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Author Topic: Status Epilepticus  (Read 69830 times)
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dennis100
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« Reply #270 on: June 08, 2018, 03:56:47 AM »

Device Problem No Known Device Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital for increased seizures and one episode of status, which was not normal for patient. The patient also experiences a tingly feeling in their neck. Patient's generator could not be interrogated at the time of report. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7542540
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dennis100
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« Reply #271 on: June 10, 2018, 01:13:49 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/27/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was experiencing increased seizures up to 20 seizures per day, increased seizure intensity, and a status epilepticus event following vns implantation. Per the physician, the cause of these events was unknown. It was also reported that the patient had hoarseness and food swallowing complications when the magnet was used. Settings changes were made for the patient's increased seizures, increased seizure intensity, status epillepticus event, hoarseness, and food swallowing issues. It was later reported that the patient was doing better following the settings changes. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7488128
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dennis100
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« Reply #272 on: June 30, 2018, 02:40:37 AM »

Model Number 106
Event Date 10/28/2016
Event Type  Death   
Event Description
It was reported that the patient was hospitalized due to feeling sick and having a few seizures, which were not alleged to be related to the patient's vns. The patient was intubated and experienced cardiac arrest while in the emergency department. The patient was then transferred to the icu, and a brain mri was scheduled. It was later reported that the patient was placed on life support on (b)(6) 2016 and was deemed brain dead. The patient passed away on (b)(6) 2016, and the device was not explanted. Attempts for further information were unsuccessful to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The death summary from the patient's hospitalization was provided. The patient presented at the emergency room after he had a seizure, administered ativan, and was taken to the hospital by emergency medical services. The patient had a history of seizure disorders and developmental delay. The patient also had a urinary tract infection. The initial assessment upon the patient's arrival was encephalopathy postanoxic, postictal cardiac arrest, pulseless electrical activity (pea), postanoxic myoclonus, status epilepticus, acute respiratory failure, and elevated hepatic enzymes. The patient was given antiepileptic medications while in the hospital. The patient also had evidence of kidney injury, and the assessment was acute kidney injury, metabolic acidosis, and anemia. The patient was in the icu, and the assessment was that the patient had respiratory to cardiac arrest, secondary to seizure and ativan administration. A chest x-ray revealed a left lower lobe infiltrate and presumptive pneumonia. Subsequent to this, the patient remained in an anoxic state and ventilator dependent. An mri was performed, which was consistent with anoxic brain injury. The patient's family and physicians decided to remove the patient from life support, and the patient passed away due to respiratory failure secondary to anoxic encephalopathy.
 
Event Description
The physician provided the patient's device settings, but diagnostic results were not provided. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6122170
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dennis100
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« Reply #273 on: July 06, 2018, 11:16:24 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was indicated that a patient on "normal cycling" stimulation had reduced seizures, and no noted issues with vns. A day after a 0. 5ma increase in output current from 1. 5ma to 2. 0ma, the patient developed secondary generalized clonic seizures on the left side of her face and was hospitalized due to status epilepticus. The vns was suspected to be the cause of the status epilepticus. The vns was turned off, and the patient no longer had generalized tonic clonic seizures. The seizures gradually decreased and subsided after one day. The vns remained off for two days, and then was turned back on and slowly titrated. It was noted that the patient's condition has been stable with medication and vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7573497
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dennis100
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« Reply #274 on: August 10, 2018, 04:18:16 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/06/2015
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an episode of status epilepticus. It was reported that the patient was referred for vns replacement at that time, but the replacement was refused since the generator's battery was not depleted at that time. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709551
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dennis100
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« Reply #275 on: August 15, 2018, 03:39:30 AM »

Model Number 103
Event Date 10/01/2011
Event Type  Injury   
Event Description
It was reported that the patient was implanted with vns without complication and started titration. Every second day the patient was titrated up 0. 25 ma to 0. 75 ma without any side effects. The patient was admitted to the hospital in status epilepticus on (b)(6), 2011. The patient experienced two episodes where she stopped breathing during this status event. Patient was treated with medication for the status. The stimulator was stopped with the magnet and later programmed to 0 ma on (b)(6), 2011. The relationship of the event to vns is unknown, per physician. The patient has had no further episodes since the status epilepticus was stopped.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2325710
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