Model Number 300-20 |
Device Problems
High impedance (1291); Battery Problem (2885)
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Patient Problem
No Code Available (3191)
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Event Date 11/13/2014 |
Event Type
malfunction
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Event Description
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The explanting facility did not discard the devices.The explanted products and opened but unused generator were returned to the manufacturer for analysis.No abnormal performance or any other type of adverse condition was found with the explanted and unused generators.The devices performed according to functional specifications.Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the body region.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Abraded openings were observed on both the outer and inner tubing near the break area.The abraded openings found on the (-) unmarked connector pin inner silicone tubing 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 inner silicone tubing.
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Manufacturer Narrative
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Device failure occurred, but did not cause or contribute to death or serious injury.
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Event Description
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The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
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Event Description
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It was reported that the vns patient was scheduled for generator replacement surgery on (b)(6) 2014 due to end of service.Pre-operative system diagnostic results showed lead impedance within normal limits (dcdc ¿ 2).After the patient¿s generator was replaced, the replacement generator was tested with the existing lead and diagnostic results revealed high impedance (impedance value -10,000 ohms).The lead was replaced and another generator was implanted due to device compatibility.It was noted that the surgeon handled the patient¿s lead somewhat roughly prior to its replacement.Operative notes were received indicating that the surgeon observed damage to the lead during the procedure so the lead was also replaced.The explanted devices and the opened but unused generator have not been returned to date.
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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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Search Alerts/Recalls
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