Zoom USB External Manual do Utilizador descarregar pdf (Página 5)

ADDENDUM TO: 002-1362, Rev. D, US

Most Current Brief Summaries found @ www.

http://www.bostonscientific.com/

CRT-P System from Boston Scientific – Contak Renewal

Indications

The CONTAK RENEWAL TR pulse generator is 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). These 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. For single patient use only Do not reuse, reprocess, or resterilize. Such damage can result in

patient injury or death. Do not expose a patient to MRI device scanning. Do not expose a patient with an activated implanted pulse generator to diathermy. Do not use atrial-only modes in patients with

heart failure. 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 dualchamber 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 specific 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. 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 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. M)

CRT-P Systems from Boston Scientific - INVIVE

Indications

The Invive cardiac resynchronization therapy pacemaker (CRT-Ps) is 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 pharmacologic therapy for heart failure. Atrial tracking modes are also indicated for patients who may benefit from

maintenance of AV synchrony. Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in physical

activity.

Contraindications

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. For single use only. Do not reuse, reprocess or resterilize. Always have external defibrillation

protection available during implant and electrophysiologic testing. Do not use this pulse generator with another pulse generator. In response to applicable nonrecoverable or repeat fault conditions, the

pulse generator will switch irreversible to Safety Core operation. Do not kink, twist, or braid leads. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Do not use

atrial only modes in patients with heart failure. In devices with the lead safety switch programmed to On, the lead polarity will switch to unipolar in the presence of a lead impedance of ≤ 200 or ≥ 2000 Ω. If

programmed to a fixed atrial sensitivity value of 0.15 mV, the pulse generator may be more susceptible to electromagnetic interference. Advise patients to seek medical guidance before entering

environments that could adversely affect the operation of the active implantable medical device. Do not expose a patient to MRI scanning. Do not subject a patient with an implanted pulse generator

and/or lead to diathermy. Left ventricular (LV) lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition.

Precautions

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization and storage; implantation; device programming; environmental and

medical therapy hazards; hospital and medical environments ; home and occupational environments; follow up testing; explant and disposal; and supplemental precautionary information. Advise patients

to avoid sources of electric or magnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Potential Adverse Events

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. A)

ICD Systems from Boston Scientific – PUNCTUA, ENERGEN, and INCEPTA

ICD Indications and Usage

PUNCTUA

, ENERGEN

, and INCEPTA

ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular

arrhythmias.

Contraindications

Use of these ICD systems are contraindicated in: Patients whose ventricular tachyarrhythmias may have reversible cause, such as 1) digitalis intoxication, 2) electrolyte imbalance, 3) hypoxia, or 4)

sepsis, or whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. Patients who have a unipolar pacemaker.

Warnings

Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system. For single patient use only. Do not reuse, reprocess, or resterilize. Program the pulse

generator ventricular Tachy Mode to Off during implant, explant or post-mortem procedures. Always have external defibrillator protection available during implant and electrophysiologic testing. Ensure

that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing. Patients should 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 to diathermy. Do not use atrial tracking modes in patients with chronic refractory atrial

tachyarrhythmias. Do not use this pulse generator with another pulse generator. Do not kink, twist or braid lead with other leads. For Patient Triggered Monitor (PTM) feature, make sure the feature is

enabled prior to sending the patient home with a magnet. Once the PTM feature has been triggered and the magnet response programming is 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.

Precautions

medical therapy hazards; hospital and medical environments; home and occupational environments follow-up testing; explant and disposal; supplemental precautionary information. Advise patients to

avoid sources of electromagnetic interference (EMI).

Potential Adverse Events

Potential adverse events from implantation of the ICD 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.

(Rev. B)