InjuryIPF
INTELCT LEGEND XT 2CH STIM
Received Apr 3, 2009
Report 1022819-2009-00085 · MDR key 1357188
Device
Product problems
- Overheating of Device
Patient
Not reported
- Burn(s)
Narrative
Description of Event or Problem
CUSTOMER STATES UNIT IS OVER HEATING AND HAS BURNED A PT.
Additional Manufacturer Narrative
THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. NUMEROUS ATTEMPTS WERE MADE TO THE CUSTOMER TO OBTAIN THE DEVICE FOR EVALUATION, INCLUDING WRITTEN NOTIFICATION. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURN BENEATH THE ELECTRODES HAVE BEEN REPORTED WITH THE USE OF POWERED MUSCLE STIMULATORS.