MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SEK-5-01
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, a connection issue occurred which caused a delay in procedure.An error message was noted stating: surface electrode impedance error.Confirm original surface electrode placement.Revalidation is recommended if the parch has moved to a new location".The surface link was exchanged and the patches were replaced which did not resolve the issue.The amplifier was then replaced and the issue remained.The system was then shut down completely and the amplifier and computer rebooted.A new study was started and the issue remained.A few of the circle impedance patches had fallen off the patient when we went back to look.Those were reattached and the procedure was eventually able to be completed by pressing down on the different patches at different points and signals were regained.
Additional Manufacturer Narrative
Two ensite x surface electrode kit neck patches were received for evaluation.One front, right, left leg and prs patches were also returned.The liners were not returned for evaluation, therefore functional testing was not possible.The reported connection issue was unable to be confirmed due to the condition of the returned device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the connection issue remains unknown.

• Brand Name: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US)
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19250984
• Report Number: 3008452825-2024-00258
• Device Sequence Number: 20663083
• Product Code: DQK
• UDI-Device Identifier: 05415067032379
• UDI-Public: (01)05415067032379(10)10154308(17)250630
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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
• Device Expiration Date: 06/30/2025
• Device Model Number: ENSITE-SEK-5-01
• Device Lot Number: 10154308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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
• Patient Age: 29 YR
• Patient Sex: Female