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

Technical services received a call on (b)(6) 2012.Caller stated that they were unable to load data into paceart from a usb.Caller was sent to paceart.No additional information is available at this time.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: 17531430
• MDR Text Key: 321384569
• Report Number: MW5138345
• 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

• 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