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Author Topic: Increase/Worsening of Seizures  (Read 577661 times)
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dennis100
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« Reply #3960 on: August 11, 2018, 01:47:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported from the patient¿s mother that the patient was implanted in (b)(6) 2017 and in (b)(6) 2017 the device was titrated up to therapeutic levels and he began to have more seizures. She has continued to follow up with the neurologist and the device has been titrated up in response to the increased seizures. However, she suspected that vns was causing the increase in seizures so she taped the magnet over the device and his seizures stopped. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7695401
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dennis100
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« Reply #3961 on: August 12, 2018, 12:23:02 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that within two weeks of a patient's generator replacement, she experienced an increase in seizures. The device was reportedly turned on in the or after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7674953
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dennis100
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« Reply #3962 on: August 15, 2018, 03:42:36 AM »

Model Number 102R
Event Date 10/01/2012
Event Type  Malfunction   
Event Description
The treating physician's office reported that the patient suspects the battery has depleted, as she was recently experiencing an increase in seizures. The caregiver believes that the battery may need to be replaced. However, it was noted that the near end of service flag is not triggered. The physician requested a battery life calculation be performed. There has been no indication to date that any intervention has been taken or planned. Attempts for additional information from the physician's office have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2809962
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