MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 1; 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	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation for a premature ventricular contractions procedure, after the patient was prepped for the procedure, it was reported that there was a prs a not connected message resulting in a delay.Disconnecting, and reconnecting did not resolve the issue.Swapping ports did not resolve the issue either.The issue was then resolved by using a prs from a different hospital.There were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.One ensitex patient reference sensor front (prs-a) was received.The eeprom reader was unable to read the storage within the solid state component (which stores the initialization files, date of manufacture, and batch information.Evaluation testing revealed all coils were functioning as expected.The prs-a was attached to an ensitex amplifier, a field frame, field frame cable, all within the test station real time magnetic tracker study.The sensor was unable to initialize as a tool error 13 was observed in the piu error log window, which duplicated the reported symptom.Per the vendor documentation, this represents: ¿13 unable to initialize the port handle¿.This prs was unable to initialize, and will cause the device to not start or function.Pin to pin evaluation testing revealed all coils are reading nominal values, which were successful.The reported event was able to be duplicated by connecting within a magnetic study.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to the eeprom initialization data.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.

• Brand Name: ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 1
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16686677
• Report Number: 2184149-2023-00077
• Device Sequence Number: 20673252
• Product Code: DQK
• UDI-Device Identifier: 05415067033284
• UDI-Public: 05415067033284
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202066
• 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,Followup
• Report Date (Section B): 04/17/2023

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: ENSITE-PRSFRNT-01
• Device Catalogue Number: ENSITE-PRSFRNT-01
• Device Lot Number: 8830274
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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: Unknown