inforMED
MalfunctionIPF

E-STIM

Received May 3, 2010 · Event occurred Oct 29, 2009

Report 1677884 · MDR key 1677884

Device

Generic name

Electrical Stimulation

Model number

*

Catalog number

*

Lot number

920405

Product problems

  • Overheating of Device

Patient

64 YR

  • Burn, Thermal

Narrative

Description of Event or Problem

THE PATIENT WAS TREATED LATE LAST YEAR WITH MOIST HEAT AND ELECTRICAL STIMULATION. HE COMPLAINED IT GOT HOT AND MORE TOWELS WERE ADDED. ONE DAY FOLLOWING THE TREATMENT, PATIENT CALLED CLINIC TO REPORT HE WAS BURNED WHILE IN PHYSICAL THERAPY. ON THE THIRD DAY FOLLOWING TREATMENT, HE CALLED AND CANCELLED HIS APPOINTMENT, BUT DID NOT MENTION ANY THING ABOUT A BURN. THE PT WAS SEEN APPROXIMATELY ONE WEEK LATER. HE HAD TWO DIME SIZE AREAS IN THE LOW BACK WHERE THE ELECTRODES WERE PLACED, THAT APPEARED TO BE BURNS. NO BLISTERS OR OPEN AREAS NOTED. THE PATIENT WAS ADVISED TO FOLLOW UP WITH HIS DOCTOR.====================== HEALTH PROFESSIONAL'S IMPRESSION======================