MalfunctionIPF
VECTRA GENISYS THERAPY SYSTEMS, VERSION 3.5
Received May 20, 2009 · Event occurred Feb 12, 2009
Report MW5011180 · MDR key 1392788
Device
Generic name
Stimulator, Muscle, Powered
Manufacturer
Chattanooga GroupProduct problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- Skin Discoloration
- Tissue Damage
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
INTERFERENTIAL CURRENT/ELECTRICAL STIMULATION TREATMENT WAS ADMINISTERED TO THE LOW BACK USING FOUR 2 INCH ROUND ELECTRODES IN A CRISS-CROSS PATTERN. TREATMENT WAS SET FOR 20 MIN AT STANTARD IFC SETTINGS. INTENSITY WAS ADJUSTED TO 35 VOLTS AND THEN INCREASED TO 40 VOLTS WITH REPORTED COMFORT. THE SKIN WAS CHECKED AT 5 MINUTE INTERVALS AND AFTER 10 MINUTES OF TREATMENT, BROWN HARDEN AREAS WERE NOTED UNDER THE ELECTRODES. TREATMENT WAS STOPPED.