TRANSVENOUS PACEMAKER KIT
Received Oct 28, 2025 · Event occurred Oct 9, 2025
Report MW5178171 · MDR key 23407839
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
UnknownProduct 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.