inforMED
MalfunctionLDF

TEMP WIRE KITS

Received Apr 20, 2026 · Event occurred Apr 9, 2026

Report MW5186965 · MDR key 24926351

Device

Generic name

Electrode, Pacemaker, Temporary

Patient

100 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

BLOOD OR FLUID HAS BEEN BACKING UP INTO THE SWANDOM SHEATH - APPEARS AS IF THE ONE-WAY VALVE THAT GETS ATTACHED TO THE SHEATH HAS LITTLE TO NO SECURITY.