Electrode Pacemaker Perm Temp

FDA-Cleared Indications

• Treatment of symptomatic bradycardia requiring electrical cardiac pacing.
• Treatment of cardiac conduction disorders requiring temporary or permanent pacing.
• Pacing support for patients with clinically significant arrhythmias when prescribed by a qualified physician.

Clinical Applications

• Pacing patients with a slow heart rate caused by an inadequate cardiac rhythm.
• Providing pacing support for selected patients with heart block or other conduction abnormalities.
• Providing temporary pacing when a patient needs short-term electrical support for the heart.
• Providing permanent pacing when ongoing treatment of a clinically significant rhythm disorder is required.

Reported off-label uses

• Temporary pacing during selected cardiac procedures or while a patient is awaiting definitive treatment.
• Overdrive pacing for certain recurrent tachyarrhythmias in specialized clinical settings.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The pacing electrode and generator must be compatible with one another and with any existing cardiac hardware.
• Lead placement, fixation, connection, and testing should be performed by clinicians trained in cardiac pacing.
• The record does not establish MRI compatibility; MRI safety should be confirmed from the device-specific labeling and the complete implanted system.
• Potential contraindications and precautions include infection at the access or implantation site, inability to safely place the electrode, and lack of an appropriate pacing indication.
• Temporary and permanent pacing configurations have different handling, monitoring, and follow-up requirements.