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Author Topic: Pulmonary Embolism  (Read 5684 times)
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dennis100
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« on: July 25, 2012, 07:11:53 PM »

Model Number 102
Event Date 01/01/2007
Event Type  Injury  
Patient Outcome  Hospitalization,Life Threatening
Event Description
Reporter indicated that a vns pt experienced swelling, hardness, and a pulmonary embolism post-implantation. Stimulation was programmed off and the pt was admitted to the icu. Good faith attempts for add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=976231
« Last Edit: January 07, 2016, 06:44:25 AM by dennis100 » Logged
dennis100
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« Reply #1 on: October 03, 2013, 11:04:46 PM »

Model Number 102
Event Date 12/01/2012
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Clinic notes dated (b)(4) 2013 indicated that this patient was having 2-3 seizures per month (but up to 4 in a month) but could go 3-4 months without a seizure. Seizures occurred when the patient was stressed or upset. , the patient had seizures a few months ago due to her daughter¿s wedding. The notes indicated that the magnet did not appear to be helpful for 8 months. It was normally useful in aborting seizures. The device was last interrogated by this physician in (b)(6) 2010 when the patient was last seen. The patient had a previous procedure for a pulmonary embolism. The patient had events of deep vein thrombosis. The patient magnet and vns were not functioning 8 months. The recent worsening was likely due in part o the ns no longer functioning with the patient feels began 8 months prior. Notes dated (b)(6) 2010 indicated that the patient denied any suicidal thoughts but still had some bouts of depression, and settings were provided. Surgery is likely but has not taken place. A battery life calculation shows 0. 13 years remaining.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3373843
« Last Edit: January 07, 2016, 06:44:50 AM by dennis100 » Logged
dennis100
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« Reply #2 on: January 07, 2016, 06:53:37 AM »

Model Number 102
Event Date 07/29/2012
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(4) 2012 indicated that this vns patient was diagnosed with a pulmonary embolism and pneumonia on (b)(6) 2012. The patient's device was interrogated on (b)(6) 2012 and found to be operating nominally and was not at end of service. (the patient had a seizure on (b)(6) 2012 that resulted in her going to hd. ) settings from (b)(6) 2012 were provided. A review of systems was positive for chest pain and irregular heartbeat/palpitations; however, the status of the patient's cardiovascular system indicated regular rate and rhythm and no murmurs, gallops, or rubs. Notes dated (b)(4) 2012 were provided. Notes on both dates indicated that the status of the patient's cardiovascular system indicated regular rate and rhythm and no murmurs, gallops, or rubs. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995749
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dennis100
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« Reply #3 on: March 03, 2016, 04:08:26 AM »

Model Number 104
Event Date 07/27/2011
Event Type Death
Event Description
Reporter indicated a vns pt had died due to an unk reason. The pt had gone to the dentist and returned to her rehabilitation home. The staff found the pt ten minutes after his return lying on the floor. Defibrillation was considered but not performed peer the physician at the scene. The pt does have a history of pulmonary embolisms, but it is known if this was a factor in the death. It is unk if an autopsy was performed. Attempts for further info and the death certificate are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2234228
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dennis100
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« Reply #4 on: March 11, 2016, 02:35:21 AM »

Model Number 102
Event Date 02/10/2009
Event Type Death
Event Description
On (b)(6) 2011, it was reported by a vns treating nurse that the vns pt had died on (b)(6) 2009 due to pulmonary embolism. The relationship of the death to vns is unk. Since cause of death is known, it is not sudden unexplained death in epilepsy. Add'l info regarding the pt's death has been requested from the nurse, however, no further info has been received to date. If add'l info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2103898
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dennis100
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« Reply #5 on: April 01, 2016, 02:25:27 AM »

Model Number 103
Event Date 10/01/2009
Event Type Injury
Event Description
Reporter indicated a vns therapy patient had trouble breathing post initial implant surgery, but prior to device stimulation was activated. The patient went to the e. R. , and was diagnosed with pulmonary embolism. The treating physician stated the event was not related to vns, as every surgery has a chance for a patient to have a pulmonary embolism. The patient is on coumadin now, and vns stimulation has not been activated to date. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1530569
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dennis100
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« Reply #6 on: August 19, 2016, 04:57:39 AM »

Event Date 12/28/2007
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that patient was implanted with the vns therapy device and was turned on by the surgeon at time of implant. Patient experienced vomiting post implant and was seen in the er the next day and was subsequently admitted to the hospital. Additional information received indicated that the patient was diagnosed with a pulmonary emboli and was found to have "low blood oxygen. " the devices was turned off. Implanting surgeon stated that the vomiting was due to the "patient taking pain medication on an empty stomach and not directly related to vns therapy. " good faith attempts are being made to obtain additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=984086
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dennis100
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« Reply #7 on: February 15, 2017, 03:00:13 AM »

Model Number 103
Event Date 12/01/2010
Event Type Injury
Event Description
It was reported on (b)(6) 2012 that an implanted patient was experiencing coughing associated with stimulation once the device was turned on, which resulted in the patient having a pneumothorax 4-5 times; however, the reporter also stated that the patient "had some additional pneumothorax events after the device was turned off, so they appear to not be related to stimulation. " the patient has a history of lymphangioleiomyomatosis (lam) and tuberous sclerosis. The patient expressed wanting the device explanted; therefore, surgery is likely but has not been scheduled to date. Good faith attempts to obtain additional information have been unsuccessful.

