InjuryGXZ
RLSND121-2.5
Received Nov 23, 2022 · Event occurred Oct 28, 2022
Report 1067162-2022-00005 · MDR key 15853703
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSND121-2.5Catalog number
RLSND121-2.5
Lot number
PM00023274
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE USER REPORTED THAT SUBDERMAL NEEDLE ELECTRODES WERE USED DURING A LUMBAR FUSION PROCEDURE. FOLLOWING PROCEDURE, USER REMOVED THE SUBDERMAL NEEDLE ELECTRODES AND DISCARDED. IN POST-OP IT WAS IDENTIFIED THAT ONE OF THE NEEDLE ELECTRODES REMAINED IN THE PATIENT'S THIGH AND WAS REMOVED WITH FORCEPS. DURING COMPLAINT INVESTIGATION, THE USER NOTED THAT THE NEEDLE APPEARED TO BE INTACT BUT DETACHED FROM THE LEADWIRE. THE PART NUMBER WAS IDENTIFIED AS RLSND121-2.5, LOT NUMBER PM00023274.