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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY CARDIAC MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL ENSITE VELOCITY CARDIAC MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number EE3000
Device Problem Failure of Device to Self-Test (2937)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
Event Description
During an atrial fibrillation ablation procedure, the amplifier was not able to pass the self test. The power cables and power supply were exchanged but the issue persisted and orange lights continued to flash. The procedure was cancelled due to this issue. There were no adverse patient consequences.
 
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Brand NameENSITE VELOCITY CARDIAC MAPPING SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key11540018
MDR Text Key242952008
Report Number2184149-2021-00067
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEE3000
Device Catalogue Number100014514
Device Lot Number7661075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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