A report was received indicating that a vns patient who underwent a full system revision on (b)(6) 2016 was in the intensive care unit on (b)(6) 2016 with bradycardia every five minutes, suspected to be related to vns stimulation.The patient's treating neurologist was at the hospital and elected to disable the device output.The physician ran system diagnostics and found readings within normal limits (lead impedance of 1,647 ohms).The physician indicated she would leave the device outputs off over the weekend and then try titrating the patient up from a low starting point on monday (b)(6) 2016.Follow up indicated that the device output was re-enabled on (b)(6) 2016 at an output current of 0.25ma with no bradycardia events observed.It was stated that the patient has never experienced bradycardia with vns therapy over the 12 years he has had vns therapy.The device had previously been set to an output current of 1.75ma in the operating room at the time of generator replacement on (b)(6) 2016.This is lower than the patient's setting with his prior device (2.25ma), however, prior to the replacement surgery the patient's device had been turned off 3-4 weeks due to a low lead impedance condition with the prior vns system (reported in mfg rpt#1644487-2016-00958).Normal lead impedance values were observed via system diagnostics on (b)(6) 2016.The provider states that one possible cause of the newly observed bradycardia could be the re-instatement of vns therapy after approximately a year of not receiving intended stimulation due to the prior lead issue and the device disablement.The provider stated the other potential causes may be that the new lead electrodes may have been placed near the cardiac branch of the vagus nerve, or that the vagus nerve may have been ""raw"" (irritated) due to the lead revision surgery.The patient was discharged on (b)(6) 2016.On (b)(6) 2016 the patient was seen and device output currents were increased by the provider with no patient issues.Diagnostic values were within normal limits including lead impedance.The physician plans to continue a gradual titration of the patient on a bi-weekly basis.
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