Model Number 302-20 |
Device Problems
Corroded (1131); Fracture (1260); Mechanical Problem (1384)
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Patient Problem
Seizures (2063)
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Event Date 12/22/2017 |
Event Type
malfunction
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Event Description
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It was reported that high impedance was identified on the patient¿s device.The patient had been having more violent behavior, which may have been sub-clinical seizures, for the previous three weeks.Swiping the magnet did seem to help with the violent behavior.No further relevant information has been received to date.
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Manufacturer Narrative
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Corrected data, explant date - the explant date was inadvertently omitted from the initial report.
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Event Description
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The patient had full revision surgery due to high impedance.The generator and lead were received, but analysis has not been approved to date.
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Event Description
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Analysis on the generator was approved.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified.The device output signal was monitored, and results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis on the lead was also approved.Abraded openings were noted on the outer and the inner silicone tubing.A break was identified in the positive coil.Scanning electron microscopy images of the positive coil (including strand segments) shows that pitting or electro-etching conditions have occurred at the break location and at the discolored surface.Also, the positive coil show that a stress-induced fracture has occurred in at least two strands of the quadfilar coil.However, due to mechanical distortion (smoothed surfaces), surface contamination and/or metal dissolution the fracture mechanism on others strands cannot be ascertained.Scanning electron microscopy images of the negative coil verified that pitting or electro-etching conditions have occurred at the suspected area.Note that since a portion of the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.No other anomalies were identified in the returned lead portions.
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Search Alerts/Recalls
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