MalfunctionGXZ
SUBDERMAL NEEDLE ELECTRODE
Received Mar 19, 2025 · Event occurred Jan 13, 2025
Report 1067162-2025-00005 · MDR key 21645997
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, Llc.Model 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
Additional Manufacturer Narrative
NOT APPLICABLE.
Description of Event or Problem
THE CUSTOMER WAS UNABLE TO PROVIDE THE PART NUMBER OR LOT NUMBER. DURING A POSTERIOR LATERAL SPINAL FUSION (T10-L3), THE PROCEDURE WENT SMOOTHLY WITH NO IMPEDANCE ISSUES NOTED. HOWEVER, IT WAS LATER DISCOVERED THAT THE NEEDLE HAD SEPARATED AND WAS FOUND IN THE PATIENT'S SHIN. THE DEVICE WAS DISCARDED AND IS UNAVAILABLE FOR EVALUATION.