InjuryGXZ
RLSP503
Received Jan 29, 2025
Report 1067162-2025-00001 · MDR key 21263398
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Product code (GXZ)
Manufacturer (Rhythmlink International, Llc)
Model (RLSP503)
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 UNKNOWN, BUT DURING A POSTERIOR SPINAL FUSION PROCEDURE (T2-L4) LASTING 11-12 HOURS, A RHYTHMLINK DEVICE (RLSP503, LOT NUMBER UNKNOWN) WAS USED. AFTER THE REMOVAL OF THE NEEDLES, SKIN DISCOLORATION WAS NOTICED ON THE PATIENT'S SKIN, BUT NO NEEDLE WAS OBSERVED IN THE AREA. THE FOLLOWING DAY, IT WAS DISCOVERED THAT A PORTION OF THE NEEDLE HAD REMAINED IN THE PATIENT'S WRIST AREA. THE DEVICE AND NEEDLE FRAGMENT WERE DISCARDED BY THE USER FACILITY AND, AS A RESULT, COULD NOT BE RETURNED FOR EVALUATION.