MEDTRONIC - 4504M

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Steroid Tip(Tm) Model 4503&4003 Transvenous Pacing

Generic Name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

PMA Number

P830061 ↗

FDA Product Code

NVN

Models / Variants

4003M

4503M

4504M

4523 Pacing

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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  FDA PMA P900061 Active Approved 11 Feb 1993

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  FDA PMA P030036 Active Approved 3 Aug 2005

See all devices from Medtronic Cardiac Rhythm Disease Management →

• What specific cardiac chambers are these pacemaker electrodes designed to be implanted in, and how do they differ in function between those chambers?

  These electrodes are designed for implantation in either the **right ventricular (RV)** or **right atrial (RA)** chambers. The primary function remains pacing stimulation to regulate bradycardia or conduction disorders, but the placement differs: RV electrodes target the lower heart chamber to stimulate ventricular contractions, while RA electrodes target the upper chamber to stimulate atrial contractions. Both models feature a **steroid-eluting tip** to reduce tissue inflammation and improve electrode stability, ensuring consistent pacing regardless of chamber placement.

• Are these electrodes reusable, or are they intended for single-use only? What does this mean for clinical workflows?

  These electrodes are **intended for single-use only** and are supplied sterile for implantation by qualified healthcare professionals. This design ensures patient safety by eliminating risks associated with reuse, such as infection or degradation of electrode performance. Clinically, this means each electrode must be opened and used immediately in a controlled setting like a cardiac catheterization lab or operating room, with proper disposal following use.

• What storage requirements must be followed to maintain sterility and functionality of these electrodes?

  The electrodes must be stored according to **manufacturer guidelines** to preserve sterility and functionality. Since they are supplied sterile, they should remain in their original packaging until ready for use, protected from contamination, moisture, or physical damage. Exposure to extreme temperatures or prolonged storage beyond the specified shelf life could compromise performance, so adherence to the packaging instructions is critical.

• How do the steroid-eluting tips on these electrodes benefit patients compared to non-steroid-eluting models?

  The **steroid-eluting tip** reduces tissue inflammation at the implantation site, which helps minimize fibrosis (scarring) around the electrode. This improves long-term electrode stability and pacing consistency, reducing the likelihood of lead dislodgment or failure over time. For patients, this can translate to fewer complications and a lower risk of requiring reoperation or lead revision.

• What should clinicians consider regarding MRI compatibility when using these electrodes?

  The **MRI compatibility** of these electrodes is **not specified** in the provided data. Clinicians should consult Medtronic’s official guidelines or documentation for the specific models (4003M, 4503M, 4504M, or 4523) before exposing patients to MRI scans. If MRI is required, alternative imaging modalities or precautions may need to be taken to avoid potential risks to the patient or device.