LEGEND XT 4CH STIM
Received Apr 10, 2008 · Event occurred Mar 19, 2008
Report 1022819-2008-00108 · MDR key 1027660
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
57 YR
- Burn, Thermal
Narrative
Description of Event or Problem
CLINICIAN APPLIED ELECTROTHERAPY TREATMENT TO PT'S FOOT. THE CLINICIAN CONCLUDED THE TREATMENT WITH NO RESIDUAL TREATMENT EFFECTS. LATER AFTER THE CLINICIAN CONCLUDED THE TREATMENT THE PT REPORTED A BURN IN THE TREATMENT AREA. THE CLINICIAN TREATED THE PT USING THE PREMOD WAVEFORM. THE INTENSITY OF THE WAVEFORM WAS SET TO TOLERANCE BY THE PT. THE OUTPUT FREQUENCIES OF THE WAVEFORM WERE SET TO THE UNIT DEFAULT SETTINGS. THE TREATMENT TIME WAS PRESCRIBED TO 15 MINUTES. THE CLINICIAN APPLIED THE TREATMENT USING NEW ELECTRODES 2 INCHED IN DIAMETER. THE PT SUFFERS FROM NERVE DAMAGE IN THE FOOT OF TREATMENT. THIS WAS THE PT'S FIRST ELECTROTHERAPY TREATMENT.
Additional Manufacturer Narrative
AWAITING RETURN AND EVALUATION OF DEVICE.