MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-AMP-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer report number: 2184149-2021-00333.During the redo atrial fibrillation procedure in voxel mode, a new study was started in the ensite x system.The cpu was not able to stablish connection with the amplifier.There was an error message reporting the connection was failing and a restart was recommended.The cpu and amplifier were rebooted four times each in different orders, but the issue persisted.All connections in the front and back of the amplifier were removed and reattached, and the amplifier was restarted again, but the issue persisted.The fiber optic cable between the cpu and the amplifier was replaced but the issue was not resolved.The procedure was completed using the ensite precision system.There were no adverse patient consequences, however, a procedure delay occurred due to these issues.
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.The review determined that no non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported incident could not be conclusively determined. .

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• 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: 12752294
• Report Number: 2184149-2021-00332
• Device Sequence Number: 1442620
• Product Code: DQK
• UDI-Device Identifier: 05415067032157
• UDI-Public: 05415067032157
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 11/29/2021

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-AMP-01
• Device Catalogue Number: ENSITE-AMP-01
• Device Lot Number: 7589643
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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 X DWS; ENSITE X DWS
• Patient Sex: Unknown