MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION¿ MAGNETIC FIELD FRAME; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	H702469
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite precision¿ magnetic field frame sn (b)(4) was received for evaluation at the tech center.Visual inspection revealed the port, the chassis, and labels were free of physical damage.The field frame was evaluated using a test station with tracker software, a test precision link, patient reference sensors, field frame cable, active electrode catheter and a wet lab.Evaluation testing of the field frame was unsuccessful as the field frame was connected through the tracker software and an error was displayed which no communication was established.The reported event was confirmed by communication testing and the root cause was isolated to a non-functioning field frame.
Event or Problem Description
Related manufacturing reference: 2184149-2023-00022.During the svt ablation procedure, it was noted that there was no magnetic location which caused delays to treatment.A precision link and field frame from a second system were used and the procedure was successfully completed with no adverse consequences to the patient.

• Brand Name: ENSITE PRECISION¿ MAGNETIC FIELD FRAME
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: 16397797
• Report Number: 2184149-2023-00040
• Device Sequence Number: 17750548
• Product Code: DQK
• UDI-Device Identifier: 05415067024695
• UDI-Public: 05415067024695
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183128
• 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): 02/17/2023

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: H702469
• Device Catalogue Number: H702469
• Device Lot Number: 6650109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• 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: 01/23/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE¿ PRECISION¿ LINK SENSOR ENABLED
• Patient Sex: Unknown