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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. ENSITE¿ PRECISION¿ SOFTWARE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM Back to Search Results
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.
 
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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 Key6657957
MDR Text Key78105595
Report Number2184149-2017-00011
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K160210
Number of Events Reported1
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 NumberH702496
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/22/2017
Initial Date FDA Received06/21/2017
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 Number1
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