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

Model Number 100014514

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

Patient Problem No Information (3190)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, the amplifier turned to an amber light and the procedure was cancelled.A green light was observed prior to the amplifier turning amber.The fan filter was checked and the amplifier was power cycled three times, but the issue remained.

Event Description

During an atrial fibrillation ablation procedure, the amplifier turned to an amber light and the procedure was cancelled.A green light was observed prior to the amplifier turning amber.The fan filter was checked and the amplifier was power cycled three times, but the issue remained.There were no adverse consequences to the patient.

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier pn 100015555 and sn (b)(6) was received into the lab for analysis for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Normal signs of wear were observed on exterior chassis which is consistent with clinical usage.Power was applied to the returned amplifier which successfully completed the post (power on self-test) and the system status light changed to green.A review of the system log files for the reported event date revealed multiple and repeated voltage out of range and temperature shutdown faults stored, which confirms the reported issue.The root cause was isolated to the catheter amplifier pca (printed circuit assembly) pn 100013875 and sn (b)(6) located in the slot 6 location.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to abnormal functionality of the catheter amplifier board at the slot six location.

• Brand Name: ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10647852
• MDR Text Key: 210366681
• Report Number: 2184149-2020-00168
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• PMA/PMN Number: K141050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100014514
• Device Catalogue Number: 100014514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other