Model Number 300-20 |
Device Problem
High impedance (1291)
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Patient Problems
Seizures (2063); Therapeutic Response, Decreased (2271)
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Event Date 06/01/2014 |
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 experienced an increase in seizures the past summer following a fall.The patient was referred for surgery but no known surgical interventions have occurred to date.The patient had been doing well with vns.It was noted that the patient had also been experiencing chest pain which was attributed to lateral device migration in the chest which occurred shortly after implant surgery.
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Event Description
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Additional information was received stating that x-rays were taken for the patient and the physician's office was able to visualize a lead fracture in the x-rays.Thus, the patient was referred for revision surgery.The lead fracture is thought to be due to the patient's fall over the summer, though this cannot be confirmed.The patient's recent increase in seizures is thought to be related to a loss of therapy from the high impedance.The increased seizure rate is around pre-vns levels.No known surgical interventions have occurred to date.Good faith attempts for additional relevant information have been unsuccessful.
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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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Event Description
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Additional information was received that the patient underwent vns generator and lead replacement surgery on (b)(6) 2015 due to high lead impedance.The generator was replaced prophylactically.The explanted generator and lead were received by the manufacturer for analysis.Analysis of the generator concluded that the device performed according to functional specifications.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.Analysis of the lead confirmed a discontinuity of the positive quadfilar coil in the body region of the returned lead portions.The analysis also observed abraded openings of both outer and inner tubing near the break area with associated fluid leaks.Pitting was also observed on the coils at the break location.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.
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Event Description
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Analysis of the lead identified that there were abraded openings in the outer and inner tubing in one area.For the observed fluid leaks, there were only observed in the inside of the outer tubing (not inner tubing).
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Search Alerts/Recalls
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