RLSND121-1.5 OR RLSND110-1.5
Received Aug 13, 2023 · Event occurred Apr 24, 2023
Report 1067162-2023-00002 · MDR key 17538112
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSND121-1.5 OR RLSND110-1.5Catalog number
RLSND121-1.5 OR RLSND110-1.5
Lot number
PM00026225 OR PM00023085
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
Additional Manufacturer Narrative
THE SAMPLE RETURNED BY THE USER CONSISTED OF A 2MM PIECE OF SKIN THAT CONTAINED BLOOD DROPS AND NO METAL FRAGMENTS WERE IDENTIFIED UNDER MAGNIFICATION. RHYTHMLINK IS UNABLE TO CONFIRM THAT THE SAMPLE RETURNED IS ASSOCIATED WITH A RHYTHMLINK DEVICE.
Description of Event or Problem
A C3-6 ANTERIOR CERVICAL DISCECTOMY AND FUSION WAS PERFORMED ON (B)(6) 2023 AND THE PROBABLE SITE WAS LEFT MED OR ULN SSEP STIMULATION IN THE CENTRAL WRIST. THE USER COULD NOT RECALL IF THERE WERE OTHER DEVICES PLACED IN THAT GENERAL LOCATION, AND THE USER DID NOT NOTICE ANYTHING OUT OF THE ORDINARY WHEN THE MONITORING WAS COMPLETE. A 2MM METAL FRAGMENT WAS REMOVED FROM THE PATIENTS VENTRAL WRIST POST-OP, AND THEN WAS EXAMINED BY THE USER FACILITY 2 WEEKS AFTER THE PROCEDURE. THE CUSTOMER COULD NOT PROVIDE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THE EVENT, BUT PROVIDED TWO (2) POTENTIAL LOTS, RLSND121-1.5 LOT PM00026225 OR RLSND110-1.5 LOT PM00023085. SINCE IT IS UNCLEAR WHICH PART NUMBER OR LOT NUMBER WAS IN USE DURING THE EVENT, WE ARE INCLUDING BOTH IN THE REPORT.