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

Model Number VE60WW

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2020

Event Type  malfunction  

Event 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
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 9852885
• MDR Text Key: 184120038
• Report Number: 9852885
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 08718627411711
• UDI-Public: (01)08718627411711
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: VE60WW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1