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

Model Number	ENSITE-SRFLNK-01
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the supraventricular tachycardia procedure, there was a delay due to the ensite x surfacelink module missing a pin.The patches were not able to be connected.The patches were replaced, the ensite x amplifier was rebooted, and the ensite x dws was rebooted, but the issue persisted.The ensite x surfacelink was replaced, and the issue was resolved.Upon inspection, it was noted that the ensite x surfacelink was missing a pin.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.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 physical damage 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
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT 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: 23650619
• Report Number: 2184149-2025-00189
• Device Sequence Number: 17349358
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: (01)05415067033611(10)930810001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202066
• 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): 01/07/2026

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: 930810001
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown