Brief Statement
Indications
9526 Reveal® Plus Insertable Loop Recorder
The Reveal Plus ILR is an implantable patient- and automatically
activated monitoring system that records subcutaneous ECG and is
indicated for
- Patients with clinical syndromes or situations at increased
risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a
cardiac arrhythmia
6191 Activator
The Model 6191 Activator is intended for use in combination with
a Medtronic Model 9526 Reveal Plus Insertable Loop Recorder.
Contraindications
There are no known contraindications for the implantation of the
Reveal Plus ILR. However, the patient’s particular medical condition
may dictate whether or not a subcutaneous, chronically implanted device
can be tolerated.
Warnings/Precautions
9526 Reveal Plus Insertable Loop Recorder
Patients with the Reveal Plus ILR should avoid sources of magnetic
resonance imaging, diathermy, high sources of radiation, electrosurgical
cautery, external defibrillation, lithotripsy, and radiofrequency
ablation to avoid electrical reset of the device, and/or inappropriate
sensing.
6191 Activator
Operation of the Model 6191 Activator near sources of electromagnetic
interference, such as cellular phones, computer monitors, etc.,
may adversely affect the performance of this device.
Potential Complications
Potential complications include, but are not limited to, body tissue
rejection phenomena, including local tissue reaction, infection, device
migration and erosion of the device through the skin.
2090 Programmer
The Medtronic/Vitatron CareLink programmer system is comprised
of prescription devices indicated for use in the interrogation and
programming of implantable medical devices. Prior to use, refer
to the Programmer Reference Guide as well as the appropriate programmer
software and implantable device technical manuals for more information
related to specific implantable device models. Programming should
be attempted only by appropriately trained personnel after careful
study of the technical manual for the implantable device and after
careful determination of appropriate parameter values based on the
patient's condition and pacing system used. The Medtronic/Vitatron
CareLink programmer must be used only for programming implantable
devices manufactured by Medtronic or Vitatron.
See the device manual for detailed information
regarding the implant procedure, indications, contraindications,
warnings, precautions, and potential complications/adverse events.
For further information, please call Medtronic at 1-800-328-2518
and/or consult Medtronic’s website at www.medtronic.com.
To learn more about syncope, visit www.fainting.com.
Caution: Federal law (USA) restricts this device
to sale by or on the order of a physician.
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