It was reported that during initial implant procedure on (b)(6) 2017, the pulse generator exhibited rf telemetry lockout.A sterile wand was used to interrogate the device instead.On (b)(6) 2017, the patient presented in clinic for follow up and upon interrogation, the device exhibited backup vvi operation and displayed an error message.The device was reprogrammed and resumed normal functions.Upon successful interrogation, low impedance and loss of output was noted.It was suggested that the device battery was prematurely depleted.On (b)(6) 2017, the device was explanted and replaced successfully.The patient was asymptomatic throughout the event.
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