INTELECT XT 4 CHANNEL COMBO
Received Aug 3, 2009 · Event occurred Sep 1, 2007
Report 1022819-2009-00171 · MDR key 1438896
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Tissue Damage
Narrative
Description of Event or Problem
THERAPIST REPORTED TO CHATTANOOGA GROUP THAT IN 2007, A PT REPORTED THAT AFTER TREATMENT FOR NUMBNESS OF HIS LEFT LEG, A LARGE WOUND FORMED. THE THERAPIST DID NOT SEE OR TREAT THE WOUND, BECAUSE THEY STATE THAT THE FACILITY WAS NOT MADE AWARE OF THE ISSUE UNTIL MONTHS AFTER THE INCIDENT.
Additional Manufacturer Narrative
THE UNIT ASSOCIATED WITH THIS INCIDENT WAS RETURNED TO CHATTANOOGA GROUP FOR EVAL AND TESTING. ENGINEERING DEPT PERFORMED FULL FUNCTIONAL TESTS AND FOUND NO ISSUES WITH THE DEVICE. ENGINEERING STATES THAT THE UNIT PASSED ALL TESTS CONDUCTED, NO ANOMALIES WERE FOUND, AND THAT THE UNIT MEETS ALL MFRS SPECIFICATIONS. DUE TO THE TIME LAPSE FROM THE INCIDENT (2007) AND THE TIME THAT THE INCIDENT WAS REPORTED TO CHATTANOOGA GROUP (JUN 2009) INVESTIGATIONS INTO THE INCIDENT CANNOT DETERMINE THE SEVERITY OF THE WOUND, RECOVERY OF THE PT, OR POSSIBLE ROOT CAUSES STEMMING FROM MISUSE OR IMPROPER TREATMENT.