FDA Adverse Event Malfunction Summary report: N

OMNISTIM 3020

MDR report key: 1342568 · Received February 23, 2009

Report

Report Number
1342568
Event Type
Malfunction
Date Received
February 23, 2009
Date of Event
November 10, 2008
Report Date
February 23, 2009
Manufacturer
PHYSIO TECHNOLOGY INC.
Product Code
GZJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
OH, US

Narratives

Description of Event or Problem · 1

PATIENT WAS GOING TO RECEIVE ELECTRICAL STIMULATION TO THE LEFT LOWER LUMBAR/LEFT UPPER HIP AREA. HIS SKIN WAS CLEANED WITH ALCOHOL AND ALLOWED TO DRY PRIOR TO ELECTRODE PLACEMENT. ELECTRODES WERE PLACED AND LEADS PLACED PRIOR TO TURNING UNIT ON. PHYSICAL THERAPIST TURNED ALL INTENSITY KNOBS OFF PRIOR TO TURNING THE POWER ON THE UNIT ON. UNIT WAS TURNED ON AND TIMER WAS TURNED ON. PRIOR TO INTENSITY KNOBS BEING TURNED ON, PATIENT REPORTED SHARP SHOCK UNDER THE UPPER ELECTRODE AREA ON LEFT LUMBAR/UPPER HIP AREA. POWER WAS IMMEDIATELY DISCONTINUED AND ELECTRODES WERE CHECKED TO MAKE SURE THEY WERE STILL ATTACHED. ELECTRODES WERE ALL INTACT AND IN PLACE (NOT PULLED OFF). PHYSICAL THERAPIST INSPECTED THE AREA AND NO SKIN ALTERATIONS IN COLOR NOTED. ALL SKIN WAS INTACT AND WITHIN NORMAL LIMITS. PHYSICAL THERAPIST QUESTIONED PATIENT REGARDING THE PAIN. HE STATED THAT IT WAS A SHARP SHOCK BUT HAD NO FURTHER CONTINUED PAIN OUTSIDE OF HIS USUAL PAIN. PATIENT WAS ADVISED TO OBSERVE THE AREA OVER THE NEXT DAY OR SO AND NOTIFY PHYSICAL THERAPIST IF ANY CHANGES ARE NOTED. PHYSICAL THERAPIST CONTINUED WITH HEAT ONLY TO THE SAME AREAS (LEFT LUMBAR/LEFT HIP) WITH EXTRA PADDING FOR 20 MINUTES. PHYSICAL THERAPIST AGAIN CHECKED SKIN AND NORMAL ERYTHEMA WAS NOTED WHERE HEAT WAS APPLIED. PATIENT REPORTED NO FURTHER PAIN IN ELECTRODE AREA PRIOR TO LEAVING THE DEPARTMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OMNISTIM 3020 STIMULATOR, NERVE, TRANSCUTANEOUS GZJ PHYSIO TECHNOLOGY INC. * *

Patients

Seq Age Sex Outcome Treatment
1 46 YR