MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM CATHETER CONNECTOR CABLE; MAGNETIC EXTENSION 10 PIN ENSITE X; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	A-ENS-MAGEXT-CBL
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial tachycardia procedure, communication issues requiring troubleshooting measures resulted in a procedural delay.The cable was replaced and the procedure was completed with no adverse consequences to the patient.When the catheter was inserted into the heart and connected to the tactisys and the direct connect cable, it was noted that the se indicator remained red, and the catheter navigation could not be displayed in voxel mode.The catheter was replaced and the ensite was restarted, but with no resolution.The direct connect cable was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Corrected data: b5, d2, d3, h2.
Event or Problem Description
Follow up report to address corrected manufacturing site information.
Additional Manufacturer Narrative
One magnetic extension 10 pin, ensite x diagnostic catheter cable was received for evaluation.All functional pins met specifications during electrical testing; however, when tested with a test box, no continuity was detected on pin 4.Further investigation determined pin receptacle inserts for pin 4 were no longer in the distal connector plug, consistent with the intermittent continuity detected and the reported event.The receptacle pin detachments were determined to be supplier related.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Abbott will continue to monitor this issue.
Additional Manufacturer Narrative
Udi related data quality updates only.Additional information: d4, g3, h2, h11.

• Brand Name: ENSITE¿ X EP SYSTEM CATHETER CONNECTOR CABLE; MAGNETIC EXTENSION 10 PIN ENSITE X
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18166005
• Report Number: 3005334138-2023-00537
• Device Sequence Number: 20368642
• Product Code: IKD
• UDI-Device Identifier: 05415067031822
• UDI-Public: (01)05415067031822(10)8685649(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 11/30/2023
• Device Model Number: A-ENS-MAGEXT-CBL
• Device Catalogue Number: A-ENS-MAGEXT-CBL
• Device Lot Number: 8685649
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 01/26/2024; 06/11/2024; 07/08/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/21/2023; 02/01/2024; 06/19/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2022
• 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