SJM Confirm™ Implantable Cardiac Monitor
CARDIOVASCULAR
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SJM Confirm

Implantable Cardiac Monitor

PRODUCT HIGHLIGHTS

  • Smallest device of its kind in both size and volume
  • Manual and auto activated triggers for EGM storage
  • Programmable data storage options to maximize episode capture
  • 3-year implant life
  • The SJM Confirm ICM can be scanned in patients under the following conditions:

-Closed bore, cylindrical magnet

-Static magnetic field strength of 1.5 Tesla (T) only

-Maximum gradient slew rate 200 T/m/s per axis -Whole body Specific Absorption Rate (SAR) less than or equal to 4.0 W/kg

-The uninterrupted duration of active scanning (when radio frequency (RF) and gradients are on) over the chest during MRI must not exceed 60 minutes

-Confirmation of absence of other contraindicated implantable devices and/or leads, including abandoned leads, lead extenders and lead adaptors


ORDERING INFORMATION

Implantable Cardiac Monitor


Reorder Number Description
DM2100 SJM Confirm ICM Model DM2100
DM2102 SJM Confirm™ ICM Model DM2102 (AF Detection)

SJM Confirm™ Implantable Cardiac Monitor (ICM)

In non-clinical testing, the St. Jude Medical™ MR Conditional SJM Confirm ICM produced a temperature rise of less than 3C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3.9 W/Kg as displayed on the MR scanner console for 60 minutes of MR scanning in a 1.5T closed bore MR scanner (manufacturer Philips, model Intera 1.5, Software version: 9.5.2). MR Conditional- Please refer to the SJM Confirm ICM User’s Manual.


Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2015 St. Jude Medical, Inc. All rights reserved.

Indications: The SJM Confirm™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias.

The SJM Confirm ICM Model DM2102 is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Contraindications: There are no known contraindications for the implantation of the SJM Confirm™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include, but are not limited to the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

SJM-CFM-1115-0007

Last Updated: January 02, 2019

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