On (b)(6) 2015 it was reported that the patient¿s vns was interrogated and found to be at end of service with pulse disabled as well as high impedance during diagnostics.Surgery took place that day and when the generator was replaced, high impedance was still observed.Therefore they did a full revision.There was no noticeable lead fracture but the electrodes were in an inverted position.It was reported that the explanted products could not be returned for product analysis as the hospital discards them.
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