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dennis100
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« on: May 21, 2018, 01:59:00 AM »

Model Number 102R
Event Date 10/25/2013
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2013. The cause of death was unknown. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.
 
Event Description
Additional information was received stating that the vns patient was in the icu at the time of her death. The patient¿s discharge summary and expiration note were received. The patient was admitted to the hospital for persistent right hip pain following a fall six days prior. It was noted that the patient was a ¿medically complex patient¿. The patient had obvious bruises to her right hip and was unable to bear significant weight on her right leg. She had complained of a dry cough for the past week and was placed on antibiotics, and she was recently diagnosed with acute urinary tract infection (uti). A ct of the head revealed left middle ear cavity and mastoid disease suggesting otomatoiditis, status post right mastoidectomy, but no acute intracranial abnormality. Her chest x-ray revealed increased pulmonary lung markings and her inr in the emergency department was 11. 5 (very high). The patient was subsequently admitted for further treatment. The death summary lists additional final diagnoses as follows: mechanical fall with pelvic rami fractures; severe community-acquired multilobar pneumonia; septic shock; and acute hypoxemic respiratory failure. Following her admission, the patient became increasingly dyspneic and tachypneic with a very pernicious cough and she required increasing levels of supplemental oxygen in the icu. The patient developed hypotension and acute hypoxemic ventilatory failure requiring mechanical ventilation, but failed to respond to positive end expiratory pressure and was placed on bi-level ventilation. On the fifth day of her hospitalization, the patient developed profound refractory hypotension and pulseless electrical activity, followed by ventricular tachycardia and subsequent asystole. The physician who drafted the death summary suspected that the cause of the patient¿s death was ¿myocardial ischemia¿. There was no mention of the patient¿s implanted vns system in any of these hospital records. Based on the available information about the patient¿s death, an internal classification has determined that the death may be unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551654
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dennis100
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« Reply #1 on: May 21, 2018, 01:59:39 AM »

Model Number 102R
Event Date 10/25/2013
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2013. The cause of death was unknown. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.
 
Event Description
Additional information was received stating that the vns patient was in the icu at the time of her death. The patient¿s discharge summary and expiration note were received. The patient was admitted to the hospital for persistent right hip pain following a fall six days prior. It was noted that the patient was a ¿medically complex patient¿. The patient had obvious bruises to her right hip and was unable to bear significant weight on her right leg. She had complained of a dry cough for the past week and was placed on antibiotics, and she was recently diagnosed with acute urinary tract infection (uti). A ct of the head revealed left middle ear cavity and mastoid disease suggesting otomatoiditis, status post right mastoidectomy, but no acute intracranial abnormality. Her chest x-ray revealed increased pulmonary lung markings and her inr in the emergency department was 11. 5 (very high). The patient was subsequently admitted for further treatment. The death summary lists additional final diagnoses as follows: mechanical fall with pelvic rami fractures; severe community-acquired multilobar pneumonia; septic shock; and acute hypoxemic respiratory failure. Following her admission, the patient became increasingly dyspneic and tachypneic with a very pernicious cough and she required increasing levels of supplemental oxygen in the icu. The patient developed hypotension and acute hypoxemic ventilatory failure requiring mechanical ventilation, but failed to respond to positive end expiratory pressure and was placed on bi-level ventilation. On the fifth day of her hospitalization, the patient developed profound refractory hypotension and pulseless electrical activity, followed by ventricular tachycardia and subsequent asystole. The physician who drafted the death summary suspected that the cause of the patient¿s death was ¿myocardial ischemia¿. There was no mention of the patient¿s implanted vns system in any of these hospital records. Based on the available information about the patient¿s death, an internal classification has determined that the death may be unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551654
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dennis100
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« Reply #2 on: May 21, 2018, 02:00:28 AM »

