It was reported that a patient's device was showing high impedance and limited output current delivered.It was stated that the physician could not see any lead breakage on the x-ray.The patient reported occasional pain around the generator site and an increase in seizures.From follow-up on the patient's seizures, it was stated that the patient's seizures were controlled, but suddenly began increasing again.The pain was reportedly random and infrequent.Lead revision surgery occurred, and it was stated that the surgeon had cut the lead and placed the new lead electrodes above the old electrodes which were left in place.Images of the explanted lead showed abraded openings and what appeared to be bodily fluid along multiple portions of the outer tubing.It was unclear based on the quality of the images if the inner tubing was compromised.It was reported that the explanted lead was not available to be returned to the manufacturer for analysis.No device was returned to date.No additional, relevant information has been received to date.
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