Model Number 300-20 |
Device Problems
Premature Discharge of Battery (1057); High impedance (1291)
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Patient Problem
Seizures (2063)
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Event Date 05/04/2011 |
Event Type
malfunction
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Event Description
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During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2011 and system diagnostic results revealed high impedance (dc dc ¿ 7).Clinic notes from the patient¿s office visit on (b)(6) 2014 indicate that the patient was having as many as 10 seizures per day.It was noted that the patient¿s magnet was not aborting the patient¿s seizures.A battery life calculation using the available programming history show 0 years remaining until eri = yes.The patient was referred for surgery but no known surgical interventions have occurred to date.
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Event Description
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Analysis of the returned generator and lead was completed.The end of service condition of the explanted generator was determined to be the result of normal battery depletion.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.Discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portion was confirmed where abraded openings were observed on the outer and both inner silicone tubes and tie down location.The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes.Pitting was observed on the coil surface.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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Event Description
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Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.The patient¿s explant device could not be interrogated which was suspected to be due to an end of service condition of the device.The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
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Manufacturer Narrative
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Review of the available programming and diagnostic history.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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