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

Model Number	ENSITE-DWS-1.1
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, an impedance issue occurred and the procedure was cancelled.When attempting to ablate the cavotricuspid isthmus cti without anatomy (just with the help of the cs catheter), 0w displayed on the generator several times and the impedance rose to 999.The ampere generator had to be restarted twice, grounded, and a second neutral electrode had to be used.A loose contact was also noticed on the flexability.The procedure was more complex than expected, and several maps and had to be carried out.The patient became restless over time.The system displayed several warnings, including "voxel collection is suspended because the system has detected an impedance shift.Existing voxels were deleted to resolve the issue.Then, the field frame disconnected and could not be reconnected.The neck patch also showed as disconnected.The physician did not want to validate the examination again or carry out further troubleshooting.The procedure had to be stopped because the anatomical position was not reached.There were no adverse patient consequences.It is suspected the issue was the patient's fault as no similar problems have occurred since.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.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 received, the cause of the reported impedance issue occurred and subsequent cancellation could not be determined.

• Brand Name: ENSITE¿
• 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: 14712760
• Report Number: 2184149-2022-00145
• Device Sequence Number: 5234027
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: 05415067037725
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: Other
• Device Model Number: ENSITE-DWS-1.1
• Device Catalogue Number: ENSITE-DWS-1.1
• Device Lot Number: 8275729
• Was Device Available for Evaluation?: No
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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