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Author Topic: Increase/Worsening of Seizures  (Read 843590 times)
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dennis100
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« Reply #4230 on: June 11, 2019, 01:28:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/26/2018
Event Type  Injury   
Event Description
It was reported that the patient experienced an increase in seizure frequency and was referred for generator replacement surgery. The company representative reported that the patient's settings were high, in reference to their referral for generator replacement. The patient's implant card indicated that the generator replacement was prophylactic. Prior to the replacement surgery the patient's lead impedance was within normal limits. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8177102
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dennis100
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« Reply #4231 on: June 13, 2019, 03:45:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Event Description
Report received that a patient presented with an increase in seizures in the clinic. During the same visit, it was reported that the patient did not feel magnet mode stimulation and the magnet no longer affected her seizures. The generator was also unable to be interrogated by the physician's programmer. This combination of events reportedly led the physician to believe the device had reached end of service and resulted in the referral for generator replacement surgery. At the patient's previous appointment about 6 months before, there was no indication the generator's battery was depleting. The vns settings were also provided from the interrogation performed during that appointment. The patient not feeling her magnet was also reported to have occurred during this previous appointment. System diagnostic results and pre-vns frequency levels were not provided. The physician's programmer was reportedly able to interrogate other generators after having a failure on this patient's generator. No surgical intervention has occurred to date. No further relevant information has been provided to date.
 
Event Description
Further information was received that the patient's generator was replaced. The generator has not been received by the manufacturer to date. No further relevant information has been obtained.
 
Event Description
Further information was received that the generator had been received for product analysis by the manufacturer. This analysis was later completed. Visual inspection did not identify any surface anomalies outside of the typical markings associated with implant and explant procedure. The device was able to be interrogated and system diagnostic testing was successfully performed. All results were normal. A test using magnet activation and disablement found that the reed switch was operating as expected. The generator was also tested in a simulated bodily environment and no changes or variations in output current were identified. A comprehensive automated electrical evaluation also showed that the pulse generator performed according to functional specifications. The data from the generator also did not show any anomalies. Proper functionality of the generator in its ability to provide appropriate programmed output currents was verified in product analysis. Updated programming data was also reviewed. The only available data was from the day of explant but it showed that the impedance was within normal limits. The battery status was also found to be functional. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7077230
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dennis100
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« Reply #4232 on: June 14, 2019, 06:26:28 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/29/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported through clinic notes that the patient's vns battery status was 11-25% remaining,, so he needed to have a generator replacement soon. It was then indicated that the surgeon would need to be notified as the patient's seizures were increased. It was then reported that the increased seizures was how the mother knew that the battery was low. It should be noted that the patient's generator is designed to provide it's intended therapy until it's fully depleted, at which point the generator disables itself. High impedance was not reported. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8659874
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dennis100
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« Reply #4233 on: June 14, 2019, 06:28:26 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
Report received through clinic notes that a patient presented with an increase in seizures. The patient's seizures increased from 10 days of seizures per month to 15 seizures per month over a span of about six months. The patient's generator was interrogated in the clinic and the settings were provided. It was stated that the generator was at end of service but the physician also indicated that battery life still remained. A review of the programming history only provided data from the day of implant, but showed diagnostics were normal at the time. The patient's generator was replaced and the generator was returned to the manufacturer. Product analysis has not been completed to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the generator. Besides normal markings and discoloration seen with the implant and explant procedure, no visual anomalies were seen. The generator was interrogated and system diagnostics were run. All results were normal. The generator output was monitored in a simulated body environment and did not show any variation in expected output current. The generator also passed all electrical tests and performed according to all specifications. The battery voltage was measured and indicated the generator had been able to provide stimulation prior to explant. The data from the generator was also reviewed and did not show any anomalies. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7047049
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