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

Model Number 100014514

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

No conclusion code available one ensite velocity¿ system velocity amplifier was received for analysis.When the amplifier powered on, it failed to initialize and displayed a flashing amber led which confirmed the reported event.Board status showed the current source in slot 2 was inactive.Review of the log files showed various power-up errors for the current source board in slot 2.Upon further investigation, the power-up issue was duplicated in the board tester and isolated to the field-programmable gate array (fpga) circuitry.After several attempts, the fpga firmware was reloaded into the board.However, on the next power cycle, the firmware was unable to be retained and the issue remained.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was isolated to the 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 the procedure, the amplifier would not boot.The patient was already on the table when the procedure was cancelled.There were no 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: 7432271
• MDR Text Key: 105520310
• Report Number: 2184149-2018-00047
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 03/30/2018
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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