• 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 DIVISIONDURATA STS OPTIM ACTIVE FIXATIONDEFIBRILLATION LEAD

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

ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD   Back to Search Results
Model Number 7121/65
Device Problems Break; Oversensing
Event Date 02/22/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received analysis found insulation abrasion at 15-19cm from the connector pin. The svc cable on the proximal part of the lead was abraded; this is characteristic of lead friction to icd can. The reported oversensing could occur when the exposed metal filars of the svc cables came in contact with the icd can.

 
Event Description

Patient presented to the clinic after receiving therapy. The stored egms showed several episodes with oversensing. Upon explant, insulation abrasion was observed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDURATA STS OPTIM ACTIVE FIXATION
Type of DeviceDEFIBRILLATION LEAD
Manufacturer (Section F)
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
15900 valley view court
na
sylmar CA 91342
Manufacturer (Section D)
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
15900 valley view court
na
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 Key2115394
MDR Report Key2084194
Event Key1981170
Report Number2017865-2011-03584
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date05/31/2011
Device MODEL Number7121/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/22/2011
Device Age34 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/23/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/08/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/11/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
-
-