• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT COMPUTER, DIAGNOSTIC, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL, COSTA RICA LTDA ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number EN0020-P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Tears (2516)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
Following atrial fibrillation ablation, the patients skin was torn when removing the blue patch from the patients leg. The damage was localized on the left knee.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, COSTA RICA LTDA
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS 1897-4050
Manufacturer (Section G)
ST. JUDE MEDICAL, COSTA RICA LTDA
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS 1897-4050
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key9483157
MDR Text Key173166677
Report Number3008452825-2019-00635
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K183128
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 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Model NumberEN0020-P
Device Catalogue NumberEN0020-P
Device Lot Number7233472
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2019 Patient Sequence Number: 1
-
-