SUBDERMAL NEEDLE ELECTRODE
Received Feb 12, 2024
Report 1067162-2024-00004 · MDR key 18692143
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. DURING THE SUMMER OF 2023, PAIRED SUBDERMAL NEEDLE ELECTRODES WERE USED DURING A PROCEDURE, NEEDLE ELECTRODES WERE SECURED USING TAPE AT THE ELECTRODE SITE. WHEN THE USER WAS REMOVING THE NEEDLE ELECTRODES, THEY IDENTIFIED THAT ONE NEEDLE ELECTRODE WAS DETACHED FROM THE LEADWIRE AND THE NEEDLE REMAINED IN THE PATIENT. THE NEEDLE WAS THEN REMOVED BY THE USER WHO IDENTIFIED A DISCREPANCY WHEN DOING THE FINAL COUNT IN THE OR. THE USER DID NOT IDENTIFY THE LOT NUMBER OR PART NUMBER OF THE DEVICE.