MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM; Computer, diagnostic, programmable

Model Number EE3000

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

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

One ensite velocity¿ amplifier was received for evaluation.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to a voltage out of range condition during post for catheter amplifier board in slot 9.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.

Event Description

During the atrial fibrillation procedure, self-test failure issues with the amplifier required multiple troubleshooting measures which did not resolve the issue and the procedure was cancelled.It was noted that the amplifier booted up and connected to the dws without issue, however, after a few moments, the amplifier status light went to solid amber.The amplifier was rebooted several times, all connections were unplugged, the power was unplugged and let sit for a minute all without resolution.Rebooted again to solid amber and it remained solid amber.The case was cancelled with no adverse consequences to the patient.

• Brand Name: ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
• 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: 18357998
• MDR Text Key: 330900676
• Report Number: 2184149-2023-00243
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201181
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EE3000
• Device Lot Number: 7946635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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