MAUDE Adverse Event Report: A AND E MEDICAL CORPORATION MYO/WIRE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 025-100

Device Problems Pacing Problem (1439); Pacing Asynchronously (1441); Capturing Problem (2891)

Patient Problem No Information (3190)

Event Date 04/18/2018

Event Type  malfunction  

Event Description

Temporary atrioventricular (av) pacer wires were applied during coronary artery bypass graft (cabg).Two hours after cabg, the epicardial pacer had intermittent failure to capture and patient needed urgent temporary transvenous pacemaker placement.Wires would only pace at a very high ma (~20 ma), then after some time would only asynchronously pace, then stopped working completely.Cable connectors and pacer boxes as well as batteries were switched out to help troubleshoot.

• Brand Name: MYO/WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A AND E MEDICAL CORPORATION; 5206 asbury rd.; farmingdale NJ 07727
• MDR Report Key: 7784484
• MDR Text Key: 117158440
• Report Number: 7784484
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 025-100
• Device Lot Number: 0709A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA