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

Model Number 100003063

Device Problem Signal Artifact/Noise (1036)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

During an atrioventricular nodal reentry tachycardia, there was distortion due to the ensite velocity system navlink, resulting in cancellation of the procedure.Distortion was observed on all four catheters used during the procedure.The precision electrode kit was correctly placed and connected.All cables and connections to the ep mapping and recording systems were exchanged.The procedure was stopped because it was not possible to continue due to the distortion.

Manufacturer Narrative

The lot number was confirmed to be #386310001.

Manufacturer Narrative

One ensite velocity navlink module was received for evaluation.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to a sensitive or intermittent connection at the right pin-jack location.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: ENSITE VELOCITY¿ SYSTEM NAVLINK
• 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: 19080009
• MDR Text Key: 340582918
• Report Number: 2184149-2024-00067
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K201181
• 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,Followup
• Report Date: 05/17/2024

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: 100003063
• Device Lot Number: 386310001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/15/2024; 04/30/2024
• Supplement Dates FDA Received: 05/15/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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