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Stratos LV/LV-T Technical Manual 3
1.3 Contraindications
Use of Stratos LV and Stratos LV-T CRT-Ps are contraindicated
for the following patients:
• Unipolar pacing is contraindicated for patients with an
implanted cardioverter-defibrillator (ICD) because it may
cause unwanted delivery or inhibition of ICD therapy.
• Single chamber atrial pacing is contraindicated for
patients with impaired AV nodal conduction.
• Dual chamber and single chamber atrial pacing is
contraindicated for patients with chronic refractory atrial
tachyarrhythmias.
1.4 Note to Physician
As with any implantable pulse generator, there are certain
infrequent risks associated with Stratos CRT-Ps. Section 1.6
lists the adverse events that have been observed or may
potentially occur with these Cardiac Resynchronization Therapy
Pacemakers. The warnings and precautions listed in
Section 1.5 should be taken under serious consideration in order
to aid in avoiding device failures and harm to the patient.
Regular monitoring of the patient and their implanted device
should be conducted to identify performance concerns and
ensure appropriate therapy is being administered to the patient.
Please communicate any performance concerns to BIOTRONIK
and to FDA.
All explanted devices should be returned to the manufacturer for
testing to help understand device reliability and performance.
Refer to Section 10 for recommended procedures for handling
explanted devices.
1.5 Warnings and Precautions
Certain therapeutic and diagnostic procedures may cause
undetected damage to a Cardiac Resynchronization Therapy
Pacemakers, resulting in malfunction or failure at a later time.
Please note the following warnings and precautions: