InjuryGXZ
RLSND121-2.5
Received Sep 11, 2024
Report 1067162-2024-00013 · MDR key 20189567
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, Llc.Model number
RLSND121-2.5Catalog number
RLSND121-2.5
Lot number
PM00031540
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
DATE OF EVENT UNKNOWN, RHYTHMLINK DEVICE RLSND121-2.5, LOT NUMBER PM00031540 WAS BEING USED DURING A POSTERIOR CERVICOTHORACIC FUSION C2-T4. PROCEDURE LASTED 7 HOURS 15 MINUTES AND UPON REMOVAL IT WAS DISCOVERED THAT THE ELECTRODE IN THE RIGHT ANKLE DETACHED FROM THE BLACK HUB OF THE NEEDLE ASSEMBLY. IMAGING OCCURED IN POST OP AND DID NOT REVEAL THE RETAINED FRAGMENT, FRAGMENT WAS NOT LOCATED.