MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X SURFACELINK MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SRFLNK-01

Device Problems Signal Artifact/Noise (1036); Impedance Problem (2950)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

At the start of the atrial fibrillation case, impedance errors resulted in a procedural delay.When disconnecting a lead from the module, the issue resolved and the procedure was completed with no adverse consequences to the patient.A patch impedance error was noted on the system and there was no ecg (purple lines).A new system reference patch was tried, ecg gel was applied to the patch, and the patient was re-patched, but the issue persisted.When disconnecting the right leg lead from the surfacelink, the signals returned on ensite x.The procedure was delayed, and the physician felt that it was clinically significant.The procedure was completed without adverse consequences for the patient.

Manufacturer Narrative

One ensitex surfacelink (surflink) module was received for evaluation.Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to an electrical open to the active belly patch pin from an undetermined event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances associated with the reported event were identified.

• Brand Name: ENSITE¿ X SURFACELINK MODULE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18358456
• MDR Text Key: 331108366
• Report Number: 2184149-2023-00244
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: 05415067033611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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: ENSITE-SRFLNK-01
• Device Lot Number: 841770001
• 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: 12/08/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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