It was reported by a medical professional that while attempting to program a patient's device settings a message was received: "procedure failed, diagnostics failed.Unplug the programmer from power, check wand batteries and attempt again." which was indicative of a faulted system diagnostics.The programmer was unplugged from the wall outlet, but was not successful in interrogating afterwards.Upon the patient's follow-up appointment on (b)(6) 2016 she was still unable to establish communication with the generator.She performed a hard reset of the programmer and the generator was successfully interrogated.Upon interrogation the settings were reported to be "zeroed out" indicating the output currents were at zero.She was asked what the intended settings were and she stated 0.25 milliamps.She stated that she had then programmed the patient to intended output of 0.25 milliamps and interrogated the device successfully and confirmed the settings were as intended.The patient stated that since the attempt to perform diagnostics her depression had become worse, which was attributed to the settings being at zero.Additional relevant information has not been received to-date.
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