InjuryGXZ
RLSND121-1.5
Received Jun 26, 2024 · Event occurred May 3, 2024
Report 1067162-2024-00011 · MDR key 19619654
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSND121-2.5Catalog number
RLSND121-2.5
Lot number
PM00028655
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
ON (B)(6) 2024, RHYTHMLINK DEVICE RLSND121-1.5, LOT PM00028655 WAS USED DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION AND THE NEEDLE "SNAPPED OFF AT HUB" THE SURGEON WAS ABLE TO REMOVE THE NEEDLE. IT WAS REPORTED THAT THE STIMULATION LEAD BEING USED ON THE PATIENT'S ANKLE.