inforMED
MalfunctionJOS

DISPOSABLE GROUNDING PAD WITH CABLE

Received Apr 27, 2018 · Event occurred Feb 28, 2018

Report 7468436 · MDR key 7468436

Device

Generic name

Stimulators-automatic Nerve

Lot number

20170625

Product problems

  • Device Operates Differently Than Expected

Patient

28 YR

  • Lead(s), Burn(s) From
  • Lead(s), Burn(s) From

Narrative

Description of Event or Problem

PATIENT WAS ADMITTED FOR A RADIOFREQUENCY ABLATION OF HIS THORACIC NERVES. PRIOR TO THE PROCEDURE, A GROUNDING PAD WAS PLACED ON HIS RIGHT FLANK. THE INTEGRITY OF THE PAD WAS ASSESSED PRIOR TO PLACEMENT AS WELL AS BEFORE EACH ABLATION. THE SKIN PRIOR TO THE ABLATIONS WAS CLEAN DRY AND INTACT. THERE WAS COMPLETE CONTACT OF THE GROUNDING PAD WITH THE PATIENT'S SKIN. THERE WAS NO EXCESSIVE HAIR OVER THE AREA OF THE GROUNDING PAD. AFTER THE PROCEDURE WAS COMPLETED, THE GROUNDING PAD WAS REMOVED. IT WAS AT THIS TIME THAT 3 SMALL RED AREAS WITH A BEIGE CENTER WERE DISCOVERED. THE DOCTOR WAS NOTIFIED AND CAME TO SEE THE AREAS. THE TRAUMA BURN CLINIC WAS NOTIFIED. THE PATIENT HAS AN APPOINTMENT TO FOLLOW-UP WITH THE DOCTOR. SILVADENE CREAM WAS ORDERED BY THE DOCTOR AND ELECTRONICALLY SENT TO THE PATIENT'S PHARMACY. INSTRUCTIONS FOR USE OF THE CREAM WERE EXPLAINED TO THE PATIENT. THE RADIOFREQUENCY ABLATION MACHINE WAS SENT TO BIOMED FOR ASSESSMENT/EVALUATION. ALL SERIAL NUMBERS FOR THE PROBES HAVE BEEN DOCUMENTED AND THE PROBES WILL BE ASSESSED AS WELL. RFA MACHINE, PROBES, GROUNDING PAD AND NEEDLE CANNULA WERE SAVED AND SENT TO BIO-MED . COMPANY NOTIFIED AND ALL HAS BEEN SENT TO ST. JUDE FOR REVIEW.