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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 100015555
Device Problem Failure of Device to Self-Test (2937)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.  .
 
Event Description
During the procedure, a clinically significant delay occurred. When attempting to ablate, the amber light emitted from the amplifier and the ablation catheter would no longer function. The amplifier was reset, the patches were verified, and a non-abbott catheter was attempted with no resolution. A non-abbott mapping system was used causing a two hour delay in procedure. The procedure was completed successfully with no adverse consequences to the patient.
 
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Brand NameENSITE VELOCITY SYSTEM VELOCITY AMPLIFIER
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key9497464
MDR Text Key172254635
Report Number2184149-2019-00253
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K160187
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 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number100015555
Device Catalogue Number100014514
Device Lot Number5185930
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/19/2019 Patient Sequence Number: 1
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