UFM W 16MM 3/8CIR 64MM KN 24PK
Report
- Report Number
- 0002242056-2023-00020
- Event Type
- Malfunction
- Date Received
- July 7, 2023
- Date of Event
- June 3, 2023
- Report Date
- April 16, 2024
- Manufacturer
- A&E MEDICAL CORPORATION
- Product Code
- LDF
- UDI-DI
- 10841291100263
- PMA / PMN Number
- K803086
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D2: DEVICE PRODUCT CODE: LDF REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION B4, B5, G3, G6, H2, H4, H6 AND H10. CORRECTIONS ARE IN SECTIONS: A1, A2, A3, A4, E1, AND E3. A4: PATIENT WEIGHT: (B)(6)(B)(6)2023.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D2: DEVICE PRODUCT CODE: LDF. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT CANNOT BE CONFIRMED. 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. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION.
ZIMMER BIOMET COMPLAINT (B)(4). D2: DEVICE PRODUCT CODE: LDH. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION B4, B5, D4, E4, G2, G3, G6, H2, H3, H4, H6 AND H10.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT IS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE. THE METAL END OF ONE OF THE VENTRICULAR PACING WIRES FELL OFF. THE VENTRICULAR LEAD FRACTURED PRIOR TO A CODE/ECMO EVE. PATIENT CODE WAS NOT RELATED TO FRACTURED WIRE. NURSE STATED THE VENTRICULAR WIRE WAS FOR BACKUP PURPOSES. VENTRICULAR WIRE IS STRIPPED BUT NOT REPAIRED AT THIS TIME AND PATIENT DOES HAVE ATRIAL WIRES. THE VENTRICULAR WIRE PLACED FIRST, AND THE ATRIAL WIRE WAS REPLACED ABOUT TWO MONTH LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT IS FURTHER REPORTED THAT THE WIRES FRAY AND BREAK AWAY FROM THE METAL CONTACTS. PACING AND CAPTURE FAIL. THE WIRES ARE FRAGILE. THE FRAYING IS TAKING PLACE WITH IN THREE DAYS OF USE.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1974123 | UFM W 16MM 3/8CIR 64MM KN 24PK | ELECTRODE, PACEMAKER, TEMPORARY | LDF | A&E MEDICAL CORPORATION | N/A | 03363 | 10841291100263 |
| 2055256 | UFM W 16MM 3/8CIR 64MM KN 24PK | ELECTRODE, PACEMAKER, TEMPORARY | LDF | A&E MEDICAL CORPORATION | N/A | 03363 | 10841291100263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO | Male | Required Intervention |