MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 100014514

Device Problems Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

One velocity amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels appeared to have no physical damage.All of the mounting hardware was secured.Normal wear and tear was observed on the exterior enclosure.No other visible anomalies were observed.When the amplifier was powered on and had timed in, it was displaying a flashing yellow led.The board status shows the current source board was not seen in board status.Error logs showed numerous power up errors for this board.The analysis performed identified the current source board had lost its field-programmable gate array (fpga) that led to the reported complaint.The results of the investigation concluded the cause for the reported event was due to a faulty fpga circuitry on the current source board.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

During a wolff-parkinson-white syndrome ablation procedure, when the amplifier was powered on the status light flashed orange and the error message "amplifier error.Log out and power cycle both the ensite velocity dws and amplifier before restarting.Contact sjm technical support" was received.The amplifier was power cycled several times with no resolve.The procedure was cancelled and rescheduled for a later time.There were no adverse consequences to the patient.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7148418
• MDR Text Key: 95839928
• Report Number: 2184149-2017-00075
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100014514
• Other Device ID Number: 05414734210713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Date Device Manufactured: 01/21/2015
• 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 Outcome(s): Other