Event Description
Additional information was received indicating that given the patient's genetic condition, (b)(6), the patient could experience pulmonary events. If the patient were to cough a couple of times in succession, she could experience a pulmonary embolism. It is believed that the coughing the patient experienced with device stimulation did contribute to the patient having pneumothorax. The physician did not have any additional information to provide.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2488590
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dennis100
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« Reply #8 on: October 28, 2017, 03:03:13 AM »

Model Number 101
Event Date 10/07/2003
Event Type Injury
Manufacturer Narrative
New information corrects the date of event and date of explant reported in initial mfr. Report.

Event Description
It was reported that the patient was hospitalized on (b)(6) 2003. The patient underwent generator explant on (b)(6) 2003 and the patient was discharge from the hospital on (b)(6) 2003. The patient had been hospitalized for systemic sepsis and had a multitude of comorbidities including lung inflammation, pulmonary embolism, boils, acute respiratory failure, heart infection and renal failure. It was reported that the patient was in prison when the patient contracted the illness and the nurse attributed the cause of the sepsis and resulting comorbidities to the unclean prison environment. There was no known trauma or manipulation. The nurse did not believe that vns was related to the infection. The device was explanted prophylactically. The physician believed that having the generator explanted would improve the patient's ability to heal.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Initially, it was reported that the patient was scheduled for vns replacement surgery. The reason was not provided. It was later reported that the patient underwent a vns system implant because the device had been removed previously due to a (b)(6) infection. Further follow-up revealed that the patient underwent explant in 2004 due to the infection. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3676801
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dennis100
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« Reply #9 on: November 01, 2017, 01:29:22 AM »

Model Number 102
Event Date 05/06/2014
Event Type Death
Event Description
Additional information was received stating that the vns patient passed away from pulmonary hemorrhage probably from pulmonary embolism. The patient¿s parent stated that the patient did not look ok following implant surgery; however, the patient was cleared by the surgeon and anesthesiologist. The patient¿s device was never programmed on. An internal evaluation of the available information determined that the death was unlikely sudep.

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

Event Description
It was reported that the patient passed away the day following initial vns implant. The patient's mother reported that an autopsy was planned and that she did not know if the death was a complication of surgery, stroke, embolism, heart attack, etc. The surgeon indicated that he was "not able" to provide system diagnostics from the implant procedure to confirm device function at the time of implant. The patient was not receiving vns therapy at the time of death. Neither generator or lead were explanted after the patient's death. The believed cause of death was reported to be sudep. The surgeon indicated that the relationship between the vns and death was unknown. The surgeon indicated that an autopsy was not performed and that the patient was found unresponsive by the family. The patient had no history of drug or alcohol abuse and no history of cardiac or respiratory problems. The patient was compliant with antiepileptic medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3853786
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dennis100
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« Reply #10 on: January 04, 2018, 02:25:59 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/18/2016
Event Type Death
Event Description
It was reported that the patient had passed away, as confirmed through an online obituary. She was found unresponsive by the nursing staff at her care facility after a possible seizure. Cpr was attempted, but the patient had expired. The patient was previously in the hospital the week before her passing for blood clots, and was transferred to a skilled nursing facility after being in the hospital for a few days. The device history records of the lead and generator were reviewed and found that all specifications were met prior to distribution. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep. No additional pertinent information has been received to date.

Manufacturer Narrative

Event Description
The county coroner showed that the patient¿s death was reported to them, but they did not handle the patient¿s case and had no autopsy report on it. Communications with the office of the treating physician showed that the patient¿s family was requesting an autopsy. The office confirmed that no warnings for abnormal impedance were seen in the last office visit. The patient¿s treating rehabilitation center reported that in the days preceding her death, the patient was diagnosed with dilantin toxicity. The patient then had a seizure and was also found to be very hypoxic. Computed tomography angiography (cta) showed many pulmonary embolisms. The patient was started on a lovenox/coumadin bridge, and her dilantin dose was decreased. Once patient was medically stable, she was transferred to the rehabilitation center. The next day, the patient had a witnessed seizure and appeared to be stable following the seizure. Approximately one hour later, the patient was found pulseless in her room. She was rushed to the hospital and had cpr performed without success. The patient was pronounced dead by the hospital emergency department. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6252764
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dennis100
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« Reply #11 on: January 08, 2018, 03:01:05 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/01/2013
Event Type Death
Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient was found to be deceased after an online obituary search. Follow-up to the physician by a company representative provided the treating physician was unaware of the patient¿s death and had not seen her in years and didn't have any further information. The state will not release the death certificate to the manufacturer. Additional relevant information has not been received to-date.

