Model Number 302-20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 08/01/2014 |
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 revealed high impedance (impedance value = 10,000 ohms).A few months prior to the observed high impedance condition, the patient was experiencing shocking sensations at his neck which had recently resolved.No known surgical interventions have occurred to date.X-rays were taken and were reported by the physician to be unremarkable.X-rays dated (b)(6) 2014 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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Manufacturer reviewed x-rays of implanted device.X-rays reviewed by manufacturer, no gross lead discontinuities visualized.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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Additional information was received stating that the vns patient underwent surgery on (b)(6) 2015 to explant his device.The patient¿s family elected not to replace the system as the patient had been seizure-free for over a year.The explanting facility misplaced the explanted devices and was unable to return the devices to the manufacturer; therefore, no analysis can be performed.
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Search Alerts/Recalls
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