inforMED
MalfunctionLDF

TRANSVENOUS PACEMAKER KIT

Received Oct 28, 2025 · Event occurred Oct 9, 2025

Report MW5178171 · MDR key 23407839

Device

Generic name

Electrode, Pacemaker, Temporary

Manufacturer

Unknown

Product problems

  • Patient Device Interaction Problem

Patient

81 YR · Female

  • Discomfort
  • Fluid Discharge
  • Discomfort
  • Fluid Discharge

Narrative

Description of Event or Problem

AT THE BEGINNING OF AM SHIFT, POST ASSESSMENT AND DURING ULTRASOUND OF VESSEL MAPPING, I NOTICED LARGE DRAINAGE PRESENT IN STERILE SLEEVE OF TRANSVENOUS WHITE TUBING GOES THRU FOR PACEMAKER CABLE CENTRAL LINE. RIGHT FEMORAL TRANSVENOUS PACEMAKER WAS INSERTED BY DR. (B)(6), CARDIOLOGIST, (B)(6) 2025 AROUND 16:52 APPROXIMATELY PER DOCUMENTATION IN CATH LAB FOR A STEMI. DR. (B)(6) NOTIFIED RIGHT AWAY IN CATH LAB. HE WAS DOING A PROCEDURE. SPOKE TO CATH LAB RN AND MADE HER AWARE OF SITUATION. AROUND 9:44 DR. (B)(6) NOTIFIED AGAIN WITH TEXT AND PICTURE OF TRANSVENOUS PACEMAKER, IT'S MAKING PT UNCOMFORTABLE WITH SOME PRESSURE TO THE SITE POST ULTRASOUND AT THE BEDSIDE. AFTER 10 AM, CATH LAB STAFF ARRIVED AND SHORTLY AFTER, DR. (B)(6) TO FOLLOW. HE THEN PROCEEDED TO DRAIN THE FLUID INSIDE AND CHANGE DRESSING AT BEDSIDE WITH CAT LAB STAFF. PT FELT COMFORTABLE AFTER PROCEDURE AND VSS THROUGHOUT.