MAUDE Adverse Event Report: ST. JUDE MEDICAL 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 02/15/2024

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation, there was a self-test issue with the ensite x amplifier, resulting in cancellation of the procedure.The ensite x amplifier status light was orange.The fiber optic cable was replaced, and the ensite x amplifier was rebooted several times, but the issue was not resolved.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6, h11.One ensite x amplifier was received for evaluation.The field reported event was not able to be duplicated.Evaluation testing was successful.Based on the information provided to abbott and the investigation performed, the reported event was not able to be confirmed, and the root cause remains undetermined.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 AMPLIFIER
• Type of Device: 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: 18789064
• MDR Text Key: 336342015
• Report Number: 2184149-2024-00038
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K202066, K22
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: 9132292
• 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: 02/19/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• 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