Model Number 103 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Seizures (2063)
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Event Date 08/28/2013 |
Event Type
Injury
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Event Description
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It was reported through clinic notes the patient felt that vns was not helpful for her.The patient later reported that she had her vns programmed off on (b)(6) 2015, no reason was given, and that using the magnet made her seizures worse.The patient stated her seizures increased during the time she was receiving vns therapy.Additionally, she stated she was willing to give vns another try.Attempts for additional relevant information have been unsuccessful to date.
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Event Description
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It was reported the patient had a generator replacement on (b)(6) 2016.The replacement was noted to be prophylactic.Attempts for additional information have been unsuccessful to date.
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Event Description
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The explanted generator was received by the manufacturer for analysis.Product analysis is expected but has not been completed to date.
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Event Description
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Product analysis for the explanted generator was completed.The device output signal was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment.The results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period.A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications.An end of service warning message was verified and found to be associated with the output being disabled by the generator.Burn marks were observed on the generator case, which indicated the generator may have been exposed to an electro-cautery tool during device explant.A reset of the device allowed for an output current to once again be provided for subsequent generator testing.The battery voltage was measured and confirmed an ifi = yes (intensified follow-up indicator) condition.Other than the noted pulse disabled event, there were no additional performance or any other type of adverse conditions found with the generator.
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Search Alerts/Recalls
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