Model Number 300-20 |
Device Problem
High impedance (1291)
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Patient Problem
Discomfort (2330)
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Event Date 03/20/2015 |
Event Type
malfunction
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Event Description
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The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
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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.Pre-operative diagnostic results showed a high impedance condition (impedance value >= 10,000 ohms).The explanted devices have not been returned to date.
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Event Description
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It was reported that device diagnostics resulted in high impedance (>10,000 ohms).X-rays were taken and device settings were increased.It was reported that the patient would be referred for surgery and x-rays would be sent to manufacturer for review.It was later reported that the increased settings caused the patient to have a "chewing on foil" sensation when turning his head.The device was later disabled.X-rays were received by manufacturer to review.Review of x-rays did not identify any obvious discontinuities with the vns system; however, a micro-fracture could not be ruled out.It was reported that the patient plans on undergoing oral surgery prior to vns system replacement.No known surgical interventions have occurred to date.
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Manufacturer Narrative
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Manufacturer reviewed x-rays of implanted device.X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
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Search Alerts/Recalls
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