MAUDE Adverse Event Report: MEDTRONIC PACEART; ELECTROCARDIOGRAPH

Model Number PACEART

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported to technical services on (b)(6) 2012 that this rep is having issues importing into pace art.They did discuss that the new pace art software may not be out yet.The rep was referred to pace art for further questions.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PACEART
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17523700
• MDR Text Key: 321404024
• Report Number: MW5130648
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2012

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?: No
• Device Model Number: PACEART
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1