InjuryGXZ
UNKNOWN
Received Jun 28, 2022 · Event occurred May 30, 2022
Report 1067162-2022-00004 · MDR key 14842420
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcProduct 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 (BROKEN OFF) ELECTRODE WAS RETAINED IN THE PATIENT, AND HAD TO BE SURGICALLY REMOVED FROM THE PATIENT ABOUT 1 WEEK AFTER SURGERY. THE CUSTOMER DID NOT PROVIDE INFORMATION ON THE ELECTRODE PART NUMBER OR LOT NUMBER.