Model Number 304-20 |
Device Problems
Corroded (1131); Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problems
Inflammation (1932); Seizures (2063)
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Event Date 10/10/2017 |
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 this patient recently had a generator replacement, where pin insertion was checked, and lead impedance was ok at the time of replacement, but high lead impedance was observed a few days after the replacement.It was reported that the patient has experienced a significant increase in seizures that are stronger than their usual seizures.The patient also exhibits swelling on the left side of the neck as well as a low grade fever.No known surgical intervention has occurred to date.
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Event Description
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It was reported that the patient's lead was replaced.The device has not been received by the manufacturer to date.No other relevant information has been received to date.
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Event Description
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The lead has been received by the manufacturer for product analysis.Analysis is underway but has not been completed to date.No other relevant information has been received to date.
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Event Description
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Lead analysis was completed.Abraded openings were noted on the outer and the inner silicone tubing where dried remnants of what appear to have once been body fluids were present within the inner and outer silicone tubing.There was corrosion observed on the connector pin and there was indication that pitting or electro-etching occurred in the vicinity of the set screw marks.There was a portion of the lead not returned for analysis so a full evaluation could not take place.The high impedance report was not verified by product analysis which could be due to the whole lead not being received.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
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Search Alerts/Recalls
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