It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results showed high impedance (dc dc ¿ 7).The patient¿s device was subsequently disabled.Diagnostic results two weeks prior to the high impedance observation showed lead impedance within normal limits.No trauma was reported to have occurred and the patient¿s seizures were well-controlled.X-rays were taken and were reported by the physician to be unremarkable.X-rays dated (b)(6) 2014 were provided to the manufacturer for further review.The generator appears in the left chest in a normal placement.The filter feed-through wires appear to be intact.The lead connector pin cannot be confirmed to be fully inserted into the generator connector block.Part of the lead was behind the generator and could not be assessed.No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.Based on the images provided, the cause of the high lead impedance remains unknown.Follow-up revealed that the patient underwent surgery on (b)(6) 2014.The lead pin was reinserted into the generator header and diagnostic results show lead impedance within normal limits.The patient¿s device was not programmed on during the procedure.
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