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CRT-P Systems from Boston Scientific CRM

Indications
Cardiac resynchronization therapy pacemakers (CRT-Ps) are indicated for patients who have moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥ 120 ms and remain symptomatic despite stable, optimal heart failure drug therapy (as defined in the clinical trials section in the System Guide). The devices provide atrial-ventricular tracking modes to help preserve AV synchrony and adaptive-rate pacing for patients who would benefit from adjusted pacing rates concurrent with physical activity.

Contraindications
These devices are contraindicated in patients who have a separate implanted cardioverter-defibrillator (ICD). Single-chamber atrial pacing is contraindicated in patients with impaired AV nodal conduction. Atrial tracking modes are contraindicated for patients with chronic refractory atrial tachyarrhythmias (atrial fibrillation or flutter), which might trigger ventricular pacing. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.

Warnings
Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. Such damage can result in patient injury or death. Do not kink the leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Do not expose a patient with an activated implanted pulse generator to diathermy. Therapeutic diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pacemaker because of induced currents. Do not use atrial-only modes in patients with heart failure because such modes do not provide CRT. The clinical outcomes for patients with chronic refractory atrial tachyarrhythmias are not fully known. Safety and effectiveness studies have not been conducted. If a chronic refractory atrial tachyarrhythmia develops in a patient with these devices, do not use dual-chamber or single-chamber atrial pacing. Left ventricular (LV) lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition.

Precautions
For information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization, storage and handling; implantation and device programming; pulse generator explant and disposal; environmental and medical therapy hazards; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Potential Adverse Events
Potential adverse events from implantation of the CRT-P system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (pacing/sensing), infection, lead tip deformation and/or breakage, procedure related, and component failure. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events. Rx only.
(Rev. I)