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Author Topic: Increase/Worsening of Seizures  (Read 607467 times)
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dennis100
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« Reply #3990 on: September 11, 2018, 03:09:42 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/23/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in seizures. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343775
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dennis100
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« Reply #3991 on: September 11, 2018, 03:10:30 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/11/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a distributor that a patient¿s vns was explanted per the family¿s decision as the ¿patient continued with seizures despite control of programming¿. When making adjustments to the parameters the seizures were reported to have increased. The lead impedance was not known. The explanted devices have not been received by the manufacturer to-date.

Manufacturer Narrative

Event Description
The explanted generator was received and analysis was completed. The device output signal was monitored for more than 24 hours, while the 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 diagnostics were as expected for the programmed parameters. Electrical evaluation showed that the generator performed according to functional specifications. The battery measured 3. 016 volts and was not in a depleted condition. The downloaded data revealed that 13. 144% of the battery had been consumed. 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=7274988
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dennis100
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« Reply #3992 on: September 13, 2018, 02:31:54 AM »

Model Number 102
Event Date 04/06/2010
Event Type  Injury   
Event Description
It was reported that a vns pt experienced an increase in seizures due to unk reason. Further info from the treating nurse indicated medications were increased and a battery life calculation was requested. The results of the battery life calculation indicated the pt's device had not reached end of service. Recent diagnostics indicated the device to be working within normal limits. Follow-up with the treating nurse through a company rep indicated that it is unk as to what caused the pt's increase in seizure activity as it was above pre-vns level. Furthermore, other factors that could have contributed to the pt's increase were possible generic medication switch.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1667281
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dennis100
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« Reply #3993 on: September 13, 2018, 02:32:26 AM »

Model Number 101
Event Date 07/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the physician that the pt recently showed increase in seizures. Physician was not sure why the pt showed increase in seizures all of a sudden. No additional info was provided. Good faith attempts to obtain additional info has been unsuccessful till date. The cause of event is unk at the moment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1823575
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dennis100
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« Reply #3994 on: September 14, 2018, 08:30:57 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
Product analysis has been completed on the explanted generator and no anomalies were noted. The generator performed according to functional specifications.

Event Description
Additional information received revealed that the patient underwent generator revision surgery where the generator was explanted and replaced prophylactically. The explanted generator has been returned to the manufacturer for analysis; however, the analysis has not been completed at this time.

Manufacturer Narrative
Analysis of programming/device diagnostic history performed.

Event Description
It was reported via clinic notes dated (b)(6) 2011 that the patient has had seven generalized tonic-clonic seizures this year when typically, the patient will have one or two a year. The physician adjusted the patient's device settings by increasing the pulse width to 500 usec and increased the duty cycle from 16% to 25%. The magnet pulse width was also adjusted however no details surrounding that adjustment were provided. The patient will be referred for generator replacement surgery as she has been implanted with the same generator for five years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2327437&pc=LYJ
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dennis100
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« Reply #3995 on: September 15, 2018, 02:08:23 AM »

Model Number 102
Event Date 10/01/2010
Event Type  Malfunction   
Event Description
It was reported that the pt was experiencing an increase in seizures. X-rays were received and reviewed by the mfr. Upon review, no anomalies were noted with the device. Attempts for further info have been unsuccessful to date.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no anomalies visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898607
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dennis100
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« Reply #3996 on: September 17, 2018, 11:59:20 AM »

Model Number 102R
Event Date 01/01/2010
Event Type  Death   
Event Description
Additional information was received from the patient's treating physician indicating that the patient died in (b)(6) 2004 and the death was believed to be unrelated to vns. No further information was available from the physician.

Manufacturer Narrative

Event Description
It was reported through a scientific article that a vns patient died a sudden unexpected death in epilepsy after 9 years of successful vns treatment. About 4 months prior to death, the patient had fallen on ice and subsequently experienced a worsening of her seizure control. At 3. 5 months later, the vns was explanted and a new one was implanted. Eleven days after the operation, the patient was found dead. Investigations post mortem did not reveal any problems with the new stimulator, but the cable was twisted. At the moment, the cause of death and the relationship to vns therapy is unknown. Good faith attempts to obtain further information regarding the event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2373884
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