SUBDERMAL NEEDLE ELECTRODE
Received Feb 12, 2024 · Event occurred Oct 10, 2023
Report 1067162-2024-00005 · MDR key 18692273
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
UNKNOWNCatalog number
UNKNOWN
Lot number
UNKNOWN
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
A SINGLE CUSTOMER REPORTED MULTIPLE EVENTS WHICH OCCURRED THROUGHOUT 2023, BUT WERE REPORTED TO RHYTHMLINK IN JAN 2024. ON (B)(6) 2023, SUBDERMAL NEEDLE ELECTRODES WERE USED DURING A PROCEDURE AND THE USER APPLIED A TEGADERM PATCH OVER THE ELECTRODE SITE. WHEN THE USER REMOVED THE NEEDLE ELECTRODES AND TEGADERM PATCH, THE NEEDLE ELECTRODE WAS SEPARATED FROM THE LEADWIRE AND WAS STUCK TO THE TEGADERM PATCH. THE NEEDLE WAS REMOVED WITHOUT FURTHER MEDICAL INTERVENTION, BUT IF THIS FAILURE WERE TO RECUR THE DETACHED NEEDLE COULD HAVE RESULTED IN A FOREIGN BODY IN PATIENT. THE USER DID NOT IDENTIFY THE LOT OR PART NUMBER OF THE DEVICE.