Model Number 300-20 |
Device Problem
High impedance (1291)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/10/2014 |
Event Type
Malfunction
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Event Description
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Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.
The explanting facility discarded the explanted device; therefore, no analysis can be performed.
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Event Description
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It was reported that the vns patient¿s device showed high impedance (impedance value ¿ 6102 ohms) and an ifi condition during an office visit on (b)(6) 2014.
Clinic notes were received indicating that the patient device was working well on (b)(6) 2014.
The patient was referred for surgery but no known surgical interventions have occurred to date.
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Manufacturer Narrative
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Device failure is suspected, but did not cause or contribute to a death or serious injury.
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Event Description
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Additional information was received stating that the vns patient had a bad seizure and was subsequently hospitalized.
The patient had also been experiencing painful stimulation in the neck region.
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Search Alerts/Recalls
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