InjuryIPF
INTELECT XT 2CH COMBO
Received Jun 19, 2009
Report 1022819-2009-00151 · MDR key 1404757
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Arrhythmia
- Skin Discoloration
- Discomfort
Narrative
Description of Event or Problem
INTERFERENTIAL FREQUENCY (PRESENT PROTOCOL) WAS SET FOR 15 MINUTES TO THE RIGHT SI/GLUTEUS REGION. APPROX. 2 MINUTES INTO TREATMENT INTENSITY DOWN FOR PATIENT COMFORT. UPON REMOVAL OF ESTIM PADS, ARRYTHMIA AND A PENCIL ERASER SIZED WHITE CALLOUSED-LOOKING AREA OBSERVED UNDER MOST SUPERIOR POSITIONED ELECTRODE (DISTO-LATERAL TO RIGHT PSIS).
Additional Manufacturer Narrative
AWAITING RETURN AND EVALUATION OF THE DEVICE. INVESTIGATION FINDINGS WILL BE PROVIDED UPON DEVICE EVALUATION CONCLUSION.