• 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 CARDIAC RHYTHM MANAGEMENT DIVISION RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD

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

ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD Back to Search Results
Model Number 7022/60
Device Problem Break
Event Date 06/21/2011
Event Type  Injury  
Event Description

During a medtronic lead revision procedure, the physician decided to replace the lead with a previous unused pace/sense portion of rv lead. After uncapping, a slight insulation abrasion above the bifurcation was observed. The physician made the decision to patch the lead with medical adhesive and continue to monitor it.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRIATA ST OPTIM ACTIVE FIXATION
Type of DeviceDEFIBRILLATION LEAD
Manufacturer (Section F)
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
15900 valley view court
sylmar CA 91342
Manufacturer (Section D)
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
15900 valley view court
na
sylmar CA 91342
Manufacturer Contact
noemi schambach
15900 valley view court
na
sylmar , CA 91342
(408) 522 -6774
Device Event Key2264006
MDR Report Key2242755
Event Key2139671
Report Number2017865-2011-06264
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Modification/Adjustment
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date07/31/2010
Device MODEL Number7022/60
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/21/2011
Device Age47 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/21/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/22/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/10/2011 Patient Sequence Number: 1
-
-