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Indications, Safety, and Warnings

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These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms; or left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

There are no contraindications for this device.

Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during postimplant device testing should the patient require external rescue. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI scanning. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Do not use atrial-only modes in patients with heart failure. Left ventricular lead dislodgement to a position near the atria can result in atrial oversensing and left ventricular pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Do not kink, twist, or braid the lead with other leads. Do not use defibrillation patch leads with the pulse generator system. Do not use this pulse generator with another pulse generator. Ensure that Patient Triggered Monitor (PTM) is enabled prior to sending the patient home by confirming the magnet response is programmed to Store EGM. Once the PTM feature has been triggered and the magnet response set to Inhibit therapy the patient should not reapply the magnet.

For DF4–LLHH or DF4–LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead and do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not contact any other portion of the IS4–LLLL lead terminal, other than the terminal pin, even when the lead cap is in place.

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, hospital and medical environments, home and occupational environments, environmental and medical therapy hazards, follow-up testing, explant and disposal, supplemental precautionary information. Advise patients to avoid sources of EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Potential adverse events 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 (shocks /pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a puls e generator system and may experience fear of s hocking, fear of device failure, or imagined shocking. In rare cases s evere complications or device failures can occur.

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