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Author Topic: Deep brain stimulator - Seizures  (Read 49579 times)
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dennis100
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« Reply #120 on: July 15, 2015, 11:51:30 PM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant product(s): product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387-40, lot# l75839, implanted: (b)(6) 2000, product type lead: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 3387s-40, lot# va01k4q, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

Event Description
It was reported the patient has had seizures since (b)(6) 2014. The seizures were not a pre-existing condition and during the last two months the seizures had increased in frequency. The seizures lasted about 10 to 15 seconds. Two days prior to this report the patient had six seizures in a row with about a 20 second break in between. The patient was taken to the emergency room and a ct scan was done, but there was not enough detail to determine the cause. The patient had a right lead replaced in 2010 or 2011. An appointment with the patient¿s healthcare professional was scheduled for the day of this report. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent. Refer to manufacturer report #3004209178-2015-11827.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4853505
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dennis100
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« Reply #121 on: August 08, 2015, 09:51:20 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported the patient had increased seizures on stressful days, tension from work and a new location, and anxiety. It was also reported etiology was programming/stimulation; vibration when stimulation was on and stopped. On (b)(6) 2010, therapy was suspended. Stimulation was turned off at night via ¿atc. ¿ on (b)(6) 2010, the patient was reprogrammed two minutes on and one hour off; it was also reported therapy was suspended. On (b)(6) 2010, the patient was reprogrammed; returned to cycling parameters of two minutes on and one hour off. It was also reported therapy was suspended on june 3. On an unknown date an intervention was performed of temporary direct current of stimulation via ¿atc. ¿ on (b)(6) 2010, therapy was suspended. On (b)(6) 2010, the patient was reprogrammed from 2 volts, pulse width of 120, 2 minutes on and one hour off to 3 volts, pulse width of 150, 2 minutes on and 0. 5 hours off; it was also reported therapy was suspended. It was noted there were no hospitalizations related to this event. The event was ongoing.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v020086, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v020086, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7436, serial # (b)(4), implanted: (b)(6) 2004, product type programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4931734
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dennis100
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« Reply #122 on: September 07, 2015, 07:59:01 AM »

Model Number 7428
Event Type Injury
Event Description
The patient reported that she had two seizures and they only happened when she was using her patient programmer. The first occurred in (b)(6)2015 and the other occurred on (b)(6) 2015 when someone was checking the 9 volt battery in the programmer. Her indication for use was other. No interventions or patient outcome were reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, implanted: (b)(6) 2009, product type: extension. Product id: neu_unknown_lead, product type: lead. Product id: neu_ptm_prog, product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5005173
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