Consider device replacement if one of the following is present:
(1) All of the following
(1a) The mechanism of the malfunction is known and potentially recurrent.
(1b) A device malfunction is likely to result in death or serious harm to the patient.
(1c) The risk of replacement is less than or equal to the risk of device malfunction.
(2) The device is near the predicted end of life (EOL) and needs to be replaced anyway.
(3) The patient is pacemaker dependent.
(4) The device is an ICD that was placed for secondary prevention of sudden death.
(5) The device is an ICD that was placed for primary prevention of sudden death AND the patient has received appropriate device therapy for a ventricular arrhythmia.
Consider conservative management if:
(1) The device has been reprogrammed so that problem has been corrected or mitigated.
(2) The risk of replacement is high.
(3) The presence of one or more significant comorbid conditions that outweigh the device risk.
(4) The patient is not pacemaker dependent.
(5) The device is an ICD that was placed for primary prevention of sudden death AND the patient has not received appropriate device therapy for a ventricular arrhythmia.
