MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US); Computer, diagnostic, programmable

Model Number	ENSITE-SEK-5-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident of the patch errors could not be conclusively determined.
Event or Problem Description
During a supraventricular tachycardia procedure, there was a procedural delay due to a communication issue.After the patient was draped, validation was performed and the system generated a "validation succeeded" message, quickly followed by an error for a "left leg or system reference" issue.When looking at the log files it showed a "loose left leg patch".The left leg patch was checked and applied well.The connection to the surface link was checked too.Validation was attempted again but the same error message and an impedance error message also appeared.The left leg and system reference patches were replaced and a new study was started.Validation was attempted again with no success.The surface link was replaced with no resolution.The amplifier was replaced with no resolution either.The patches were replaced again with a third set, the dws and amplifier were rebooted, and new study was also started and the issue was resolved.The procedure was completed with no adverse consequences to the patient.

• Brand Name: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US)
• Common Device Name: Computer, diagnostic, programmable
• Manufacturer (Section D): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24966500
• Report Number: 3008452825-2026-00228
• Device Sequence Number: 17382096
• Product Code: DQK
• UDI-Device Identifier: 05415067032379
• UDI-Public: (01)05415067032379(10)11223775(17)270630
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K221213
• 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
• Report Date (Section B): 04/23/2026

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-SEK-5-01
• Device Lot Number: 11223775
• Was Device Available for Evaluation?: No
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 68 KG