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

Model Number H702496

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

Event Type  Injury  

Event Description

Related manufacturer reference: 2184149-2017-00059.During a pulmonary vein isolation procedure clinically significant delays occurred.Following radiofrequency (rf) delivery the generator displayed an error message and could no longer deliver rf.The generator was restarted to resolve the issue and resume the procedure with a delay.Later while creating the model the system froze and it was not possible to continue the procedure.The issue was resolved by restarting the dws and selecting resume procedure.The system continued to perform slowly and furthered the delay.The procedure was completed with no adverse patient consequences.

Manufacturer Narrative

No conclusion code available.A review of the precision software files was performed.Intermittent pauses and enguide location freezing was confirmed.The cause for the reported clinically significant delay could not be determined but two factors were determined to have the potential to contribute to the performance issue experienced.First, the dws system logs showed the hard disk usage was at 93% which contributes to poor performance.Second, the study logs showed a software bug that excessively logs messages related to the reference sensor data which occurs when the data is invalid.This contributes to slow performance when disk space is low.It is recommended to remove old studies from the dws hard drive as when the hard drive is full old studies are automatically deleted and causes system slowdowns.

• Brand Name: ENSITE¿ PRECISION¿ SOFTWARE
• 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: 7063110
• MDR Text Key: 93066896
• Report Number: 2184149-2017-00058
• Device Sequence Number: 0
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K160210
• 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,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: H702496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: AMPERE¿ RF ABLATION GENERATOR
• Patient Outcome(s): Other