MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X PATIENT REFERENCE SENSOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-PRSFRNT-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation with the patient in the room, a communication issue occurred which delayed the procedure.During prep, before starting the ablation procedure, the prs sensor was not displayed during prs recognition, and the prs was not recognized.The ensite system and amplifier were restarted, the field flame and prs were reconnected, and the magnetic field was turned on and off with no resolution.The patient temporarily left the catheterization room to exchange the dws for a non-abbot product (carto).After the preparation for carto was completed, the patient re-entered the room and the procedure was completed with no adverse consequences to the patient.The procedure started one hour late.There were no adverse effects on the patients due to the delay in the start.
Event or Problem Description
It was confirmed that this issue was resolved by replacing the prs sensor.The dws is still in use in the field without replacement.
Additional Manufacturer Narrative
Additional information: b5, d1, d4, g3.
Additional Manufacturer Narrative
One ensite x ep system patient reference sensor (prs) 3 was received for evaluation.Visual inspection revealed the prs connector was free of physical damage.The cable length was free of cuts or nicks.The prs-p was evaluated by performing a continuity test, which revealed all coils were functioning as expected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the reported communication issue and subsequent delay could not be determined.

• Brand Name: ENSITE¿ X PATIENT REFERENCE SENSOR
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18543083
• Report Number: 2184149-2024-00018
• Device Sequence Number: 20436016
• Product Code: DQK
• UDI-Device Identifier: 05415067046710
• UDI-Public: 05415067046710
• 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
• Report Date (Section B): 02/15/2024
• 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 Model Number: ENSITE-PRSFRNT-01
• Device Lot Number: 9115671
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 01/23/2024; 02/15/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 01/23/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male