• 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 DURATA

  • 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 DURATA Back to Search Results
Model Number 7120
Device Problem Under-Sensing (1661)
Patient Problem No Code Available (3191)
Event Date 04/18/2012
Event Type  Injury  
Event Description
Non invasive programmed stimulation of icd, revealed undersensing of ventricular fibrillation after induction. Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDURATA
Type of DeviceDURATA
Manufacturer (Section D)
MDR Report Key2561677
MDR Text Key2753593
Report NumberMW5025285
Device Sequence Number1
Product Code LWS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/17/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2012
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7120
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/02/2012 Patient Sequence Number: 1