• 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 FIXATION, DF-4 CONNECTORDEFIBRILLATION 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 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD   Back to Search Results
Model Number 7121Q/58
Device Problems Fracture; Oversensing; Low sensing threshold
Event Date 03/10/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. Analysis found insulation abrasion at 44. 1cm to 45cm from connector pin. Distal coil was abraded at the same location and was also fractured. The abrasion found was consistent with that due to friction to another device. Other: na.

 
Event Description

It was reported that the patient presented to the er with general symptoms of discomfort. Device interrogation revealed poor ventricular sensing and intermittent oversensing. The patient did not receive inappropriate shocks. Manipulation of the icd and torso of the patient while lying on their side produced consistent noise. The lead was explanted and replaced. Lead fracture observed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
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 Key2115271
MDR Report Key2084058
Event Key1981034
Report Number2017865-2011-03601
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 Date02/28/2011
Device MODEL Number7121Q/58
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/25/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/10/2011
Device Age1 yr
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received03/10/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/25/2010
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
-
-