Medtronic DDMC3D1 Technical Manual

Medical Procedures and EMI Precautions

for MR Conditional Implantable Cardiac Defibrillators

Manual for Health Care Professionals

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1 Medical procedures and EMI precautions

1.1 Introduction

This manual is intended for physicians and other health care professionals who treat patients who have an
implanted Medtronic cardiac defibrillator (ICD). To view this manual online, to download it, or to see the latest list
of device models to which this manual pertains, refer to the Medtronic Manual Library at
www.medtronic.com/manuals.

Section 1.2 of this document is useful to health care professionals who perform medical procedures on patients
with Medtronic cardiac pacing systems and who consult with the patients’ cardiologists. This section provides
warnings, precautions, and guidance related to medical therapies and diagnostic procedures that may cause
serious injury to a patient, interfere with the system, or permanently damage the system. Some common medical
procedures that pose no risk are also listed.

Section 1.3 provides precautions and other information related to electromagnetic interference (EMI) that is helpful
to patients in their daily living. Health care professionals can review the information with their patients and use it as
a reference for post-implant consultations.

For additional guidance on medical procedures or potential EMI scenarios you are concerned about that are not
addressed in this manual, customers can contact the following resources:

●

Customers in the United States can contact Medtronic Technical Services at [phone]. You may also
submit questions to [e-mail] or your Medtronic representative.

●

Customers outside of the United States can contact a Medtronic representative.

1.2 Warnings, precautions, and guidance for clinicians performing medical procedures on cardiac device patients

Ablation (RF ablation or microwave ablation) – Ablation is a surgical technique in which radio frequency (RF)

or microwave energy is used to destroy cells by creating heat. Ablation used in cardiac device patients may result
in, but is not limited to, induced ventricular tachyarrhythmias, oversensing, unintended tissue damage, device
damage, or device malfunction. Pulse-modulated ablation systems may pose higher risk for induced ventricular
tachyarrhythmias. Medtronic cardiac devices are designed to withstand exposure to ablation energy. To mitigate
risks, observe the following precautions:

●

Ensure that temporary pacing and defibrillation equipment is available.

●

Avoid direct contact between the ablation catheter and the implanted system.

●

Position the return electrode patch so that the electrical current pathway does not pass through or near the
device and lead system.

●

Always monitor the patient during ablation with at least two separate methods, such as arterial pressure
display, ECG, manual monitoring of the patient’s rhythm (taking pulse) or monitor by some other means such
as ear or finger pulse oximetry, or Doppler pulse detection.

To avoid or mitigate the effects of oversensing, consider the following precautions:

●

Suspend tachyarrhythmia detection by using a magnet or a programmer. If a programmer is used and ablation
causes a device reset, the cardiac device resumes detection. After the ablation procedure, remove the magnet
or restore device parameters.

●

If appropriate for the patient, program the device to an asynchronous pacing mode (for example, DOO). After
the ablation procedure, restore device parameters.

Capsule endoscopy, pH capsule procedures – Capsule endoscopy is a procedure in which a capsule
containing a tiny camera is swallowed by the patient to take pictures of the patient’s digestive tract. Capsule
endoscopy and pH capsule procedures should pose no risk of electromagnetic interference.

Dental procedures – Dental equipment, such as ultrasonic scalers, drills, and pulp testers, poses no risk of
electromagnetic interference. Keep a cardiac device at least 15 cm (6 in) away from magnets, such as magnets
found in dental office pillow headrests.

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