inforMED
MalfunctionDTB

MYOPORE® SUTURELESS MYOCARDIAL PACING LEAD

Received Jun 29, 2026 · Event occurred May 9, 2026

Report 2183787-2026-00042 · MDR key 25660523

Device

Generic name

Bipolar Epicardial Lead

Manufacturer

Greatbatch Medical

Model number

511211

Lot number

W2945865

Product problems

  • Failure to Capture
  • High Capture Threshold

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

LEAD SHOWED HIGH THRESHOLD AND LOSING TISSUE CAPTURE. LEAD WAS EXPLANTED.