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 09/24/2014 |
Event Type
malfunction
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Event Description
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It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (dc dc -7).The patient¿s device was not disabled following the high impedance observation.X-rays were taken and reported by the physician to be unremarkable.The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The generator was replaced prophylactically.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
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Event Description
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Operative notes were received indicating that the vns patient¿s generator was tested with a test resistor and generator diagnostic results showed normal device function.Analysis of the returned generator and lead was completed.There were no anomalies found with the pulse generator.The generator performed according to functional specifications.Analysis of the returned lead portion confirmed discontinuity of both positive and negative quadfilar coils in the electrode region.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.
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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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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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