Model Number 302-20 |
Device Problems
Corroded (1131); Fracture (1260); Therapy Delivered to Incorrect Body Area (1508); Device Contamination with Body Fluid (2317)
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Patient Problems
Pain (1994); Seizures (2063)
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Event Date 05/13/2019 |
Event Type
malfunction
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Event Description
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It was reported that high impedance with low output current was detected on the patient's generator via system diagnostics.As a result the generator was disabled on (b)(6) 2019.At the (b)(6) 2019 appointment, the patient complained of intermittent jaw pain.There were no proceeding events to explain the onset of the high impedance.No further relevant information has been received to date.No known surgical intervention has occurred ot date.
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Event Description
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Product analysis was completed on the returned generator.Analysis of the pulse generator in the pa lab found that the generator was at near end of service-yes.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.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 generator performed according to functional specifications with no anomalies identified.Product analysis was completed on the returned lead.The presence of a stress-induced lead fracture was verified at the anchor tether (bottom electrode) with corrosion present at the fracture.Corrosion indicates that stimulation was present sometime after the fracture.In addition, portions of the lead coils were exposed and making contact at an area covered with organic matter.Bodily fluid was identified within tubing with no other entrance than the tubing opening.Setscrew marks on the lead pin showed a good electromagnetic connection occurred with a generator at one point in time.No further anomalies were identified.No further anomalies identified.
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Event Description
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The suspect product (lead) and generator were received by the manufacturer, but analysis of the suspect product has not been completed to date.
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Event Description
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It was reported that after the generator was disabled due to high impedance, they experienced an increase in seizures.The patient's vns was replaced due to high impedance.The suspect product has not been received to date.No further relevant information has been received tod ate.
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Search Alerts/Recalls
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