inforMED
MalfunctionEZM

INTERSTIM

Received Mar 3, 2009

Report 3004209178-2009-01483 · MDR key 1358044

Device

Model number

3023

Catalog number

NA

Lot number

NA

Product problems

  • Inappropriate/Inadequate Shock/Stimulation

Patient

Not reported

  • Therapeutic Response, Decreased
  • Electric Shock

Narrative

Description of Event or Problem

THE PATIENT EXPERIENCED SHOCKING / JOLTING SENSATIONS FROM HER DEVICE. TURNING THE STIMULATION DOWN RESULTED IN LOSS OF THERAPEUTIC EFFECT. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.