Model Number 300-20 |
Device Problems
High impedance (1291); Failure to Deliver (2338)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/23/2013 |
Event Type
malfunction
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Event Description
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It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance.The physician declined to program off the device.Additional information was received that during an office visit on (b)(6) 2014, diagnostic results confirmed high impedance (impedance value >= 10,000 ohms) and that no stimulation was being delivered (output current ¿ 0 ma).No known interventions have occurred to date.No patient manipulation or trauma was reported.It is unknown if x-rays were taken or when the last normal diagnostic results were observed.
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Event Description
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An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The explanted products have not been returned to the manufacturer to date.
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Manufacturer Narrative
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Device manufacturing records were reviewed.Review of manufacturing records for 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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Attempts for product return showed that the explanted devices were discarded after explant.Review of programming history showed that high impedance was first observed upon interrogation on (b)(6) 2014.Review of the decoder data indicates that the impedance value changed from 3119 ohms to 12965 ohms on (b)(6) 2013.Based on the information in the decoder, impedance was within normal limits at the time of implant and for about a month after implant.
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Manufacturer Narrative
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Analysis of programming history date of event, corrected data: review of available information shows that the change in impedance to high impedance occurred on (b)(6) 2013.
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Search Alerts/Recalls
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