InjuryGXZ
RLSP503
Received Jan 29, 2025
Report 1067162-2025-00002 · MDR key 21263584
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, Llc.Model number
RLSP503Catalog number
RLSP503
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 IS UNSPECIFIED. DURING A CAROTID ENDARTERECTOMY, A RHYTHMLINK DEVICE (RLSP503, LOT NUMBER UNKNOWN) WAS USED, AND IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE LEADWIRE AND WAS LEFT IN THE PATIENT'S ARM. THE NEEDLE WAS DISCOVERED AFTER CLOSURE AND WAS REMOVED USING TWEEZERS. IMAGES WERE TAKEN TO CONFIRM THAT NO FRAGMENTS OF THE NEEDLE REMAINED.