InjuryLDF
ELECTRODE, PACEMAKER, TEMPORARY
Received Jun 25, 2026 · Event occurred Jun 2, 2026
Report 2024168-2026-02522 · MDR key 25623217
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Abbott Vascular Inc.Model number
401771Catalog number
401771
Lot number
10360663
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Perforation of Vessels
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE PROCEDURE WITH A PACEL BIPOLAR PACING CATHETER, A PERFORATION WAS OBSERVED. INTERVENTION WAS PERFORMED TO RESOLVE THE PERFORATION. NO FURTHER INFORMATION WAS AVAILABLE.
Additional Manufacturer Narrative
B3: THE ESTIMATED PROCEDURE DATE IS (B)(6) 2026. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.