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

Model Number	ENSITE-SRFLNK-01
Medical Device Problem Codes	Signal Artifact/Noise (1036); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Udi related data quality updates only.Additional information: d4, g3, g6, h2, h11.
Additional Manufacturer Narrative
Correction: d4, h2, h11.

• Brand Name: ENSITE¿ X SURFACELINK MODULE
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18358456
• Report Number: 2184149-2023-00244
• Device Sequence Number: 18146370
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: (01)05415067033611(21)841770001-23(10)841770001
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 841770001
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 02/02/2024; Not provided; 07/09/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/14/2024; 06/19/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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