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

Model Number 025-100

Device Problems Pacing Problem (1439); Pacing Intermittently (1443); Capturing Problem (2891)

Patient Problem No Information (3190)

Event Date 04/10/2018

Event Type  malfunction  

Event Description

Patient had a mitral valve repair, tricuspid valve repair, and cryomaze procedure and epicardial pacer wires were placed after.Temporary atrioventricular (av) pacer wires were applied at end of surgery.A 1.5 hours after arrival to cardiac surgery unit, asynchronous pacing worked intermittently, then stopped working.There was lost capture on the v wire/pacemaker.Ma was increased to 23 to obtain capture w/ voo mode.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: 7784386
• MDR Text Key: 117149652
• Report Number: 7784386
• 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: 28835 DA