Biosense Webster nGEN - Adverse Reactions; Warranty; Electronic Instructions for Use

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Page 28

nGEN™ Pump User Manual

15 Adverse Reactions

A number of adverse reactions have been documented for electrophysiology procedures including:

heart block, pulmonary vein stenosis, esophageal fistula and/or injury, stroke (cerebrovascular

accident), other arrhythmias (outside diagnosis), life threatening arrhythmias, myocardial

infarction, cardiac perforation, pericardial effusion, cardiac tamponade, thrombosis, embolism,

pulmonary embolism, air embolism, valvular damage, phrenic nerve injury, vagal nerve injury,

pericarditis, coronary artery stenosis, vessel perforation (peripheral and/or central), soft tissue

injury, persistent atrial communication, device related infection, embolization of components,

device entrapment, surgical intervention (additional), skin burns, and localized skin reaction.

The following complications associated with cardiac catheterization have also been reported in the

literature:

major bleed, hematoma, reaction to medications, allergic reaction, vascular access complication,

damage to vasculature, implanted device interactions, renal artery stenosis, pneumothorax, ST

segment changes, fluid overload, urinary catheter complications, hypotension, sepsis, wound

infection, respiratory failure, heart injury, renal injury, heart failure, cardiac arrest and death.

16 Warranty

The warranty for the pump warrants that the pump will conform to its product specifications for a

period of one year from the date of installation. The warranty does not cover normal wear and tear,

damage due to improper handling, accessories, connection cables, and disposable parts. Repairs or

any changes may be performed only by Biosense Webster, a service engineer authorized by

Biosense Webster, or a service center authorized by Biosense Webster. The warranty is voided if

improper modifications or repairs are performed or if the device is not maintained according to the

instructions in this user manual. The warranty is not extended or renewed by services performed

under warranty.

17 Electronic Instructions for Use

This document is available at www.e-ifu.com.

WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.

Release Date: 2/14/2024