Meridian and Discovery Pacemaker Systems

• 8 recalls, same reason

  • Terminated Z-1033-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031
  • Terminated Z-1034-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031
  • Terminated Z-1036-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031
  • Terminated Z-1038-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031
  • Terminated Z-1035-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031
  • Terminated Z-1039-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031
  • Terminated Z-1032-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031
  • Terminated Z-1037-05 FDA Unclassified (pre-2012) ·initiated 18 Jul 2005 ·on shared PMA P940031

  A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade name

Vigor(Tm) Dr Pacemaker System

Generic name

implantable pacemaker Pulse-generator

PMA number

P940031 ↗

FDA product code

DXY

Device class

Class III

Regulation

21 CFR Part 870.3610

Advisory committee

Cardiovascular

FDA decision

APPR Approved

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• Are the Meridian and Discovery Pacemaker Systems reusable, or are they intended for single-use implantation only?

  The Meridian and Discovery Pacemaker Systems are designed for **single-use implantation only**. Once implanted surgically under sterile conditions, they are not intended to be removed or reused. This aligns with standard practice for implantable pulse-generators to prevent infection risks and ensure patient safety.

• What types of patients are these pacemaker systems intended to help, and how do they work?

  These systems are designed for patients with **bradycardia (slow heart rate) or conduction system disorders**, where the heart fails to maintain an adequate rhythm on its own. They work by delivering **electrical impulses** to the heart muscle via leads, ensuring a consistent and appropriate heartbeat to support proper cardiac function.

• How are these devices supplied, and what precautions should be taken during handling?

  The Meridian and Discovery Pacemaker Systems are supplied **sterile** and require **specialized training** for implantation and follow-up management. Since they are implanted surgically, sterile techniques must be strictly adhered to during handling to prevent contamination and ensure patient safety.

• What regulatory pathway was followed for approval of these pacemaker systems?

  These devices received **FDA_PMA authorization**, which is the regulatory pathway for Class III medical devices requiring a Premarket Approval application. The approval process includes a thorough review by the FDA’s **Cardiovascular (CV) Advisory Committee**, ensuring compliance with strict safety and efficacy standards for implantable pacemakers.