description
On (b)(6) 2013, it was reported that since the patient's vns revision surgery, the patient's voice has gone out. There were no further details on what this meant besides that the patient's voice got hoarse and the patient lost her voice temporarily. It was unknown whether this was with stimulation or not. The patient also had pneumonia after the surgery; however, the relationship to vns was unknown. Additional information was received that testing found the patient had some "sleepiness" of the left vocal cord. Per the physician, the pneumonia was likely related to the vocal cord not working as it probably allowed the patient to aspirate, causing the pneumonia. On the one month post-op visit, the physician noted that the wounds had healed nicely at that time. The patient was quite hoarse after surgery. Examination of the vocal cords indicated decreased mobility of the left vocal cord. It was noted that the vocal cord was not paralyzed, but had decreased mobility. The patient was experiencing mild aspiration. The physician gave the patient swallowing tips and recommended potential further action if the event did not improve; however, he was hopeful for resolution as there was some mobility. No additional information has been provided.

Manufacturer Narrative
Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date. Type of reportable event, corrected data: the supplemental report #1 inadvertently did not change the reportability to product problem since the patient is experiencing an increase in seizures with no reported interventions taken to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3322853
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #17 on: January 04, 2016, 07:00:05 AM »

Model Number 105
Event Date 06/26/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2013 information was received from the reporter stating that the vns patient was aspirating liquids along with experiencing hoarseness since implant. It was reported that the patient was recently implanted and that the device had not yet been programmed on. It was reported that no device diagnostic tests have been performed since the device is off. The patient has been referred to neurosurgeon for follow-up. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3257441
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #18 on: January 04, 2016, 07:00:35 AM »

Model Number 102
Event Date 03/15/2013
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Date of event: new information identified when the events started.

Event Description
It was reported that the events resolved on (b)(6) 2013.

Event Description
It was reported that a vns patient since being implanted (b)(6) 2013 presented with drowsiness, with nausea, vomiting, anorexia, aspiration when feeding from the implant. No rhythmicity depending on the frequency of stimulation. The patient therapy has been titrated per their study protocol. The patient had persistence of their symptoms the parents contacted the surgeon, who offered to temporarily stop their therapy to see if there would be improvement and check relationship to their device. Symptoms partially regressed between (b)(6). They disabled their device on (b)(6), and started again with modified settings (b)(6) the 2013. In the meantime, no change in symptoms. Their following physician does not think that the symptoms are related to the stimulation, provided that the patient has since developed a cold sore and fever. Only food-initial aspirations are potentially linked, in their opinion. No change in medication was reported and no medicinal treatments.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3132031
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #19 on: January 04, 2016, 07:01:02 AM »

Model Number 102
Event Date 07/12/2007
Event Type Injury
Event Description
On (b)(6) 2013, the patient's mother reported that the patient had the feeding port removed and "everything" was working functionally. The mother indicated that the patient's device was turned off, the patient's symptoms started to go away, and the patient has improved. Additional attempts were made to the physician for information; however, they were unsuccessful. No additional information has been provided.

Event Description
The patient's mother reported that the patient was doing well. No adverse events were reported. The patient was in the hospital on (b)(6) 2013, but no other information was provided.

Event Description
On (b)(6) 2013 the patient¿s mother reported that since (b)(6) 2013, the patient has had to have his feeding port replaced at the hospital 5 times as he rips them out immediately after having them put in. The patient no longer has a feeding port and is now eating only soft foods and will be having a swallow test.

Event Description
It was reported that the patient's vns was programmed off on (b)(6) 2012. The physician reported that the patient's pulsating neck and voice alteration first occurred in 2006 and that the difficulty swallowing and choking, aspiration, and loss of consciousness began in (b)(6) 2011. It was reported that the patient went into shock and his heart stopped which was a reaction to tp nutrition and not related to vns therapy. It was reported that the loss of consciousness was unrelated to vns therapy and that the loss of motility of the patient's esophagus was unlikely related to vns therapy. The physician reported that the patient's pulsating neck, voice alteration, difficulty swallowing and choking, and aspiration are possibly related to vns therapy. The patient's mother reports that the patient's gi motility has returned to normal. The patient has no history of these events prior to vns therapy.

Event Description
On (b)(6) 2013, the patient¿s mother reported that the vns has caused him to lose the ability of his vagal nerve and also caused his stomach to stop working properly. The patient had to have a feeding port put in. The mother stated that the infrared actually ¿revved up¿ his vns.

Manufacturer Narrative

Event Description
On (b)(6) 2013 when it was reported that the infrared on the wii almost burned out her son¿s vagal nerve and he has lost the ability to use his esophagus and had to have a feeding port put in. The reporter indicated that her son¿s problems began when they got a wii video game system about six years ago. She said that the infrared (ir) on the wii system revved up the vns to the point that it affected his voice and said you could see his neck pulsating. She said this happened every time her son was in the direct path of ir remote or receiver. She says that she did her own test using a board and a pillow - and she used this to block the ir signal. With the board and pillow blocking the ir signal, the patient was fine, but as soon as it was removed, the patient started exhibiting these adverse effects again (voice alteration and pulsating neck). She said that things started to get worse for her son, and in 2011, her son lost the ability to use his esophagus. She said she observed problems with choking and swallowing. She said she became very concerned about this when the patient started choking and aspirating and became unconscious. She says that an ambulance was called, and the patient was taken to the hospital. She said the physician at the hospital did an endoscopy and another test and found out that the patient lost motility of his esophagus and had problems with his stomach emptying. It was also said that the patient had ileus (bowel obstruction). The patient had to get a feeding port put in and during the implantation of the port, whatever they were giving him caused him to go into shock, and his heart stopped. She said the patient "came back" before they had to use the paddles to revive him. The reporter indicated that all these problems and complications boiled down to the vns device, so she had requested that the device be turned off. She said that she asked the physicians at the hospital to turn it off, which she thought they did, but it turns out they didn¿t. Their normal neurologist interrogated the device and saw it was still programmed on; therefore, the neurologist programmed the device off about 6 months ago. The reporter stated that after the device was disabled, the patient has been doing fine, and is even getting some motility in his esophagus back. Good faith attempts for further information from the neurologist have been unsuccessful. It was previously reported in (b)(6) 2011 that the patient was having problems with regurgitation and choking. The problem begins 3-4 hours after the patient is done eating and started a couple of months ago.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3127809
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #20 on: January 04, 2016, 07:01:28 AM »

