Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problems
Seizures (2063); Therapeutic Response, Decreased (2271)
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Event Date 11/06/2014 |
Event Type
malfunction
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Event Description
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It was reported that the vns patient¿s device showed a high impedance condition (impedance value ¿ 9287 ohms) during an office visit on (b)(6) 2015.The patient¿s device was subsequently disabled.X-rays were taken and were reported by the physician to be unremarkable.Clinic notes were received indicating that the patient had been experiencing an increase in nighttime seizures in the past 1-2 months.The notes mention that the increase in seizures may be related to changes in medications that occurred around that time.The patient¿s medications were adjusted on (b)(6) 2015.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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Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015.The explanted devices have been returned to the manufacturer where analysis is currently underway.
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Event Description
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Analysis of the returned generator and lead was completed.Various electrical loads were attached to the pulse 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.The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance.Discontinuity was observed in both positive and negative quadfilar coils in the body region of the returned lead portions 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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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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