UFM W 16MM 3/8CIR 64MM KN 24PK
Report
- Report Number
- 0002242056-2023-00019
- Event Type
- Malfunction
- Date Received
- July 7, 2023
- Date of Event
- May 13, 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 SECTIONS B4, B5, G3, G6, H2, H3, H4, H6, AND H10. CORRECTIONS ARE IN SECTIONS B1, D2, D4, AND H1.
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, A5, E1, AND E3. A4:PATIENT WEIGHT: 3.166 KG ((B)(6) 2023), 3.502 KG ((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 B4, B5, D4, E1, E3, G3, G6, H2, H6 AND H10.
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.
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.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT IS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE, AND TEMPORARY PACING WIRES WERE PLACED. ATRIAL LEADS FRAYED AND FRACTURED OFF AT THE END OF THE METAL PIECE; THEREFORE, PACING WAS LOST. THE CT PHYSICIAN'S ASSISTANT (PA) STRIPPED WIRE TO DIRECTLY EXPOSE AND PLACE BACK INTO THE TEMPORARY PACEMAKER AS A TEMPORARY SOLUTION. THE PA HAD NEEDED TO STRIP FURTHER AT LEAST ONE OTHER TIME. THE VENTRICULAR LEADS ARE INTACT, BUT TENUOUS AND APPEAR AS THOUGH THEY COULD FRACTURE AT ANY POINT IN TIME. THE PERMANENT LEADS HAVE ALREADY BEEN PLACED WITH SURGICAL PLAN TO EXPOSE PERMANENT PACING LEADS AND PLACE PERMANENT PACEMAKER. THE SURGERY DATE HAS BEEN MOVED UP FOUR DAYS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1974124 | UFM W 16MM 3/8CIR 64MM KN 24PK | ELECTRODE, PACEMAKER, TEMPORARY | LDF | A&E MEDICAL CORPORATION | N/A | 03363 | 10841291100263 |
| 2056208 | 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 | 1 MO | Female | Required Intervention |