MAUDE Adverse Event Report: MEDTRONIC PACEART; ELECTROCARDIOGRAPH

Model Number PACEART

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A call to technical services on 3/17/2011 states that when the rep entered this device into paceart, it came up in red as if it was on an advisory.The device is not on any advisories.No other information is available.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: 17517910
• MDR Text Key: 321290966
• Report Number: MW5124858
• 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: 04/07/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: PACEART
• Patient Sequence Number: 1