MalfunctionIPF
LEGEND XT 4CH STIM PKG US STD
Received Jun 27, 2022 · Event occurred Jun 1, 2022
Report 9616086-2022-00016 · MDR key 14837167
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Superficial (First Degree) Burn
- Superficial (First Degree) Burn
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE THE UNIT ALLEGEDLY CAUSED A 1ST DEGREE BURN TO PATIENT DURING STIM TREATMENT. AFTER PERFORMING FUNCTIONAL AND ELECTRICAL TESTING, THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. THE PRODUCT MET MANUFACTURER SPECIFICATIONS. POSSIBLE ROOT CAUSES INCLUDE MOISTURE OR MISAPPLICATION OF THE ELECTRODES.
Description of Event or Problem
IT WAS REPORTED THAT THE THE UNIT ALLEGEDLY CAUSED A BURN TO PATIENT DURING STIM TREATMENT.