MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 3; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-PRSBACK-01

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

During a ventricular tachycardia ischemic procedure, a clinically significant delay occurred due to a prs-p sensor slightly displacing and not being able be reversed.After multiple troubleshooting efforts, as the automark function was working properly during ablation and the slight movement of the prs-p sensor did not cause significant anatomy displacement, the procedure was able to be completed.There were no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.Review of the device history record was not possible as the lot number is unknown.

• Brand Name: ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 3
• 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: 13690573
• MDR Text Key: 287194208
• Report Number: 2184149-2022-00059
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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 Assistant
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-PRSBACK-01
• Device Catalogue Number: ENSITE-PRSBACK-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2022
• 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