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Author Topic: New Seizure Type  (Read 19231 times)
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dennis100
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« Reply #120 on: May 20, 2019, 09:39:56 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's seizures are not controlled and that the patient is having more seizures with her vns than she did previously. Patient also reported that her seizure type has changed. She is now having seizure clusters instead of on-off seizures. This has reportedly been occurring for about a year now. Device was checked few weeks prior to the report and all of the diagnostics were normal at that point. Patient is considering having the device removed since it hasn't been helping her seizures. Patient was referred to see surgeon for explant consult. No relevant information was obtained regarding the patient's seizure control. No adjustments in dosing were made at this appointment. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6562929
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dennis100
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« Reply #121 on: June 04, 2019, 08:29:52 AM »

Model Number 103
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the patient began experiencing grand mal seizures about six moths prior. It was reported that the patient had never experienced a grand mal seizure prior to this. The patient reported that he previously only experienced petit mal seizures. The patient is scheduled to be seen by the physician, but has not been seen to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3910742
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dennis100
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« Reply #122 on: June 07, 2019, 05:20:38 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/05/2019
Event Type  Malfunction   
Event Description
Patient reported on social media that her seizures were getting worse and that she was getting seizures that were a different kind as well. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8575521
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dennis100
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« Reply #123 on: June 08, 2019, 06:12:08 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2019
Event Type  Injury   
Event Description
It was reported that the patient recently developed more frequent, possibly different type seizures. The patient's generator was replaced. The suspect product has not been received to date. Multiple attempts for additional information regarding the patient's seizures were made; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8632499
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dennis100
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« Reply #124 on: June 23, 2019, 03:57:12 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 05/05/2015
Event Type  Injury   
Event Description
It was reported that the patient experienced an unusual seizure during device settings adjustments; therefore, the physician left the settings as previously programmed. The patient reported that the seizure was different than what she was used to. Attempts to obtain additional relevant information have been unsuccessful to date. The relationship of the unusual seizure to vns is unknown.
 
Manufacturer Narrative

Manufacturer Narrative
The previously submitted mdr inadvertently provided an incorrect event date.
 
Event Description
Information was received from the neurologist via a company representative on (b)(6) 2015. The date of onset of the new seizure type was (b)(6) 2015. The patient's seizures are less severe since vns. The new seizure type is not related to vns, but is related to external factors. No interventions were planned or taken. Diagnostic results were not reported.
 
Event Description
Further reports regarding this patient's increased seizures were received and this and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4860270
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dennis100
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« Reply #125 on: June 28, 2019, 11:05:03 PM »

Model Number 105
Event Date 05/12/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient had complaints of redness, swelling, and pain at the vns generator site. The physician programmed the vns off and referred the patient back to the ent for evaluation of the site for infection. Additionally information was received which stated the patient also believes the generator is heating and not working. The patient stated he has had an increase in seizures as well as a change in seizure type. Later it was reported the physician does not feel the patient's symptoms were related to vns, but believed it was a "nerve issue". It is unknown what the nerve issue is, or what may have caused the nerve issue to occur. A x-ray assessment was provided by the physician which stated "gross satisfactory vagal nerve stimulator. No acute finding". Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes were received due to re-implant surgery referral due to a "problem with the vagus nerve stimulator". It was mentioned in the notes that the patient was still having seizures. The patient's replacement occurred on (b)(6) 2016 and it was noted he was switched from a model 105 generator back to a model 102 generator. After the generator was replaced with the new generator, the system diagnostic results confirmed the device was working as intended. It was reported by the physician's office that the patient was last seen on (b)(6) 2016 and had mild pain, redness, and 4 seizures. It was confirmed that these seizures have increased from her baseline. It was noted that an additional event had occurred which lasted for hours and the patient felt heating around the vns device. There was not reason specifically given for the increase in seizures. It was noted that the vns settings on (b)(6) 2016 were at therapeutic levels and the diagnostics were within normal limits. It was noted the device would not be returned per hospital regulations. It was further reported by the company representative who was at the surgery that the m105 was "faulty" and needed to be replaced, or per patient request, would be removed completely. The patient requested to have a 102 as he did not have any issues with the m102. Per the patient and the surgeon, the believed cause of the burning sensation and irritability was due to the 105 generator. According to the patient, the burning sensation occurred immediately after the 105 settings were adjusted, but continued even after the device was programmed off. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5726096
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dennis100
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« Reply #126 on: July 26, 2019, 01:15:34 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she believes she needs a vns replacement due to her seizures getting worse and having changed. The patient stated she was in the icu for 4 days with seizures. The patient had not seen a neurologist and was looking for a recommendation to see one however no neurologist appointment is known to have occurred. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7916429
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dennis100
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« Reply #127 on: September 07, 2019, 12:00:35 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/17/2019
Event Type  Injury   
Event Description
It was reported from the patient¿s mom that the patient's seizures have "changed character" and is wondering if it could be due to battery depletion or the patient's brain lesions. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8880492
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