UTQ 200CM BWF 2HK2F CHSO 10PK
Report
- Report Number
- 0002242056-2025-00037
- Event Type
- Injury
- Date Received
- July 7, 2025
- Date of Event
- June 12, 2025
- Report Date
- December 11, 2025
- Manufacturer
- A&E MEDICAL CORPORATION
- Product Code
- LDF
- UDI-DI
- 08718627411032
- PMA / PMN Number
- K033858
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
(B)(4). G2 - REPORT SOURCE - FOREIGN - IRELAND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS PRODUCT WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED/CORRECTED: B5, D4, E1, H1, H2, H4, H11 B3 - EVENT DATE - UNKNOWN DAY IN JUNE 2025 G2 - REPORT SOURCE - FOREIGN - UNITED KINGDOM.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H1; H2; H6; H11 THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO PRODUCT NOT RETURNING AND LACK OF INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.
IT WAS REPORTED THE PATIENT HAD A PACING WIRE PLACED AND PACED CORRECTLY STRAIGHT AFTER IMPLANTATION. SUBSEQUENTLY, AFTER THE PROCEDURE WHILE THE PATIENT WAS IN CICU, THE ATRIAL PACING WIRE WAS NOT CONDUCTING THE LEVELS OF ELECTRICAL CURRENT REQUIRED; HOWEVER, THE VENTRICULAR WIRE WAS WORKING CORRECTLY. FURTHER, THE WIRE COMPLETELY FAILED WHEN REQUIRED IN THE INTENSIVE CARE UNIT. THEREFORE, THE PATIENT HAD TO HAVE A PERMANENT PACEMAKER IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2768172 | UTQ 200CM BWF 2HK2F CHSO 10PK | ELECTRODE, PACEMAKER, TEMPORARY | LDF | A&E MEDICAL CORPORATION | 23562 | 08718627411032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |