Model Number 104 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
Convulsion, Clonic (2222)
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Event Date 11/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that a generator had experienced a device reset unexpectedly - programmed to 0 ma.As a result, it did not provide stimulation and the patient experienced an increase in daytime seizures.The manufacturers device history records of the generator were reviewed.The generator passed final functional and quality specifications prior to release for distribution.No further relevant information has been received to date.
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Event Description
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Internal programming data form the generator was reviewed and showed hardware reset, which was later cleared.Per the data, the generator reset time was on (b)(6) 2021.Impedance and voltage was okay/normal no other anomalies outside of the hardware reset was identified.There was no interrogation of the vns on that date.Internal investigations of similar events reported that while the root cause is undetermined, the issue appears to be related to temporary power loss within the generator related to an unknown hardware failure that may have contributed to an intermittent loss of power.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.
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Event Description
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Surgery occurred to replace the generator.The explanted generator has not been received for analysis to date.
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Event Description
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The generator was received for analysis.Product analysis is underway but has not been completed to date.
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Event Description
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Product analysis was completed and approved on the generator.The generator reset was verified in the lab.In addition, review of the data shows a instance where the hardware reset status did appear 12/15/2021.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Other than the noted event, there were no additional performance, or any other type of adverse conditions found with the pulse generator.
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Manufacturer Narrative
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10.Adverse event problem - health effect; corrected information; second supplemental mdr inadvertently omitted replacement coding.
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Event Description
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An addendum internal investigation was performed for the generator reset.New information was received that dendritic growth was observed on the routed edge of the printed circuit board assembly.It is believed that conductive residues deposited on the edge of the circuit board during the laser-routing manufacturing process.The growth likely created current paths that caused unintended electrical function, which were theorized to burn out, grow back and cause a reset, and burn out again.Therefore the probable root cause is considered related to the laser-routing process.
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Search Alerts/Recalls
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