MalfunctionEZM
INTERSTIM
Received Sep 18, 2009
Report 3004209178-2009-06670 · MDR key 1503506
Device
Product problems
- Device Stops Intermittently
Patient
Not reported
- Therapeutic Response, Decreased
Narrative
Description of Event or Problem
THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND A LOSS OF THERAPEUTIC EFFECT. SHE STATED THAT THE DEVICE HAS NOT BEEN WORKING FOR A YEAR. IT WAS ALSO STATED THAT THE PATIENT "HURT HER FOOT REALLY BAD". FURTHER INFORMATION WAS REQUESTED FROM THE HEALTHCARE PROFESSIONAL.
Additional Manufacturer Narrative
(B) (4).