Model Number 302-20 |
Device Problems
High impedance (1291); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/05/2015 |
Event Type
malfunction
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Event Description
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Analysis of the explanted generator was completed.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis of the explanted lead was completed.A break was identified in the positive coil.Scanning electron microscopy images of the positive coil broken ends and strand fragments show that pitting or electro-etching conditions have occurred at the break location.However, due to metal dissolution, mechanical distortion (smoothed surfaces), and /or surface contamination the fracture mechanism cannot be ascertained.Abraded openings of both the outer and inner silicone tubing were also observed near the break location with dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
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Manufacturer Narrative
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Device failure occurred, 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 that the patient underwent generator and lead replacement surgery due to prophylactic generator replacement and lead discontinuity.System diagnostics following revision showed normal results without high impedance.The generator and lead were received for product analysis.Analysis is currently underway but has not been completed to date.
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Event Description
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It was reported that the vns patient¿s device showed low output current delivered and high lead impedance.The device was disabled and the patient was sent for x-rays.No known surgical interventions have occurred to date.
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Manufacturer Narrative
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Device failure is suspected, but did not cause or contribute to a death or serious injury.
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Search Alerts/Recalls
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