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

Model Number ENSITE-AMP-02

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2024

Event Type  malfunction  

Event Description

During preparation for a supraventricular tachycardia ablation procedure, with the patient under moderate sedation, a self-test issue occurred and the procedure was cancelled.At the start of the study, the orange light was flashing on the amplifier and error messages were displayed on the dws.Tech support was contacted, and troubleshooting was performed which did not resolve the issue and the case was cancelled with no patient consequences.

Manufacturer Narrative

One ensite x amplifier was received for evaluation.Visual inspection revealed the front ports, rear ports, and chassis show signs of wear consistent with use over time.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were temporarily exchanged.The amplifier was powered on and then the amplifier booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software.The field service tool (fst) was then connected, and the amplifier passed post.The field functional test was then performed and was successful.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 provided to abbott and the investigation performed, the cause of the reported self test issue and subsequent cancellation remain unknown.

• Brand Name: ENSITE¿ X AMPLIFIER
• Type of Device: 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. (AF-ST. PAUL); one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19133245
• MDR Text Key: 340714423
• Report Number: 2184149-2024-00078
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: (01)05415067034755(10)8068123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Model Number: ENSITE-AMP-02
• Device Lot Number: 8068123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 66 KG