MalfunctionEZM
INTERSTIM II
Received Mar 3, 2009 · Event occurred Jan 1, 2009
Report 3004209178-2009-01486 · MDR key 1358043
Device
Product problems
- Unit inactivated
Patient
63 YR · Female
- Undesired Nerve Stimulation
- Device Overstimulation of Tissue
- Device Overstimulation of Tissue
- Pain
- Pain
Narrative
Description of Event or Problem
WHEN THE PATIENT LAID DOWN, SHE STARTED TO FEEL AN OVERSTIMULATION SENSATION AND STIMULATION IN THE WRONG LOCATION. SHE FELT PAIN IN HER VAGINAL AREA AND THOUGHT THERE WAS A "LIGHT" IN THE VAGINAL AREA AS WELL. THE DEVICE WAS TURNED OFF, BUT THE PAIN DID NOT RESOLVE. IT WAS NOTED THAT THE PATIENT WORKS IN JANITORIAL AND DOES A LOT OF BENDING AND HEAVY LIFTING. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.