Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problems
Pain (1994); Seizures (2063)
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Event Date 10/01/2014 |
Event Type
malfunction
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Event Description
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It was reported that the vns patient¿s device showed high impedance (impedance value >= 10,000 ohms) during an office visit on (b)(6) 2014.The patient device was disabled.The patient had been experiencing painful stimulation since (b)(6) 2014 and experienced in increase in seizure intensity.No known surgical interventions have occurred to date.
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Event Description
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X-rays dated (b)(6) 2015 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin appears fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.
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Manufacturer Narrative
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Device manufacturing records 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.
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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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Search Alerts/Recalls
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