Model Number 300-20 |
Device Problem
High impedance (1291)
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Patient Problem
No Code Available (3191)
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Event Date 12/12/2014 |
Event Type
malfunction
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Event Description
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It was reported that device diagnostics resulted in high impedance (>= 10,000 ohms).It was reported that device diagnostics on (b)(6) 2014 were within normal limits.The patient was referred for x-rays.An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity.The generator was replaced prophylactically.The explanted devices are expected to be returned for analysis, but have not been received 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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Event Description
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The explanted devices were received by the manufacturer for analysis.Analysis of the returned lead portion confirmed discontinuity of positive quadfilar coil in the body region and abraded openings of both outer and inner tubing near the break location.The abraded openings found on the outer 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 outer silicone tubing.Pitting was observed on the coil surface.Analysis of the returned generator is currently underway.
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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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Analysis of the returned generator was completed.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery showed an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.
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Search Alerts/Recalls
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