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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISIONDURATA STS OPTIM ACTIVE FIXATIONDEFIBRILLATION LEAD

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ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD   Back to Search Results
Model Number 7120/60
Device Problem No Known Device Problem
Event Date 01/12/2011
Event Type  Malfunction  
Event Description

This report is to advise of an event observed during analysis.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. Reliability laboratory technician. (b)(4) no complaint was received with return of the device. Failure (event) observed during analysis. Analysis found insulation abrasion at 53cm from the connector, exposing the df-1 rv cables. The df-1 cables insulations were normal. The lead abrasion is consistent with that produced by friction with another device.

 
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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 Key2044726
MDR Report Key2014710
Event Key1911706
Report Number2017865-2011-02098
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type Other
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 Received03/10/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device EXPIRATION Date03/31/2011
Device MODEL Number7120/60
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age28 mo
Event Location Other
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/12/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/06/2008
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: 03/10/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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