MalfunctionIPF

INTELLECT LEGEND XT VERSION 3.8

Received May 20, 2009 · Event occurred Feb 5, 2009

Report MW5011179 · MDR key 1392787

Device

Generic name

Stimulator, Muscle, Powered

Manufacturer

Chattanooga Group

Product problems

Unknown (for use when the device problem is not known)

Patient

UNK

Erythema
Painful stimulation
Tissue Damage

Narrative

Description of Event or Problem

ESTIM (INTERFERENTIAL) 80/150 FREQUENCY (PRESENT PROTOCOL) WAS SET FOR 15 MINUTES TO THE RIGHT SI/GLUTEUS REGION. INTENSITY SET TO PT'S TOLERANCE IN A SITTING POSITION. APPROX 2 MINUTES INTO TREATMENT INTENSITY DOWN FOR PT COMFORT. UPON REMOVAL OF E-STIM PADS, ERYTHEMA AND A PENCIL ERASER-SIZED WHITE CALLOUSED-LOOKING AREA OBSERVED UNDER MOST SUPERIOR POSITIONED ELECTRODE (DISTO-LATERAL TO RIGHT PSIS).