SJM Confirm™ Implantable Cardiac Monitor Model DM2100
CARDIOVASCULAR
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SJM Confirm™

Implantable Cardiac Monitor Model DM2100

PRODUCT HIGHLIGHTS

  • Implantable, patient-activated and automatically activated monitoring system that records subcutaneous ECGs and is indicated in the following cases:

– Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

– Patients who experience transient symptoms that may suggest a cardiac arrhythmia

  • Offers simple-to-configure data storage options to enable physicians to prioritise data based on individual patient conditions, ensuring capture of significant events and to reduce the risk that unexpected events are missed
  • Comprehensive diagnostic data reports provide a quick and accurate summary of heart rate, assisting physicians in their diagnosis and treatment of the patient’s condition
  • The small 6.5 cc size of the SJM Confirm ICM DM2100 is designed to reduce the risk of infection during the implant procedure by requiring a smaller incision and a smaller subcutaneous pocket. A small device footprint may also reduce implant time and means less change in body image for patients
  • The proven St. Jude Medical SenseAbility™ feature is designed to allow accurate sensing over a wide range of signals, specifically offering more sensitive QRS detection

ORDERING INFORMATION

Contents: Implantable Cardiac Monitor


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc)
DM2100 56.3 x 18.5 x 8 12 6.5 (± 0.5)

Separately Available Accessories

Reorder Number Description
DM2100A Patient Activator Model DM2100A

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.

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.

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.

Item GMCRM910EN

Last Updated: January 02, 2019

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