RLSP503
Received May 7, 2022 · Event occurred Mar 23, 2022
Report 1067162-2022-00001 · MDR key 14320314
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSP503Catalog number
RLSP503
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
10 YR · Male
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
DURING SPINAL FUSION PROCEDURE, AN ELECTROSURGICAL UNIT (ESU) PAD WAS PLACED ON THE RIGHT POSTERIOR CALF AND LEFT POSTERIOR THIGH. NEUROMONITORING NEEDLE ELECTRODES WERE PLACED BILATERALLY ON PATIENT'S SHINS. THE LEFT POSTERIOR THIGH PAD WAS ALSO NOT ADHERING TO SKIN, SO A NEW PAD WAS PLACED ON THE LEFT POSTERIOR CALF. THE VENDOR NOTED THAT THERE WAS INTERFERENCE IN THE NEUROMONITORING FEEDBACK. A NEW PAD WAS PLACED AND RELOCATED TO UPPER RIGHT ARM. AT CASE CONCLUSION, THERE WERE BURNS NOTED AT MULTIPLE ELECTRODE SITES ON BILATERAL LOWER EXTREMITIES. THE MANUFACTURER'S EVALUATION OF AVAILABLE INFORMATION CONCLUDED THAT THE SUBDERMAL NEEDLES DID NOT GENERATE AND/OR TRANSMIT ENERGY, THEREFORE THE SUBDERMAL NEEDLES DID NOT CONTRIBUTE TO THE PATIENT BURNS.