MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	EN0020-P
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 2182269-2023-00048.During a paroxysmal supraventricular tachycardia (psvt) procedure, the ensite dws could not display the electrode image which caused a delay.The dws and amplifier were restarted and reconnected with no resolution.The patches were then replaced which resolved the issue.Additionally, electrodes 7-8 of the catheter did not display as expected in the right atrium.The cable and the pole in the junction box were changed with no resolution.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
one precision surface electrode kit left leg patch was received for evaluation.No visual anomalies were noted.The patch displayed continuity with no open circuits detected.In addition, the leg patch was able to be validated with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported recognition issue and subsequent delay remains unknown.
Additional Manufacturer Narrative
**udi related data quality updates only**.
Additional Manufacturer Narrative
**udi related data quality updates only**.
Event or Problem Description
Fda request to update device model information.Follow up report required.

• Brand Name: ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
• 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; 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18022614
• Report Number: 3008452825-2023-00492
• Device Sequence Number: 17805098
• Product Code: DQK
• UDI-Device Identifier: 05415067041715
• UDI-Public: (01)05415067041715(10)8849713(17)240630
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K201181
• 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): 07/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: EN0020-P
• Device Catalogue Number: EN0020-P
• Device Lot Number: 8849713
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 11/15/2023; Not provided; 07/09/2024; 07/10/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/15/2023; 06/19/2024; 07/22/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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: LIVEWIRE¿ EP CATHETER.
• Patient Sex: Unknown