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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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ST. JUDE MEDICAL ENSITE X EP SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number ENSITE-SYSTEM-01
Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Perforation (2513)
Event Date 05/06/2021
Event Type  Injury  
Event Description
During a premature ventricular contraction (pvc) ablation procedure, a pericardial effusion occurred.Towards the end of the procedure, while in voxel mode in the left ventricle, the ablation catheter perforated through the posterior floor.Contact force never reached greater than 11g.The patient then became hypotensive and a pericardial effusion was visualized on ice.A pericardiocentesis was performed to stabilize the patient.The patient is currently in stable condition and has been discharged.It was thought that the use of the ensite x system in voxel mode contributed to the event.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Abbott is unable to evaluate the product involved in this incident since the electronic files from the reported event date were not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.
 
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Brand Name
ENSITE X EP SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
MDR Report Key11921874
MDR Text Key253778649
Report Number2184149-2021-00187
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/24/2021
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 NumberENSITE-SYSTEM-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/06/2021
Initial Date FDA Received06/02/2021
Supplement Dates Manufacturer Received06/22/2021
Supplement Dates FDA Received06/24/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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