It was reported that the patient had an increase in seizures for the past few months, and the patient was found to have high impedance when interrogated.She was referred for x-rays and a ct scan.The ct scan has not been sent to livanova to date.When the patient was implanted in (b)(6) 2018, their impedance was within normal limits.Ap chest x-rays were received for the patient.Based on the images provided, the pin did not appear to be through the second connector block, indicating incomplete pin insertion.The integrity of the feedthrough wires and lead wires at the connector pin appeared normal.The lead was observed in the chest.In the portions of the lead visible, no gross lead fractures or other anomalies were observed.There was a portion of the lead that appeared to be placed behind the generator with no visualization of damage.Based on the images provided, the high impedance was likely due to incomplete pin insertion.Note that the portions of the system that were not present in the images could not be assessed and the presence of micro-fractures could not be ruled out.Surgery is likely but has not occurred to date.No additional or relevant information has been received to date.
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