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

Model Number EE3000

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an atrial fibrillation procedure, respiratory compensation was done on the prs, but no magnetic points for map creation were used.Early in the procedure the map started to shift up and anterior, making ablation difficult.There were no adverse patient consequences.There was a clinically significant delay due to this issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned, however the software files were returned for evaluation.Review of the ensite cardiac mapping system verifies that in some cases a shift can occur.Catheter display shift is consistent with any number of the following: patient re-positioning such as upper limb motion and displacement of the chest or abdomen, positional reference electrode dislodgement and patch connection, adhesion, or placement issues.Non-transient shifts can be related to the gravitational shift of body weight as the patient relaxes during the procedure and subsequent gradual impedance changes in the body.Powering up or shutting down other lab equipment can cause electromagnetic interference with the abbott equipment.In addition, changing connections to other lab equipment such as a stim generator can cause catheter shift.If a shift occurs, it is recommended to use enguide alignment to return the catheters to their previous positions relative to the model.Based on the information provided and the investigation performed, the cause of the reported event remains unknown.

• Brand Name: ENSITE VELOCITY CARDIAC MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11019075
• MDR Text Key: 221742932
• Report Number: 2184149-2020-00213
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: 100014514
• Device Lot Number: 5634326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other