Solia S 45
Received Jul 31, 2026 · Event occurred Jul 15, 2026
Report 1028232-2026-03477 · MDR key 50094119
Device
Product problems
- Device Dislodged or Dislocated
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
This lead was explanted due to dislodgement. Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Combination Product: YES.Biotronik submits this report to comply with FDA regulations 21 CFR parts 4 and 803. Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by Biotronik, or its employees that the device, Biotronik, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Biotronik will submit a supplemental report if additional relevant information becomes known.