MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY CARDIAC MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100149282

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During the atrial fibrillation ablation procedure, there was a shift on the mapping system and an error message on the ampere, and the procedure was cancelled.After some ablation had been completed, the tip of the catheter appeared to fly out of the geometry on ensite, and the error message " 'amplifier error.Log out and power cycle both velocity dws and amplifier before restarting.Contact sjm technical support." was displayed.The case was cancelled, and the patient experienced no adverse consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the dhr was performed and ruled out the possibility of a manufacturing related issue causing or contributing to the reported complaint issue.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: ENSITE VELOCITY CARDIAC MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11091516
• MDR Text Key: 224252052
• Report Number: 2184149-2020-00237
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100149282
• Device Catalogue Number: EE3000
• Device Lot Number: 7495281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other