RLSND123-2.5 OR RLSND124-2.5
Received Jan 16, 2026 · Event occurred Dec 1, 2025
Report 1067162-2026-00002 · MDR key 24099175
Device
Generic name
Rlsnd123-2.5 Or Rlsnd124-2.5
Manufacturer
Rhythmlink InternationalModel number
N/ACatalog number
RLSND123-2.5 OR RLSND124-2.5
Lot number
PM00035941 OR PM00037915
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
N/A.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IN (B)(6) 2025, A NEEDLE ELECTRODE WAS PLACED IN THE ABDUCTOR HALLUCIS (AH) MUSCLE OF THE FOOT. UPON REMOVAL, THE NEEDLE WAS OBSERVED TO BE BROKEN. THE RETAINED FRAGMENT WAS IMMEDIATELY IDENTIFIED AND SUCCESSFULLY RETRIEVED. NO ADDITIONAL MEDICAL INTERVENTION OR PATIENT CARE WAS REQUIRED, AND NO PATIENT INJURY WAS REPORTED. THE SPECIFIC PART NUMBER AND LOT NUMBER USED DURING THE PROCEDURE WERE NOT AVAILABLE. HOWEVER, THE REPORTER IDENTIFIED TWO POTENTIAL RHYTHMLINK PART NUMBERS, RLSND123-2.5 AND RLSND124-2.5, AND TWO POSSIBLE LOT NUMBERS, PM00035941 AND PM00037915.