SUBDERNAL NEEDLE ELECTRODE
Received Dec 19, 2025
Report 1067162-2025-00008 · MDR key 23854224
Device
Generic name
Subdernal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
UNKNOWNCatalog number
UNKNOWN
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
THE DATE OF THE EVENT AND THE PART AND LOT NUMBERS ARE UNKNOWN. DURING A 9.5-HOUR T2-PELVIS POSTERIOR SPINAL FUSION, PAIRED 22 MM SUBDERMAL NEEDLES WERE USED IN ALL FOUR LIMBS AND THE NECK, WITH SPACING OF APPROXIMATELY 1-2 INCHES IN THE LIMBS AND ABOUT 5 INCHES IN THE NECK. ALL NEEDLES WERE INSERTED UP TO THE BLACK HUB, AND THE NEEDLE OF INTEREST WAS PLACED AT THE RIGHT POSTERIOR KNEE TO MONITOR THE RIGHT PERONEAL NERVE. AT BREAKDOWN, IT WAS OBSERVED THAT THE NEEDLE ASSOCIATED WITH THE GREEN LEAD HAD BROKEN OFF FROM THE BLACK HUB. THE DETACHED NEEDLE WAS IDENTIFIED WHEN THE DRAPES WERE REMOVED AND THE IOM TECHNOLOGIST ATTEMPTED TO REMOVE IT. DURING BREAKDOWN, THE PATIENT WAS NOTED TO BE SWEATY, AND THE RIGHT LEG HAD FALLEN OFF THE SURGICAL TABLE. DESPITE THESE OBSERVATIONS, NO SIGNIFICANT NEUROMONITORING CHANGES WERE NOTED DURING THE PROCEDURE..