InjuryGXZ
SUBDERMAL NEEDLE ELECTRODE
Received Feb 13, 2024
Report 1067162-2024-00008 · MDR key 18699715
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
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A SINGLE CUSTOMER REPORTED MULTIPLE EVENTS THAT OCCURRED THROUGHOUT 2023, WHICH WERE REPORTED TO RHYTHMLINK INTERNATIONAL IN (B)(6) 2024. THE CUSTOMER STATED THAT SUBDERMAL NEEDLE ELECTRODES HAVE BEEN FOUND BROKEN IN THE PACKAGE OR BEFORE INSERTION INTO THE PATIENT, AND THE DEVICE WAS NOT USED AND PUT IN A SHARPS CONTAINER. THE USER DID NOT IDENTIFY THE DATE OF THE EVENT, THE PART NUMBER, OR THE LOT NUMBER OF THE SUBDERMAL NEEDLE ELECTRODE.