Model Number 101
Event Date 05/18/2001
Event Type Injury
Event Description
Clinic notes were received for review. It was reported that this patient's device was at end of battery life. Clinic notes dated (b)(6) 2013: "he had a vagus nerve stimulator placed in 2003 or so and developed an upper gi bleed from recurrent retching. Endoscopy has revealed a hiatal hernia. " the relationship of this to their implant is unknown good faith attempts are underway for further details. The patient's father called and reported that the patient aspirated on (b)(6) and was in the icu, intubated, and discharged on (b)(6). The patient has left side weakness as a result of previous epilepsy surgery. The patient's father is an ent physician from another country, and states the aspiration was not caused by their vns but the patient's other co-morbidities. He reported that the patient was unable to tolerate increases in vns dosing over the years, causes "retching", since vns was placed in 2001. He does not believe that patient has received "much benefit" but feels that should have replacement as there are no other options left to him.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075317
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #21 on: January 04, 2016, 07:02:11 AM »

Event Date 07/09/2007
Event Type Death
Patient Outcome Death;
Event Description
It was reported to the mfr that a vns epilepsy pt had passed away. The pt is believed to have died as a result of aspiration of vomitus following a seizure. Attempts to obtain add'l info from the treating physician regarding the event have been made, but have been unsuccessful to date. The last diagnostics tests performed on the pts' device indicate the device was functioning as intended.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=902609
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #22 on: January 04, 2016, 07:02:33 AM »

Event Date 02/08/2008
Event Type Death
Patient Outcome Death;
Event Description
It was reported to manufacturer that the vns patient passed away. The site reported that the patient had aspirated and was taken to the emergency room with decreased oxygen. The patient coded in the emergency room and was subsequently placed on a ventilator. The patient reportedly expired due to aspiration and respiratory distress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1012528
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #23 on: January 04, 2016, 07:02:59 AM »

Event Date 06/22/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that pt passed away due to aspiration. The pt reportedly aspirated in their sleep and was found dead in the morning. The pt was last seen by the physician in 05/02 and was receiving vns therapy at the time of death. No autopsy was performed and the ncp system was not explanted. The pt reportedly had a >50% reduction in seizures with the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=421687
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #24 on: January 04, 2016, 07:03:21 AM »

Event Date 01/05/2003
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the cause of death as complication of chronic aspiration, cerebral palsy and microcephaly. Premature birth was listed as another significant condition contributing to death but not resulting in the underlying cause. The manner of death was listed as natural. Physician indicated that the ncp system was not related to the cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=441705
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #25 on: January 04, 2016, 07:03:44 AM »

Event Date 10/09/2002
Event Type Death
Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evalauted available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate lists immediate cause of death as respiratory insufficiency secondary to pulmonary congestion and edema with aspiration and probable seizure. Autopsy results were considered in determining the cause of death. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=507048
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #26 on: January 04, 2016, 07:04:12 AM »

Event Date 01/06/2005
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt had several seizures, aspirated and then had a heart attack. No autopsy was performed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571493
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #27 on: January 04, 2016, 07:04:34 AM »

Event Date 08/05/2000
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Field report: pt implanted with the vns on 2000. No complications during surgery. However, surgery did take a bit longer than usual due to aberrant anatomy. Post-operatively the pt aspirated. The pt was kept at the hosp overnight for observation and released the following day. The device was not turned on. The facility's medical director concluded the death was related to seizures. Pt death f/u form: physician reports believed relationship between the ncp system and cause of death to be not related. Found unresponsive, resuscitation efforts unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=317944
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #28 on: January 04, 2016, 07:04:58 AM »

Event Date 09/11/2005
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt experienced 2 bad seizures and was subsequently hospitalized approx 1 1/2 weeks post vns implant surgery. Stimulation had not yet been initiated. The pt aspirated while hospitalized and later passed away while hospitalized. The pt was diagnosed with ards (acute respiratory distress syndrome). Treating neurologist indicated that cause of death was aspiration pneumonia secondary to seizure and ards. The device was not explanted prior to burial. Certificate of death lists acute respiratory failure, secondary to acute respiratory distress syndrome, secondary to aspiration pneumonia-bilateral as the cause of death. No autopsy was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=642198
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #29 on: January 04, 2016, 07:05:25 AM »

Event Date 04/09/2011
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the pt had passed away. Per reporter, the pt was hospitalized due to him being in status epilepticus. The hospital then put him in an induced coma to try to control them. While in the induced coma, the pt then aspirated and died. The physician indicated that the status epilepticus was not related to the vns. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2116606
Logged
Pages: [1] 2 3 4  All   Go Up
Print
Jump to: