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

Model Number ENSITE-SYSTEM-01

Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Communication or Transmission Problem (2896)

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

The cause of the reported communication issues was not able to be determined as the compact disc needed to investigate the event was not returned.For the reported event of electrical interference, review of the ensite system shows that adjusting the metal environment near the patient, such as raising the flat detector, may resolve the issue.If necessary, resetting the metal baseline should resolve the issue.The software was noted to be functioning as designed.For the reported mapping issue, collecting more voxels when entering a new area, such as a vein, will help increase the validity of the catheter.The catheter visualization changes depending on the density of voxels surrounding each catheter.When the density of voxels is low, the catheter will show in a low confidence state.When the density of voxels is high, the catheter will show in a high confidence state.The software was noted to be functioning as designed.

Event Description

Related manufacturer ref: 2184149-2021-00387.During a paroxysmal atrial fibrillation ablation procedure, mapping, error messages, electrical interference, and communication issues occurred that caused a clinically significant delay.Despite the issues and troubleshooting that was attempted to resolve them, the procedure was still successfully completed with no adverse consequences to the patient.

• Brand Name: ENSITE¿ X EP SYSTEM
• 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: 13010232
• MDR Text Key: 282270534
• Report Number: 2184149-2021-00386
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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