inforMED
MalfunctionLDF

ELECTRODE, PACEMAKER, TEMPORARY

Received Jun 30, 2026 · Event occurred Jun 8, 2026

Report 2024168-2026-02586 · MDR key 25669280

Device

Generic name

Electrode, Pacemaker, Temporary

Model number

401675

Catalog number

401675

Lot number

9104053

Product problems

  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H6 MEDICAL DEVICE PROBLEM CODE: 2017 - USE AFTER EXPIRATION. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT AN EXPIRED PACEL CATHETER WAS ACCIDENTALLY USED IN VIVO. THERE WERE NO PATIENT ADVERSE CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE.