MAUDE Adverse Event Report: MEDTRONIC PASEART SYSTEM; ELECTROCARDIOGRAPH

Model Number PACEART

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A call to technical services on 8/10/2011 states that health care provider is working with sales rep trying to upload device disk to paceart.Caller already called medtronic paceart tech support who used livemeeting and stated that the disk data was in an incorrect format.Disk seems to have the correct data.Conferenced paceart to help troubleshoot the upload of disk data to paceart.After troubleshooting with paceart support it was determined that the pc caller was using did not have the latest paceart getconnected 3 software installed.Once this was updated, the device upload occurred without issue.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: 17533334
• MDR Text Key: 321186576
• Report Number: MW5140238
• 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: 09/01/2011

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