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

Model Number H702496

Device Problem Impedance Problem (2950)

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Event Description

Related manufacturing ref: (b)(4).During atrial fibrillation procedures, it has been noted that more strokes are occurring than usual and it is being investigated retrospectively.It was noted that there was an attempt to export data from an ensite precision system for analysis stemming from previous impedance events during procedures.One of the things that they want to analyze is if the impedance raising are related to those events.There was no alleged issue with an abbott device.

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.The reported issue will continue to be monitored for trends and reviewed in qdr (quality data review).

• Brand Name: ENSITE¿ PRECISION¿ 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: 15866763
• MDR Text Key: 304326093
• Report Number: 2184149-2022-00282
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K183128
• 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,Followup
• Report Date: 01/18/2023

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: H702496
• Device Catalogue Number: H702496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/25/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/18/2023
• 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
• Treatment: TACTICATH 75MM US CLINICAL.