inforMED

INTELLECT LEGEND

Received Jun 26, 2009 · Event occurred Jun 12, 2009

Report 1413564 · MDR key 1413564

Device

Generic name

Electrical Stimulator

Model number

7550

Catalog number

0000

Lot number

9603

Product problems

  • Component(s), worn
  • Output, high
  • Self-Activation or Keying

Patient

45 YR

  • Muscle Spasm(s)

Narrative

Description of Event or Problem

THIS OTHERWISE HEALTHY ADULT MALE, STATUS POST FEMUR RODDING FOR FEMUR FRACTURE FROM FALL, WAS UNDERGOING ELECTRICAL STIMULATION THERAPY (AT OUR OUTPATIENT REHAB FACILITY) TO THE LEFT QUADRICEP MUSCLE. WHILE THE INTENSITY WAS BEING INCREASED BY THE PT, THE INTENSITY CONTINUED TO INCREASE INDEPENDENTLY OF THE PT PRESSING THE CONTROL BUTTON. THE DISPLAY SCREEN FLASHED AND THEN SHUT OFF. THE PATIENT NOTED A TEMPORARY INTENSE QUADRICEP CONTRACTION WITH NO REPORTED RESIDUAL EFFECTS FROM THE SURGE. THERE WAS NO DISCOLORATION NOTED TO THE AREA. THE MACHINE WAS INSPECTED BY OUR BIOMEDICAL ENGINEERING STAFF. THE UNIT WAS EVALUATED AND ALL FUNCTIONS OPERATED CORRECTLY. WE SPOKE TO THE MANUFACTURER AND WERE INFORMED THAT DAMAGED LEAD WIRES AND/OR ELECTRODES WILL CAUSE THIS PROBLEM. THE ELECTRODES WERE EXAMINED AND APPEARED TO BE WORN. THE DEVICE WAS SENT TO THE MANUFACTURER AS IT IS STILL UNDER WARRANTY. RESULTS ARE PENDING.