UFM O 26MM HCIR 89MM KN 24PK
Received Apr 8, 2026 · Event occurred Mar 16, 2026
Report 0001032347-2026-00091 · MDR key 24820858
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
Biomet MicrofixationCatalog number
025-200
Lot number
N/A
Product problems
- Fracture
- Detachment of Device or Device Component
Patient
32 YR · Female
- Loss of consciousness
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5; B7; D9; G3; H3; H5; H6; H10; AND H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO THE FOLLOWING FOR 025-200: LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). THE DEVICE IS IN THE PROCESS OF BEING RETURNED FOR ANALYSIS. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD A WIRE AND DISPOSABLE PATIENT CABLE PLACED DURING AN AORTIC VALVE REPLACEMENT. APPROXIMATELY SEVEN DAYS LATER, THE PATIENT GOT UP TO GO THE BATHROOM WITH THE NURSE'S ASSISTANCE. WHEN TRYING TO GET BACK INTO BED, THE PATIENT LOST CONSCIOUSNESS. THE PATIENT'S HEART RATE WAS IN THE 30'S. THE PATIENT REGAINED CONSCIOUSNESS IN ABOUT 20 SECONDS AND CPR WAS NOT NEEDED. DUE TO THE EVENT, THE PATIENT REQUIRED EMERGENT TRANSCUTANEOUS PACING. IT WAS DISCOVERED AT THAT TIME THAT THE EPICARDIAL WIRE WAS BROKEN AT THE PIN AND NO LONGER CONNECTED. THE EMERGENT TRANSVENOUS WIRES WERE PLACED IN THE CATHETERIZATION LABORATORY.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED/CORRECTED: H6 AND H10.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.