InjuryGXZ
RLSND121-2.5
Received Jun 10, 2022 · Event occurred May 11, 2022
Report 1067162-2022-00003 · MDR key 14654295
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSND121-2.5Catalog number
RLSND121-2.5
Lot number
PM00020288 OR PM00020061
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 CUSTOMER REPORTED THAT A TECHNICIAN REMOVED THE LEAD FROM THE PATIENT, THE NEEDLE WAS DETACHED FROM THE LEAD, AND THE NEEDLE REMAINED IN THE PATIENT'S SKIN. THE CUSTOMER STATED THE PRODUCT WAS RLSND121-2.5, BUT WAS UNSURE OF THE LOT NUMBER (PM00020288 OR PM00020061).