FINELINE II EZ Sterox
Received Jul 30, 2026 · Event occurred Jul 16, 2026
Report 2124215-2026-40815 · MDR key 50078588
Device
Generic name
Implantable Lead
Manufacturer
Boston Scientific CorporationModel number
4469Catalog number
4469
Lot number
632572
Product problems
- Failure to Capture
Patient
81 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that this right atrial (RA) lead exhibited loss of capture (LOC). Technical Services (TS) was consulted and reviewed the electrogram (EGM), noting that the patient was experiencing atrial fibrillation (AF). TS indicated that the apparent loss of capture was likely due to atrial tissue being refractory during AF. TS further noted that there was no evidence that paced events contributed to the rhythm. Right atrial automatic threshold (RAAT) tests measurements were found to be stable. TS provided troubleshooting recommendations. This RA lead remains in service. No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.