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

Model Number H702496

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the precision software files was performed.The respiration pattern was irregular throughout the study.The relatively slow adaptation of respiration compensation in some situations is expected behavior.Abrupt changes to the respiration pattern can cause the computed catheter locations to show motion or appear distorted.This motion can continue until the new respiration pattern becomes regular and the adaptive respiration compensation algorithm adapts to the new pattern.At times the respiration cycle was longer than 20 seconds.Some respiration cycles with longer time scales are not fully compensated by the algorithm, which may lead to the catheters slowly moving.The file review also showed catheter shifts.The cause for these shifts cannot be conclusively determined however, based on investigation of other similar events the shifts are due to patient repositioning, surface electrode placement or a software anomaly that displays a shift when the magnetic locations become unreliable.

Event Description

During an ablation procedure, a clinically significant delay occurred.At the beginning of the procedure, there was movement of the catheter due to the patient¿s heart beat and respiration.The respiratory compensation function was unable to stabilize the catheter.The respiration pattern was monitored and noted to be flat at times.Additionally, a message was displayed indicating the system experienced a catheter shift when the respiration pattern was flat.After some time, the issue resolved on its own and the procedure was completed with no adverse consequences to the patient.The delay occurred due to the continued instability of the catheters.

• 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: 6657957
• MDR Text Key: 78105595
• Report Number: 2184149-2017-00011
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K160210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/21/2017

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: H702496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/21/2017
• 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