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

Model Number	ENSITE-SRFLNK-01
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At the beginning of an atrial flutter procedure, signal issued occurred which caused procedure delay.No signals were seen when connected to the ensite x 20-pin cim.It was noted that the signals were displayed for a short time, but then disappeared.Troubleshooting included connecting the cim to port 7, 8, and 4, but issue persisted.The non-abbott (ge) recording system had managed to get signals without any issues and the catheter was able to be visualized on the ensite x system.Changing the pin from 1 to 11 made the signals noisy.Tech support had advised to switch to the 80-pin cim, but the same issue was still seen.Further troubleshooting included checking the rl drive, shutting off the non-abbott (ge) amplifier, doing a full reboot, and starting a new case with the existing patient.After validation was achieved, a surface electrode impedance error was displayed but replacing the system reference did not resolve the issue.Another attempt was made to reboot the amplifier and revalidate but the error continued to persist, and the ecg signals were still lost.The case was paused for about an hour to get another surface link from a neighboring hospital and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One ensitex surfacelink (surflink) module was received for evaluation.The module was recognized upon connecting to a test station.Evaluation testing revealed that the surflink primary active patch did not produce an expected signal.The voltage readings measured at the (right leg or neutral) electrocardiogram (ecg) electrical pin verified the electrical pin was (intermittent) partially-functional.This pin duplicates the reported symptom.Internal inspection revealed that the connection to the primary pin of the belly patch was partially connected (with some wires broken out of iec standards) causing an intermittency and variable resistances.The reported symptom was duplicated by signal observation and internal inspection.Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to an intermittent resistance to the active belly patch pin.The reported issue will continue to be trended.

• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23006586
• Report Number: 2184149-2025-00148
• Device Sequence Number: 10502352
• Product Code: DQK
• UDI-Device Identifier: 05415067033611
• UDI-Public: (01)05415067033611(10)985860001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• 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): 09/30/2025

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: 985860001
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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