InjuryGXZ
RLSND121-2.5
Received Mar 14, 2024 · Event occurred Feb 13, 2024
Report 1067162-2024-00009 · MDR key 18907282
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSND121-2.5Catalog number
RLSND121-2.5
Lot number
PM00027786
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, RLSND121-2.5, LOT PM00027786 A PAIRED NEEDLE WAS USED DURING A PROCEDURE IN WHICH STIMULATION WAS BEING APPLIED TO THE LEFT ANKLE, UPON COMPLETION OF THE STUDY THE NEEDLES WERE BEING REMOVED AND IT WAS VISUALLY IDENTIFIED THAT ONE OF THE NEEDLES REMAINED RETAINED IN THE PATIENT. THE PATIENT WAS REMOVED FROM THE OR AND AN XRAY WAS TAKEN IN PACU AND THE CLINICIAN WAS ABLE TO REMOVE THE NEEDLE FROM THE PATIENTS ANKLE WITHIN A FEW MINUTES.