Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problems
Seizures (2063); Injury (2348)
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Event Date 03/06/2014 |
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 showed high lead impedance (impedance value - 6709 ohms) during an office visit on 03/06/2014.X-rays were taken but have not yet been provided to manufacturer for evaluation.The device was not disabled.The patient is often injured because she has drop attack seizures, which may have caused or contributed to the reported high impedance.However, no definitive conclusions can be made with the available information.Review of the available programming and diagnostic history showed normal diagnostic results through 08/01/2013.No known interventions have occurred to date.Attempts for additional relevant information were made but have been unsuccessful to date.
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Event Description
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Additional information was received indicating that the patient underwent surgery.During the surgery, a new generator was attached to the existing lead and device diagnostics were within normal limits (3767 ohms).It was reported that the patient's head and neck were placed in different positions and subsequent diagnostics were within normal limits.The surgery was finalized with only generator replacement.It was later reported that device diagnostics again resulted in high impedance (>10,000 ohms).The generator was programmed off and the patient was referred for lead replacement.No known surgical intervention have been performed to date.The generator was received for analysis on (b)(4) 2014.Analysis is underway, but has not been completed to date.
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Event Description
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Additional information was received stating that the vns patient underwent lead replacement surgery on 09/05/2014 due to lead discontinuity.The explanted lead has been returned to the manufacturer where analysis is currently underway.
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Event Description
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Analysis of the generator was completed on 08/07/2014.Results of the analysis will be reported on the quarterly remedial actions exemption report.
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Event Description
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Analysis of the returned lead was completed.During the visual analysis, connector pin and connector ring quadfilar coils appeared to be broken.Pitting was observed on the coil surfaces.Remnants of dried body tissue were observed wrapped around a portion of helical and green electrode ribbon.This condition may have prevented the green electrode ribbon from coming in contact with the vagus nerve.The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.With the exception of the observed discontinuities and the tissue-covered green electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.
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Manufacturer Narrative
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Device manufacturing records and available programming and diagnostic history were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death or serious injury.
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Manufacturer Narrative
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Device failure occurred, but did not cause or contribute to death.
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Search Alerts/Recalls
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