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Author Topic: Status Epilepticus  (Read 94514 times)
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dennis100
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« Reply #300 on: June 03, 2019, 05:23:13 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient has had a recent increase in seizure frequency and duration. It was reported that the patient normally has mostly simple partial seizures with occasional grand mal seizures, but the patient stated that she was having grand mal seizures that lasted over 30 min each in a few days and the partial seizures are also more frequent. The patient's device was tested at the doctor's office and was determined to be providing magnet activation as normal, but the patient cannot feel the magnet activation when her head is tilted to the left. Diagnostics and lead impedance were both tested, and both were found to be ok. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820308
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dennis100
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« Reply #301 on: June 05, 2019, 01:42:31 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/03/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient had a seizure the day before and a seizure 3 days before then, where the magnet was swiped during each seizure but it did not abort the seizure. The vns device had been turned on. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on the initial report that the patient was feeling discomfort at the incision site, and that she went to the er and that she had a small seizure. It was reported that the patient had a seizure on (b)(6) 2017 lasted an hour and that has never happened. Event problem codes, corrected data: event problem code for chest pain was inadvertently not provided in the initial report.
 
Event Description
The patient was feeling discomfort at the incision sites, and that she went to the er and that she had a small seizure. It was reported that the patient had a seizure on (b)(6) 2017 lasted an hour and that has never happened. As-of (b)(6) 2017, the patient provided that she was still experiencing pain in the chest and neck incision sites.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6759352
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dennis100
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« Reply #302 on: June 17, 2019, 04:42:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/12/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient had her generator replaced and that the patient¿s duty cycle was adjusted to accommodate the autostimulation feature. The patient then had a 10 minute seizure that the magnet would not abort and the autostimulation didn¿t help according to the patient. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the provider indicated that the cause of the increased seizure duration may have been due to the change made in the settings or the generator replacement surgery the day before. The magnet swiping technique had not been confirmed to be adequate. Device diagnostic results were normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6996335
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dennis100
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« Reply #303 on: June 22, 2019, 04:02:37 AM »

Model Number 101
Event Date 12/16/2010
Event Type  Injury   
Event Description
On (b)(6) 2011, clinic notes were received from the vns treating physician. Review of the clinic notes dated (b)(6) 2010 revealed that the vns patient was recently admitted to the hospital with status epilepticus. Additional information has been requested from the physician concerning this event but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2285747
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dennis100
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« Reply #304 on: June 23, 2019, 04:16:38 AM »

Event Date 08/18/2014
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized in status epileptics and was then placed into a medically induced coma. It was reported that the patient has tuberous sclerosis. If was later reported that the patient was still hospitalized in the intensive care unit. It was reported that it was decided not to turn the vns on until the patient is slabilized. The patient will undergo an mri. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4089982
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dennis100
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« Reply #305 on: July 02, 2019, 01:25:11 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/16/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient felt that her seizures had progressed. She was having 15 seizures daily that lasted between 10-15 minutes at a time. The device battery was found to be depleted. A battery life calculation was performed, which estimated 1. 7 years remaining battery life. However, the settings were from over two years prior. The patient had generator replacement surgery due to battery depletion. The generator has not been received to date.
 
Manufacturer Narrative

Event Description
The explanted device was received. Analysis was completed for the returned generator. The device output signal was monitored for more than 24 hours, while the pulse 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery was not depleted. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7594943
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