RLSND131-2.5
Received Oct 2, 2025 · Event occurred Sep 4, 2025
Report 1067162-2025-00006 · MDR key 23199376
Device
Generic name
Rlsnd131-2.5
Manufacturer
Rhythmlink International, LlcModel number
RLSND131-2.5Catalog number
RLSND131-2.5
Lot number
UNKNOWN
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING A POSTERIOR SPINAL FUSION PROCEDURE, A RHYTHMLINK ELECTRODE PART NUMBER RLSND131-2.5 WAS PLACED AT ERB'S POINT TO MONITOR N9 SOMATOSENSORY EVOKED POTENTIALS (SEPS) TARGETING THE BRACHIAL PLEXUS. PER STANDARD OR PROTOCOL, ALL ELECTRODES WERE COUNTED AT THE BEGINNING AND END OF THE CASE BY THE CIRCULATING NURSE. AT THE FINAL COUNT, ONE ELECTRODE WAS FOUND TO BE MISSING. AN INSPECTION OF ALL ELECTRODE PLACEMENT SITES WAS CONDUCTED IN THE OPERATING ROOM, BUT NO RETAINED ELECTRODE WAS VISUALLY IDENTIFIED. THE PATIENT WAS TRANSFERRED TO THE PACU. UPON NOTIFICATION OF THE MISSING ELECTRODE, THE SURGICAL NEUROPHYSIOLOGIST WAS SENT TO THE PACU TO RE-INSPECT ALL ELECTRODE SITES. ONE ERB'S POINT SITE, LOCATED BELOW THE CLAVICLE, APPEARED REDDENED AND SWOLLEN, THOUGH THERE WAS NO VISIBLE DISCOLORATION OR INDICATION OF A RETAINED FOREIGN BODY AT THE SKIN SURFACE. A CHEST X-RAY WAS OBTAINED, WHICH REVEALED A BROKEN ELECTRODE FRAGMENT. THE SURGEON WAS IMMEDIATELY NOTIFIED AND INITIALLY ATTEMPTED REMOVAL AT THE BEDSIDE. THIS ATTEMPT WAS UNSUCCESSFUL DUE TO THE DEPTH OF THE ELECTRODE FRAGMENT. THE PATIENT WAS THEN RETURNED TO THE OPERATING ROOM, WHERE THE RETAINED ELECTRODE WAS SUCCESSFULLY REMOVED UNDER GENERAL ANESTHESIA WITH FLUOROSCOPIC GUIDANCE. THE LOT NUMBER FOR THE ELECTRODE COULD NOT BE DETERMINED; THE REMOVED FRAGMENT WAS NOT RETAINED FOR ANALYSIS.