Model Number 302-20 |
Device Problems
High impedance (1291); Unexpected Therapeutic Results (1631)
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Patient Problems
Seizures (2063); Therapeutic Response, Decreased (2271)
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Event Date 07/01/2015 |
Event Type
malfunction
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Event Description
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It was reported that the patient had experienced an increase in seizures over the past two months.Interrogation and diagnostics of the vns device showed high impedance results.No known trauma was reported to have occurred.Patient is referred for a full revision of the generator and lead as a result.Clinic notes were received stating that the patient's seizures have increased.Patient was also reported to be blacking out with seizures and is no longer able to hear during the seizures.No known surgical interventions have occurred to date.
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Event Description
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The patient underwent full revision surgery on (b)(6) 2015.Attempts were made for the return of the explanted lead and generator but only the generator was received on (b)(6) 2015.Analysis is underway but has not been completed.
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Event Description
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Analysis was completed on the returned generator and the generator performed according to functional specifications.During the product analysis, there were no anomalies found with the pulse generator.
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Search Alerts/Recalls
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