VECTRA GENISYS 4CH COMBO

Additional Manufacturer Narrative

A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNKNOWN, BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND AN 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.

Description of Event or Problem

PATIENT RECEIVED BURN DURING INTERFERENTIAL CURRENT TREATMENT FOR SHOULDER. NO PREEXISTING CONDITION REPORTED. BURN DID NOT APPEAR UNTIL AFTER PATIENT LEFT THE OFFICE. SEVERITY OF BURN NOT KNOWN. THERAPIST REPORTED THE PATIENT DID NOT SEEK FURTHER MEDICAL ATTENTION.