It was reported that the patient developed an infection and experienced on and off fever.The patient also reported experiencing swelling, pain, and hot to the touch sensation at the implant pocket of the implantable cardioverter defibrillator.The source and date the infection developed was not determined.However, it was noted that the patient had an atrial lead replacement completed on the (b)(6) 2020.An echocardiogram was completed which revealed there was vegetation on the old atrial lead.On (b)(6) 2020, the entire implantable cardioverter defibrillator system was removed successfully.The patient was reported to be in stable condition.Related manufacturer reference number: 2017865-2020-15934, 2017865-2020-15935, 2017865-2020-15936.
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