Model Number 102 |
Device Problem
High impedance (1291)
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Patient Problem
Seizures (2063)
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Event Date 03/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Event Description
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It was reported that a patient had high impedance.The patient was having an increase in seizures.The patient's x-rays were examined, which indicated that the pin was not fully inserted into the generator.The patient's physician believes the increase in seizures is due to the high impedance.Surgery is likely but has not occurred to date.No additional or relevant information has been received.
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Event Description
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Generator analysis was completed and approved.The generator output signal was monitored for more than 24 hours, placed in a simulated body temperature environment and showed no signs of variation in the output signal.The device showed it was able to provide the expected level of output current for the entire monitoring period.The generator diagnostics were expected for the programmed settings.The connector block and header lead pin cavity passed all functional testing, the generator had expected diagnostic test results for convertor codes at various load resistances, and the septum cavity passed dimensional evaluation.Photo of returned set screw revealed indentions on the bottom of the screw indicating tightening to the lead pin or test resistor.The device performed according to functional specifications of the current automated final test and analysis in the lab concluded proper functionality of the pulse generator and that no abnormal performance of any other type of adverse condition was found.
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Event Description
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The patient¿s generator was explanted due to high impedance and worsening seizures.X-rays showed pin was dislodged from header and patient had generator replaced.The surgeon did not reinsert the pin into the model 102 because we had already planned to upgrade to the model 106.Generator was received for analysis.Analysis is underway but has not been completed to date.No additional or relevant information has been received to date.
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Event Description
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Current programming history was received and reviewed for the patient.No additional or relevant information has been received to date.
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Search Alerts/Recalls
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