MAUDE Adverse Event Report: A&E MEDICAL CORPORATION UTQ 200CM BWF 2HK2F CHSO 10PK; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number	QEF2008ABW2D
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.B3 - event date - unknown day in june 2025.G2 - report source - foreign - united kingdom.
Event or Problem Description
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: b2; h1; h2; h4; 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: UTQ 200CM BWF 2HK2F CHSO 10PK
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22412552
• Report Number: 0002242056-2025-00035
• Device Sequence Number: 18636331
• Product Code: LDF
• UDI-Device Identifier: 08718627411032
• UDI-Public: (01)08718627411032(10)25426(17)270501
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: QEF2008ABW2D
• Device Lot Number: 25426
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 11/25/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown