InjuryIPF
INTELECT MOBILE 2 CH. STIM
Received Jan 14, 2010 · Event occurred Dec 16, 2010
Report 1022819-2009-00179 · MDR key 1579995
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Device Overstimulation of Tissue
Narrative
Additional Manufacturer Narrative
THIS DEVICE IS FOR EXPORT ONLY. COMPLAINANT STATES THAT DEVICE HAS NOT RECEIVED SOFTWARE UPDATE AS REQUIRED BY FDA RECALL. WHILE NO SERIOUS INJURY OCCURRED, POTENTIAL EXISTS FOR SERIOUS INJURY.
Description of Event or Problem
INTENSIFICATION OF ELECTRICAL STIMULATION DISCHARGE ON CHANNEL 1. WAVEFORM USED: IFC 2 POLE. TREATMENT TIME: 1 MINUTE. TREATMENT LOCATION: ARM. NO SERIOUS INJURY REPORTED.