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Author Topic: Deep Vein Thrombosis  (Read 827 times)
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dennis100
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« on: June 22, 2018, 01:54:14 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/01/2013
Event Type  Death   
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 #1 on: June 22, 2018, 01:54:54 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 #2 on: June 22, 2018, 01:55:30 AM »

Model Number 102
Event Date 07/18/2008
Event Type  Injury   
Event Description
It was reported that the vns pt was hospitalized due to pain in right lower extremity and bumps in the right forearm. The pt was diagnosed with deep vein thrombosis at the level of the popliteal vein and thrombus in the greater saphenous vein. The right upper extremity showed some non-occlusive thrombus in the right cephalic vein. Further follow-up revealed that the pt has a history of thrombosis post surgically, therefore it has been determined by the physician that the event is a result of the implantation procedure, and the event is not related to the vns device.
 
Manufacturer Narrative
Implantation procedure caused event, no device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1147204
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dennis100
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« Reply #3 on: June 22, 2018, 01:56:11 AM »

Model Number 103
Event Date 12/20/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient has been referred for generator revision surgery due to the device being "flipped" and migrated. The patient suffered trauma to the area and the device has moved. Clinic notes dated (b)(6) 2013 were received which indicated that after the patient was implanted with the vns in (b)(6) 2012, the patient was subsequently hospitalized with dvt (deep vein thrombosis) for which he was hospitalized and is on coumadin. The patient reported that his daughter grabbed his shirt and grabbed the vns which made it stick up on its side. Then the prior evening, for three hours, he worked to change the position of the vns and caused considerable chest pain in the process. The patient came in on (b)(6) 2013 for x-rays, he feels like the device is still functioning well. The physician reviewed the x-rays and stated that it appears that the patient has flipped the device upside down. The physicians stated that apparently he has either torn the suture or the attachment to the fascia working with manipulation of the device the night prior. The physician reported that the wire appears intact and on firm and feels like it is functional. The physician stated that they will re-open the patient and re-anchor the generator. It was stated that no further information would be provided by the physician. The patient was scheduled for surgery on (b)(6) 2013 but it is unknown whether the generator was replaced or if the implanted generator was just sutured back in place.
 
Event Description
Additional information was received on (b)(4) 2013 when it was reported that during surgery, the generator was just re-sutured down and was not replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3043887
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dennis100
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« Reply #4 on: June 22, 2018, 01:56:43 AM »

Model Number 102
Event Date 12/01/2012
Event Type  Injury   
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3373843
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dennis100
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« Reply #5 on: June 22, 2018, 01:57:22 AM »

Model Number 103
Event Date 10/22/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that, since implant, this vns patient was ¿not right, grumpy, acts like what the hell is going on. ¿ the patient was awake for one to three hours each night with restless legs. Clinic notes dated (b)(6) 2013 were received on (b)(4) 2013 indicating that this vns patient had a past medical history of obstructive sleep apnea and hypopnea and was on pap therapy. The patient had also had multiple deep venous thrombi in the left neck, upper chest, and left upper extremity. Device settings were provided. Follow-up with the medical provider showed that no additional information available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3489278
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dennis100
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« Reply #6 on: June 22, 2018, 01:58:03 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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