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

Model Number 100014514

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

Prior to the procedure, the amplifier would not pass the self-test.The amplifier was connected to different outlets, the filter was cleaned and re-booted several times but the issue remained.The procedure was cancelled and rescheduled.

Manufacturer Narrative

Based on the information provided and the investigation performed, the root cause of the reported event was isolated to a faulty temperature sensor on the catheter amplifier board in slot 12.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.

• 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: 6677802
• MDR Text Key: 78717452
• Report Number: 2184149-2017-00013
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2010
• 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