Event Description
Follow-up to the funeral home where services were performed provided the complicating factors and cause of death as: acute respiratory failure, (onset of 1 day), acute pulmonary emboli, (onset 1 day), acute deep venous thrombosis, (onset 2 months). Direct cause of death was, left leg cellulitis, skin necrosis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309339
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dennis100
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« Reply #12 on: January 11, 2018, 02:31:59 AM »

Model Number 103
Event Date 05/01/2009
Event Type Injury
Event Description
It was reported that the patient has recently had apneic spells lasting a few seconds each. One woke him up out of sleep and others occurred while he was awake. Patient has history of pulmonary embolisms, but lungs are currently clear. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1397395
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dennis100
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« Reply #13 on: January 31, 2018, 01:59:32 AM »

Model Number 102
Event Date 06/03/2010
Event Type Death
Event Description
It was reported by a psychiatrist that a vns pt suffering from depression passed away on (b)(6) 2010. Good faith attempts to obtain more info regarding the relationship of pt's death to vns from the treating physician have been unsuccessful to date. Death certificate was obtained from the corresponding county and the manner of her death was ruled 'natural. ' it also stated that no autopsy was performed on the pt and pt's cause of death was cardiac arrest / sudden death, pulmonary embolism, and asthma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2007261
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dennis100
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« Reply #14 on: February 02, 2018, 03:09:34 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/18/2016
Event Type Death
Event Description
It was reported that the patient had passed away, as confirmed through an online obituary. She was found unresponsive by the nursing staff at her care facility after a possible seizure. Cpr was attempted, but the patient had expired. The patient was previously in the hospital the week before her passing for blood clots, and was transferred to a skilled nursing facility after being in the hospital for a few days. The device history records of the lead and generator were reviewed and found that all specifications were met prior to distribution. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep. No additional pertinent information has been received to date.

Manufacturer Narrative

Event Description
The county coroner showed that the patient¿s death was reported to them, but they did not handle the patient¿s case and had no autopsy report on it. Communications with the office of the treating physician showed that the patient¿s family was requesting an autopsy. The office confirmed that no warnings for abnormal impedance were seen in the last office visit. The patient¿s treating rehabilitation center reported that in the days preceding her death, the patient was diagnosed with dilantin toxicity. The patient then had a seizure and was also found to be very hypoxic. Computed tomography angiography (cta) showed many pulmonary embolisms. The patient was started on a lovenox/coumadin bridge, and her dilantin dose was decreased. Once patient was medically stable, she was transferred to the rehabilitation center. The next day, the patient had a witnessed seizure and appeared to be stable following the seizure. Approximately one hour later, the patient was found pulseless in her room. She was rushed to the hospital and had cpr performed without success. The patient was pronounced dead by the hospital emergency department. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252764
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dennis100
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« Reply #15 on: February 21, 2018, 02:30:07 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 10/18/2011
Event Type Death
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2011 and the patient's cause of death was phlebitis and thrombophlebitis of other deep vessels of lower extremities with epilepsy, unspecified, pulmonary embolism without mention of acute or pulmonale, immobility, and other and unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.

Event Description
Information regarding medications and vns settings from the last office visit on (b)(6) 2010 were provided by the reporter. The patient was taking zonegran, gabapentin, calcium, a multivitamin, and carbatrol medications. The last vns settings were 1. 25ma/20hz/130 pulsewidth/30sec on/5 min off/1. 25ma magnet/30 sec on. The death certificate was received to the manufacturer. The cause of death per the autopsy is listed as: "a deep venous thrombosis with pulmonary thromboembolism (hours) due to probable prolonged immobility following seizure (unknown) due to c. Epilepsy (unknown). " follow up with funeral home revealed the patient's vns was explanted before cremation and discarded.

Event Description
Reporter indicated that a vns patient had died, but no other information was provided. Attempts for further information and disposition of the vns device are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2426109
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dennis100
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« Reply #16 on: May 28, 2018, 01:51:50 AM »

Event Date 06/30/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had presented acute vocal cord paralysis and shortness of breath. The patient was examined by an otolaryngologist and was referred for computerized tomography. It was reported that the events were suspected to be secondary to vns. The patient had had myocardial infarction previously. It was reported that the patient¿s generator was programmed at reduced pulse width and signal frequency, with an output current of 1. 25ma and a 44% duty cycle since 2011. It was reported that the patient was a good responder to vns therapy. Further information was received indicating that the vocal cord paralysis had debuted on (b)(6) 2015. There had been no changes in medication and the patient¿s settings had remained unchanged for a number of years. The patient does not have a previous history of vocal cord paralysis. It was reported that the medical professionals suspected that the myocardial infarction might have led to pulmonary embolism which, in turn, might have contributed to the event, and that a role of vns on the paralysis was believed to be unlikely. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4934372
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« Reply #17 on: September 21, 2018, 01:57:49 PM »

Model Number 304-20
Event Date 07/10/2015
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported on (b)(6) 2015 from the patient that after his vns implantation surgery on (b)(6) 2015 he ended up with a blood clot on his neck at the surgical site. He was on blood thinners after surgery so they stopped those and he started back on warfarin. Follow-up with the neurologist showed that the patient does have a medical history of pulmonary embolism events. No interventions have been taken for the blood clot but the issue is not yet completely resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024811
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