InjuryGXZ
RLSND122-2.5
Received Jun 26, 2024 · Event occurred May 15, 2024
Report 1067162-2024-00012 · MDR key 19619638
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International. LlcModel number
RLSND122-2.5Catalog number
RLSND122-2.5
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
ON (B)(6) 2024, RHYTHMLINK DEVICE RLSND122-2.5, LOT UNKNOWN WAS BEING USED DURING A OBLIQUE LUMBAR INTERBODY FUSION AND THE NEEDLE "SNAPPED OFF," THE CLINICIAN REMOVED NEEDLE WITH TWEEZERS. IT WAS REPORTED THAT THE STIMULATION LEAD WAS USED ON THE PATIENT'S ANKLE.