MalfunctionDBT
ELOX EX 60-BP
Received Feb 13, 2026 · Event occurred Dec 3, 2025
Report 1028232-2026-00779 · MDR key 24338910
Device
Product problems
- Failure to Capture
Patient
Not reported
- Syncope/Fainting
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS DELIVERED TO HOSPITAL WITH SYNCOPE DUE TO LOSS OF CAPTURE. A NON-CAPTURE EVENT WAS OBSERVED IN THE PAST, AFTER A GENERATOR CHANGE. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Additional Manufacturer Narrative
COMBINATION PRODUCT: YES.