InjuryGXZ
SUBDERMAL NEEDLE ELECTRODE
Received Feb 8, 2024 · Event occurred Jan 10, 2024
Report 1067162-2024-00002 · MDR key 18671423
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
ON (B)(6) 2024, AN INCIDENT OCCURRED WHERE A NEEDLE WAS RETAINED IN A PATIENT. THE USER RECOGNIZED THAT THE NEEDLE WAS MISSING WHEN THE ELECTRODE WAS REMOVED. THE USER ALERTED CIRCULATING STAFF AND SURGEON, THEY WERE UNABLE TO FIND IT ON THE PATIENT OR ON THE GROUND. THE SURGEON ORDERED AN X-RAY TO BE DONE OUTSIDE OF THE OR AND IT CONFIRMED THE NEEDLE WAS RETAINED. THE USER DID NOT HAVE THE BOX TO IDENTIFY THE LOT OR PART NUMBER OF THE DEVICE USED AS IT WAS DISCARDED.