MAUDE Adverse Event Report: A E MEDICAL CORPORATION MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	VE60WW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On routine radiograph, a temporary epicardial pacing wire was found to be fractured.Temporary cardiac pacing following cardiac surgery.

• Brand Name: MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 9852885
• Report Number: 9852885
• Device Sequence Number: 2786986
• Product Code: LDF
• UDI-Device Identifier: 08718627411711
• UDI-Public: (01)08718627411711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2020
• Report Date (Section F): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: VE60WW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/10/2020