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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 100014514
Device Problem Failure of Device to Self-Test (2937)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/16/2020
Event Type  Injury  
Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During an ablation procedure, while ablation was being performed the amplifier status light turned orange and an amplifier error message was received.The amplifier was power cycled and the tactisys and generator to amplifier cables were changed but the issue remained.As ablation was unable to be continued, the procedure was cancelled.There were no adverse consequences to the patient.
 
Event Description
During an ablation procedure, while ablation was being performed the amplifier status light turned orange and an amplifier error message was received.The amplifier was power cycled and the tactisys and generator to amplifier cables were changed but the issue remained.As ablation was unable to be continued, the procedure was cancelled.There were no adverse consequences to the patient.During further troubleshooting, some electrical modifications were made within the procedure room and there have been no further issues with the amplifier.The device has continued to work as intended.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident was due to electrical issues within the procedure room and was not related to the abbott device.
 
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Brand Name
ENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key10541571
MDR Text Key207172917
Report Number2184149-2020-00148
Device Sequence Number1
Product Code DQK
UDI-Device Identifier05414734210713
UDI-Public05414734210713
Combination Product (y/n)N
PMA/PMN Number
K141050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number100014514
Device Catalogue Number100014514
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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