inforMED
MalfunctionDTB

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

Model number

4469

Catalog 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.