VECTRA GENISYS 2CH COMBO
Received Jun 19, 2009 · Event occurred Apr 22, 2009
Report 1022819-2009-00154 · MDR key 1406218
Device
Product problems
- Power Conditioning Problem
Patient
61 YR
- Electric Shock
- Hospitalization required
Narrative
Description of Event or Problem
PATIENT TREATED FOR BILATERAL SHOULDER PAIN. FIFTEEN MINUTE INTERFERENCIAL CURRENT ELECTROTHERAPY TREATMENT. TREATMENT SURGED AN SHOCK OCCURRED. TREATMENT INTENSITY WAS TURNED DOWN AND TREATMENT WAS CONTINUED ON LEFT SHOULDER BUT NOT RIGHT SHOULDER. PATIENT REPORTED GOING TO ER. ER TESTS WERE NEGATIVE.
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 ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SHIN IRRITATION AND BURNS BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS.