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 03/01/2014 |
Event Type
malfunction
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Event Description
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Further follow-up revealed that the patient's mother denied any trauma that may have caused or contributed to the high impedance.It was reported that the patient's mother does not want the replacement surgery at this time.X-rays were sent to manufacturer for review.Based on the x-ray images provided, the cause for the report of high impedance could not be determined.The portion of the lead behind the generator and the portion of the lead not visible due to the image quality could not be assessed, therefore a lead fracture in those areas cannot be ruled out.The presence of a micro-fracture in the lead also cannot be ruled out.
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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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Event Description
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It was reported that the patient's device showed high impedance.It was reported that x-rays were taken and were unable to see if the lead was disconnected.The patient's device is currently off.The physician indicated that he wanted to send the x-rays to manufacturer for review.X-rays have not been received to date.It was reported that the patient was referred to surgical consult.It was later reported that there were no plans to replace the vns at this time.The patient will be evaluated for visualaese surgery first before a final decision will be made regarding either surgery.No surgical intervention has been performed to date.
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Manufacturer Narrative
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Device manufacturing records were reviewed.Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.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 was expected to undergo surgery.No known surgical interventions have occurred to date.
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Event Description
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It was reported that the patient underwent generator and lead replacement.The generator was replaced due to battery depletion.It was reported that only the generator would be returned for analysis.The generator was received for analysis on 11/17/2014.Analysis of the generator was completed on 12/08/2014.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.
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Search Alerts/Recalls
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