LEGEND XT
Received Jul 15, 2009 · Event occurred Jun 12, 2009
Report 1022819-2009-00162 · MDR key 1415074
Device
Product problems
- Insufficient Device Problem Information
Patient
75 YR
- Burn, Thermal
Narrative
Description of Event or Problem
A MALE PATIENT WAS BURNED WHILE BEING TREATED WITH A LEGEND XT MUSCLE STIMULATOR USING INTERFERENTIAL CURRENT (IFC). THE BURNS WERE REPORTED TO THE HEALTHCARE PROVIDER FOLLOWING THE TREATMENT. THE HALF INCH SIZE BURNS WERE DESCRIBED AS SIMILAR TO CIGARETTE BURNS, AND HAD FORMED BENEATH THE ELECTRODES AT FOUR POINTS AROUND THE KNEE. THE DEGREE OF BURN COULD NOT BE CONFIRMED.
Additional Manufacturer Narrative
IN 2009, A COMPLAINT WAS REPORTED BY TELEPHONE. THE HEALTH CARE PROFESSIONAL REPORTING THE COMPLAINT, STATED A MALE PATIENT WAS BURNED WHILE BEING TREATED WITH A LEGEND XT MUSCLE STIMULATOR USING INTERFERENTIAL CURRENT (IFC). THE BURNS WERE REPORTED TO THE HEALTHCARE PROVIDER FOLLOWING THE TREATMENT. THE HALF INCH SIZE BURNS WERE DESCRIBED AS SIMILAR TO CIGARETTE BURNS, AND HAD FORMED BENEATH THE ELECTRODES AT FOUR POINTS AROUND THE KNEE. THE DEGREE OF BURN COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED FOR EVALUATION TWO WEEKS LATER, WITHOUT THE INCIDENT ELECTRODES AND LEAD WIRES. ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE. THE DEVICE IS INCLUDED IN THE ONGOING STIM-BOARD RECALL. HOWEVER, THE DEVICE ARRIVED WITH THE CORRECTED SOFTWARE VERSION 2.9. THE IFC WAVEFORM PERFORMED TO SPECIFICATION. TESTS CONDUCTED ON THE DEVICE REVEALED NO ANOMALIES. ELECTRODE SIZE, TYPE, USAGE, AND CONDITION PLAY AN IMPORTANT PART IN THE PROPER DELIVERY OF ELECTROTHERAPY. THE ELECTRODES CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTING FACTOR. IN ADDITION, PATIENT SKIN PREPARATION, ELECTRODE PLACEMENT AND/OR THE EXPERIMENTAL PROCEDURES REPORTED DURING THE INVESTIGATION MAY BE A CAUSE OR CONTRIBUTING FACTOR.