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 03/11/2024

Event Type  malfunction  

Event Description

During the ventricular tachycardia procedure, self-test issues with the amplifier resulted in the procedure being cancelled.The catheters and signals disappeared, an amplifier error message was displayed, and the amplifier continued to flash in orange.The system was powered off and restarted several times with no resolution.Technical support troubleshooting was also unsuccessful.The procedure was cancelled with no adverse consequences to the patient.The procedure was rescheduled and completed the next day using ensite precision.

• 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.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18994706
• MDR Text Key: 338830295
• Report Number: 2184149-2024-00056
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 8489559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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