Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problem
Seizures (2063)
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Event Date 09/02/2014 |
Event Type
malfunction
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Event Description
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It was reported that the patient moved states and has not been seen by a physician in 8 months.The patient reported that he feels a sensation in his chest area and is experiencing an increase in seizures.The patient was seen by a physician and device diagnostics resulted in high impedance (dc dc code - 7).The patient was referred to surgeon.The patient underwent generator and lead replacement (including electrodes).The explanted lead and generator were received for analysis.Analysis is underway, but has not been completed 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.
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Event Description
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Analysis of the returned generator and lead was completed.There were no anomalies found with the pulse generator.The generator performed according to functional specifications.Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in the electrode region.Some of the broken coil strands was identified as having pitting.Pitting was observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The abraded opening found on the outer silicone tubing and the cut ends made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.
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Manufacturer Narrative
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Device failure occurred, but did not cause or contribute to death.
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Search Alerts/Recalls
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