inforMED

VALLEYLAB

Received Jul 11, 2014 · Event occurred Jul 8, 2014

Report 3940362 · MDR key 3940362

Device

Generic name

Electrode

Model number

*

Catalog number

E7506

Lot number

*

Product problems

  • Insufficient Device Problem Information

Patient

68 YR

  • Swelling
  • Tissue Damage

Narrative

Description of Event or Problem

THE PATIENT HAD AN ATRIAL ABLATION PROCEDURE FOLLOWED BY PERMANENT PACEMAKER INSERTION. AT THE END OF THE PROCEDURE THE TWO RETURN ELECTRODE GROUNDING PADS WERE REMOVED FROM THE BACK ABOVE THE WAIST ARE WITH SKIN DRY AND INTACT. THE NEXT DAY, THE PATIENT WAS GETTING DRESSED AND "FELT SOMETHING ON ITS BACK. THE NURSE, NURSE PRACTITIONER AND MD WAS NOTIFIED IN WHICH THERE WERE AN OPEN LESION AND CLOSED BLISTER. IT WAS TREATED WITH SILVADINE OINTMENT.