CHATTANOOGA LEGEND XT 2CH STIM PKG
Received Jun 22, 2020 · Event occurred May 22, 2020
Report 9616086-2020-00021 · MDR key 10178685
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Lead(s), Burn(s) From
- Lead(s), Burn(s) From
Narrative
Additional Manufacturer Narrative
HEALTH CARE PROFESSIONAL/OCCUPATION: UNKNOWN. NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WAS BURNED ON THE LATERAL COMPONENT OF THE RIGHT KNEE DISTAL TO THE JOINT LINE WHILE ON IFC. THE INTENSITY LEVEL OF THE TREATMENT WAS NOT DOCUMENTED WITHIN THE REPORTER'S NOTES, BUT THE PATIENT HAD INDICATED THAT THE STIMULATION WAS "STRONG BUT COMFORTABLE." IT WAS REPORTED THAT THE REPORTER WAS NOT SURE WHICH ELECTRODE PADS WERE USED FOR THIS TREATMENT, BUT THEY WERE A SIZE 2 X 2. THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.