Model Number 103
Event Date 01/31/2012
Event Type  Death   
Event Description
On (b)(6) 2012, correspondence with the user facility's autopsy director revealed that the patient was in status epilepticus, and the generator was implanted as an intervention. It was believed that the death was not related to vns. The autopsy report was provided to the manufacturer. The autopsy report indicated that the patient was healthy until (b)(6) 2012, when she developed high fevers, without other symptoms. On (b)(6) 2012, antibiotics were started for a throat infection but the fevers persisted. On (b)(6) 2012, the patient was lethargic, and during the night, she was found unresponsive with muscle stiffness and her eyes open. The patient was intubated at an emergency department. The patient was transferred to another facility and admitted directly to intensive care. The cerebrospinal fluid had 4 neutrophils/ml and normal numbers of lymphocytes; the glucose was elevated. An mri showed localized edema of the hippocampi and fornical column, probably postictal edema. An extensive infectious disease workup on the blood and csf was negative, looking for bacteria, including bartonella, viral encephalitis viruses, adenovirus, and herpes simplex virus. The acylcarnitine profile, blood amino acid screen and urine organic acids were negative for metabolic disease, and a paraneoplastic work-up was negative. Pulse steroids were given for a possible autoimmune encephalitis. From admission, the patient had persistent seizure activity in spite of multiple antiepileptics. A pentobarbital infusion did not stop seizure activity despite burst suppression; when pentobarbital was stopped because of possible propylene glycol toxicity, a versed infusion was given, also without effect. A series of therapeutic apheresis procedures was started. On (b)(6) 2012, inhaled sevoflurane was started, also without effect on the seizures; epinephrine was required for hypotension and lasix for volume overload. The latter was subsequently replaced by hemofiltration. The vns device was placed on (b)(6) 2012. Despite all measure, status epilepticus continued. An echocardiogram on (b)(6) 2012, showed mildly decreased left ventricular function, and a follow-up on (b)(6) 2012, showed severe right and left ventricular systolic dysfunction and pericardial effusion, which did not respond to treatment with pressors. Care was redirected at the parents' request and death occurred on (b)(6) 2012. Per the autopsy report, significant autopsy findings included global ischemic encephalopathy with astrogliosis involving multiple areas of the brain. These findings are consistent with the effects of status epilepticus; inflammation or other findings indicating an etiology of the patient's initial high fevers and status epilepticus were not identified in the brain or in the other organs. Features of cardiac failure and dilation were evident, but aside from minor preterminal ischemia, the myocardium was histologically unremarkable. Based upon the autopsy report, the principle diagnosis of the death was global ischemic encephalopathy and gliosis with features of cardiac failure. Cardiac failure occurred; however, the cause or causes of the fevers, seizures, and terminal cardiac failure were not identified during the clinical course or at autopsy; in particular, there was no anatomic indication of an infectious disease, an inflammatory process, or an intrinsic abnormality of the brain. Possible etiologies include a late-presenting mitochondrial disorder, another metabolic or hereditary disease, or an unknown acquired disorder of the central nervous system. The autopsy also did not determine how or whether the neurologic condition and the cardiac failure were related to each other, and an anatomic cause of the cardiac failure was not identified.
 
Event Description
On (b)(6) 2012, a hospital reported that a vns patient had passed away. The patient's generator and lead were explanted by the funeral home. The date of death was provided as (b)(6) 2012; however, no additional information was available. The patient's explanted generator, with lead still attached, was returned on (b)(6) 2012 and is currently undergoing product analysis. Programming history from the date of surgery shows that the device not programmed on. Two system diagnostics from the date of implant indicated normal results. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative
Review of programming history.
 
Event Description
Generator product analysis was approved on (b)(6) 2012. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator'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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The generator was returned programmed on to deliver therapy. The lead assembly was returned. Scanning electron microscopy of the positive coil show that pitting or electro etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. A fax from the surgeon on (b)(6) 2012, indicated that the surgeon was unaware, and no additional information was provided. Attempts to contact the pathology, neurology, neurosurgery, and medical records departments at the facility where the patient was implanted have been unsuccessful, but are still underway. Contact with the initial reporter corrected that the device was not received from the funeral home. Attempts to obtain information from the funeral home are in progress. A manufacturer's consultant present at the patient's implant surgery noted that the that the patient was a four-year-old admitted for cold symptoms two weeks ago and began having seizures have were uncontrolled with medications. The patient developed a phb (phenobarbital) toxicity. The patient was an inpatient; therefore, the neurologist was unknown. Diagnostics from the implant surgery were also provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769865
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dennis100
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« Reply #3 on: May 21, 2018, 02:01:22 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 11/11/2009
Event Type  Death   
Manufacturer Narrative

Event Description
Communication from the county medical examiner showed that the patient¿s death occurred less than 24 hours after admission to a hospital. No additional pertinent information has been received to date.
 
Event Description
The patient¿s hospital discharge summary was reviewed. The patient was seen in the er prior to his death due to apparent bowel ischemia. The patient¿s entire small bowel was found to be ischemic due to midgut volvulus. The patient¿s condition was ruled non-recoverable, and he was transitioned to comfort care and expired later that day. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient passed away as identified in an online obituary. No information on the cause or circumstances of death was apparent. The generator and lead device history records were reviewed, and it was found that all specifications were met prior to distribution. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6371043
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