INTELECT XT 2CH STIM
Received Aug 18, 2009
Report 1022819-2009-00173 · MDR key 1444512
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Erythema
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
THERAPIST REPORTS THAT A FEMALE PT WAS BEING TREATED FOR LOWER BACK PAIN WHEN INCIDENT OCCURRED. TREATMENT DATE WAS UNK BY THERAPIST. RED, BOIL-LIKE BURN OCCURRED DURING TREATMENT UNDER 1 ELECTRODE. TREATMENT WAS INTERRUPTED. THERAPIST WAS UNAWARE AS TO WHETHER PT SOUGHT MEDICAL INTERVENTION FOR THE BURN.
Additional Manufacturer Narrative
DEVICE IN QUESTION WAS RETURNED TO CHATTANOOGA GROUP FOR EVAL. ENGINEERING DEPT INSPECTED THE DEVICE THOROUGHLY AND TESTED DEVICE FUNCTION TO MFR SPECIFICATIONS. DEVICE PERFORMED TO SPECIFICATION. DEVICE OUTPUT WAS FOUND TO BE WITHIN LIMITS AND WAVEFORMS WERE PRODUCED CORRECTLY. NO MALFUNCTION FOUND WITH THE DEVICE. IMPROPER PT SKIN PREPARATION OR MISUSE OF THE DEVICE BY THERAPIST CAN RESULT IN ADVERSE EVENTS SUCH AS BURNS.