Model Number 302-30 |
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 03/18/2014 |
Event Type
malfunction
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Event Description
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It was reported that device diagnostics resulted in high impedance.The physician programmed the generator off after observing the high impedance.The physician requested testing be performed.The patient was not referred for x-rays.Attempts to obtain additional relevant information have been unsuccessful to date.No surgical intervention has been performed to date.
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Event Description
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Additional information was received that the patient is undecided if she will pursue surgery.No surgical intervention has occurred 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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During the periodic programming history review, programming history was reviewed for this patient's generator.The programming history shows that high impedance was observed on (b)(6) 2014.
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Event Description
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The patient has been referred for surgery.No known surgery to replace the lead has occurred to date.
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Event Description
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The patient underwent a vns generator replacement surgery.High impedance was still present after the generator was replaced.Surgery to replace the lead has not occurred to date.The explanted generator was discarded by the facility, so product return to the manufacturer is not expected.No additional pertinent information has been received to date.
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Search Alerts/Recalls
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