Model Number 106 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/21/2017 |
Event Type
malfunction
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Event Description
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It was reported that a vns patient was referred for replacement due to battery depletion however the device had not been implanted for a full year at the time of referral.The downloaded programming data was reviewed.The data on (b)(6) 2017 shows that the voltage dropped to 2.105 volts from 3.378 volts and displayed a near end-of-service-condition.The voltage was then shown to have recovered on (b)(6) 2017 to 3.445 volts and was no longer at a near end-of-service-condition.The lead impedance was within normal limits at 2,144 ohms and 1,205 ohms (b)(6) 2017 and (b)(6) 2017 respectively.Additional relevant information has not been received to-date.No known surgery has occurred to-date.
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Event Description
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Generator replacement surgery occurred.The explanted device was discarded by the hospital.
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Manufacturer Narrative
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Event description, corrected data: it was inadvertently not provided on the initial report that the cause of the premature depletion was most likely the result of the use of electrocautery during surgery on (b)(6) 2017.Event codes, corrected data: the event codes were inadvertently provided incorrectly on the initial report.
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Event Description
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From review of the data available, the cause of the premature depletion was most likely the result of the use of electrocautery during surgery on (b)(6) 2017.
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Search Alerts/Recalls
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