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

Model Number	ENSITE-SRFLNK-01
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the surfacelink had an output issue which resulted in a cancellation of the procedure.While the patient was prepped, there was an amplifier error on ensite x system displaying "surface electrode impedance error.Confirm original surface electrode placement".Attempts at troubleshooting included reboots of the amplifier and dws, surface electrode replacement twice, and a 12-lead replacement.The procedure was aborted due to lack of mapping and the anatomy was considered too difficult to pursue a fluoroscopy and ice only procedure.The issue was resolved by replacing the surfacelink.
Additional Manufacturer Narrative
One ensitex surfacelink module was received for evaluation.Based on the information and investigation provided to abbott, the root cause was isolated to an open electrical circuit.The ensite x surfacelink module was sent to triage for disposition.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the output issue and subsequent cancellation were identified.

• Brand Name: ENSITE¿ X SURFACELINK MODULE
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19986543
• Report Number: 2184149-2024-00138
• Device Sequence Number: 4551597
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: (01)05415067033611(10)9130445
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K231415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: ENSITE-SRFLNK-01
• Device Catalogue Number: ENSITE-SRFLNK-01
• Device Lot Number: 9130445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown