MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-DWS-01

Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, due to an issue with the metal distortion levels and subsequent geometry shifts, the marshall-plan procedure originally set out to be conducted could not be performed and a pulmonary vein isolation was completed instead.Despite the issues, the pulmonary vein isolation was still completed and there were no adverse consequences to the patient.

Manufacturer Narrative

The reported event and cause could not be confirmed.Review of the ensite x cardiac mapping system voxel mode confirms that in some cases a shift can occur due to metal distortion.If a shift occurs, it is recommended to remove any metal that may be causing distortion.Additionally, use the prs setup screen to align the prss to the original location, reset the metal baseline, and/or begin a new study.

• Brand Name: ENSITE X EP SYSTEM DISPLAY WORKSTATION
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13025584
• MDR Text Key: 282398095
• Report Number: 2184149-2021-00409
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 7963641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1