RLSND121-1.5
Received Feb 27, 2025 · Event occurred Jan 24, 2025
Report 1067162-2025-00003 · MDR key 21477365
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSND121-1.5Catalog number
RLSND121-1.5
Lot number
PM00033184
Product problems
- Fracture
- Detachment of Device or Device Component
- Fracture
- Detachment of Device or Device Component
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
NOT APPLICABLE.
Description of Event or Problem
RHYTHMLINK PART NUMBER: RLSND121-1.5, LOT: PM00033184, WAS USED DURING A RETROSIGMOID CRANIOTOMY FOR MICROVASCULAR DECOMPRESSION OF THE TRIGEMINAL NERVE. THE PATIENT WAS POSITIONED SUPINE WITH TWO CHEST ROLLS PLACED UNDER HER LEFT SIDE, ROTATING HER 30 DEGREES. THE NEEDLE WAS INSERTED UP TO THE HUB AND PLACED AT THE ANKLE FOR PTN STIMULATION DUE TO EDEMA. NEEDLES WERE POSITIONED AT A 30-45 DEGREE ANGLE. THE PROCEDURE LASTED 6-7 HOURS, AND UPON REMOVAL, IT WAS NOTED THAT THE DISTAL NEEDLE WAS MISSING AND APPEARED SHEARED.