INTELECT LEGEND COMBO 4C

Description of Event or Problem

THE PATIENT WAS BEING TREATED FOR KNEE PAIN USING THE INTERFERENTIAL ELECTROTHERAPY WAVEFORM WHEN THE PATIENT REPORTED FEELING A JOLT FROM THE APPLIED TREATMENT. THE INTENSITY OF THE JOLT WAS SIGNIFICANT AND PROMPTED THE PATIENT TO IMMEDIATELY REMOVE THE TREATMENT ELECTRODES. THE INTERFERENTIAL WAVEFORM WAS CONFIGURED TO 40%, WITH A TREATMENT TIME OF 20 MINUTES, AND AN INTENSITY OF 5-7MA. THE TREATMENT WAS APPLIED USING SELF-ADHESIVE 2X2 INCH ELECTRODES. COLD THERAPY WAS BEING USED IN CONJUNCTION WITH THE ELECTROTHERAPY TREATMENT. THE PATIENT'S TREATMENT WAS INTERRUPTED WITH NO INJURY, AND PROGRESS TOWARDS RECOVERY WAS NOT IMPEDED. THE PATIENT HAD TAKEN THREE ELECTROTHERAPY TREATMENTS PER WEEK AT AN INTENSITY OF 13-15MA PRIOR TO THIS EVENT. THE THERAPIST REPORTED THAT THE DEVICE DISPLAY APPEARED TO BE GARBLED AND UNREADABLE AFTER THE INCIDENT. THE DEVICE WAS CHECK BY THE BIOMEDICAL DEPARTMENT, POST-INDECENT, AND WAS REPORTED THAT THE CHANNEL OUTPUTS WOULD OVER-CURRENT DURING MEASUREMENT. THE ELECTRODES ARE USED FOR 2-3 TREATMENTS OR UNTIL THERE IS A SIGNIFICANT DECREASE IN HYDRATION (STICKINESS).

Additional Manufacturer Narrative

A DEVICE EVALUATION WAS PERFORMED BY OUR SERVICE DEPARTMENT. ROOT CAUSE IS UNKNOWN BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE SERVICE DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS.