Model Number 302-20 |
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 12/15/2014 |
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.The patient had also been experiencing an increase in seizures.The patient was sent for x-rays and referred for surgery.No known surgical interventions have occurred to date.
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Event Description
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An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.The explanted devices have not been returned to date.
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Event Description
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The explanted generator and lead were returned to the manufacturer for analysis which confirmed discontinuity of negative quadfilar coil in the body region of the returned lead portion.Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting.Pitting was observed on the coil surface.Abraded openings of both outer and inner tubing were observed near the break location.The abraded opening and tear 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.There were no performance or any other type of adverse conditions found with the pulse generator.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
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Manufacturer Narrative
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Device failure is suspected, but did not cause or contribute to a death.
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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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