Model Number 302-20 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
Pain (1994)
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Event Date 07/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient's generator and lead were explanted because the patient claimed that the vns was shocking her.The explanted lead and generator were returned.Product analysis was completed on the returned portion of the lead.A portion of the lead and the electrodes were not returned and thus, could not be evaluated.Multiple abraded openings were noted on the outer and the inner silicone tubing of the returned lead portions.Fluid within the inner and outer tubing was also identified with no other point of entry besides the abraded openings and cut ends.No further anomalies or any discontinuities were identified.No further relevant information has been received to date.
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Event Description
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Product analysis was completed on the returned generator.The generator was monitored for 24 hours in a simulated body temperature environment.The generator provided the intended output current for the entirety of the monitoring period.A comprehensive electrical evaluation showed that the device performed according to functional specifications.Per the internal data of the generator, high impedance was detected prior to device explant.No further relevant information has been received to date.
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Event Description
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It was reported that when high impedance was detected, the patient's generator was disabled.In addition, x-rays of the patient's neck taken after explant were received and reviewed.Only a small portion of the lead (including the electrodes) was left implanted per the images.There was no evidence of a lead fracture in this portion of the lead.However, this does not rule out the possibility of microfractures.No further relevant information has been received to date.
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Search Alerts/Recalls
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