Contraindications
There are no contraindications for the CRT-D device. Use of LV leads is contraindicated in patients with a hypersensitivity to a nominal dose of 0.45, 0.7 or 1.0 mg dexamethasone acetate drug. Some LV lead models are contraindicated in patients with mechanical tricuspid heart valves, or obstructed or inadequate vasculature for intravenous catheterization.
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. Program the pulse generator Tachy Mode to Off during implant, explant or postmortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator protection available during implant. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient’s death. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant 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 device scanning. Strong magnetic fields may damage/interfere with the device and lead system and cause injury to the patient. Do not subject a patient with an implanted pulse generator and lead system to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. Do not use atrial-only modes in patients with heart failure because such modes do not provide CRT. LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. Do not use defibrillation patch leads with the CRT-D system, or injury to the patient may occur. Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction resulting in patient injury or lack of therapy delivery. For specific models, when using a subpectoral implantation, place the pulse generator with the serial number facing away from the ribs. Implanting the pulse generator subpectorally with the serial number facing the ribs may cause repetitive mechanical stress to a specific area of the titanium case, potentially leading to a component failure and device malfunction.
When using a RV pace/sense lead in conjunction with an LV pacing lead, it is recommended that a polyurethane-insulated lead be used. Failure to observe this warning could result in insulation damage of the RV lead, which can cause a periodic or continual loss of pacing, sensing or both. Lead fracture, dislodgment, abrasion or an incomplete connection can cause a periodic or continual loss of pacing, sensing or both. The use of battery-powered equipment is recommended during lead implantation and testing to protect against fibrillation that might be caused by leakage currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. The lead connector must be insulated from any leakage currents that could arise from line-powered equipment. The lead is not designed to tolerate excessive flexing, bending, tension or injection pressure. This could cause structural weakness, conductor discontinuity or lead dislodgment. When using a finishing wire accessory kit, use the corresponding finishing wire model for the lead length If the wrong length finishing wire is used, the finishing wire tip may extend out of the distal end of the lead or not stabilize the lead properly. When placing the lead with a stylet, use only a stylet designed for use with the ACUITY Steerable lead. These stylets are specifically designed to prevent the stylet from extending past the lead tip. Extending the stylet past the lead tip may cause tissue damage.
Precautions
For information on precautions, refer to the following sections of the PG product labeling: clinical considerations, sterilization, storage and handling, implant and device programming, follow-up testing, explant and disposal, environmental and medical therapy hazards; hospital and medical environments; 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-D 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 (shocks/pacing/sensing), infection, procedure related, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management/imagined shocking, 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.
Product Type
Cardiac Resynchronization Therapy
Used in Procedures
Cardiac Resynchronization Therapy ImplantationRelated Medical Areas
Cardiac Rhythm ManagementRelated Conditions
Heart Conditions
