MAUDE Adverse Event Report: MEDTRONIC PASEART SYSTEM; ELECTROCARDIOGRAPH

Model Number PACEART

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A call to technical services on 12/30/11 states that they did a save to disk, put the disk in and they use paceart and can't get it to come through on paceart.They do have the latest version of paceart and they have downloaded it in the past.The data is there on the disk, nothing populates at all in paceart.Ts verified again that they have the correct path in paceart.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PASEART SYSTEM
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17521546
• MDR Text Key: 321375276
• Report Number: MW5128494
• 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: 02/02/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: PACEART
• Patient Sequence Number: 1