It was reported that the patient was seen in an appointment on (b)(6) 2016.At the beginning of the appointment, the generator had settings on a sensitivity level of 3 and threshold of 40%.Autostimulations were noted in the office visit data.The sensitivity setting was attempted to be lowered to values of 1 and 2, but heartbeat was not detected.After placing the sensitivity setting back to 3, the heartbeat was unable to be verified.The output currents were not programmed off prior to attempting to detect the heart rate.The heartbeat verification was reportedly completed successfully in the implant surgery of the generator.The generator dhr was reviewed and found all specifications were met prior to distribution.The review of operations in the dhr showed the generator was a mechanically routed device.No additional pertinent information has been received to date.
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