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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 7122/65
Device Problem No Known Device Problem
Event Date 01/24/2011
Event Type  Malfunction  
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 found insulation abrasion at 57. 7cm - 58cm at the proximal end of the rv shock coil. The abrasion occurred from the outside on one side of the lead body. The location and mode of this abrasion is consistent with that caused by friction with another implanted device.

 
Event Description

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

 
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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 Key2045079
MDR Report Key2015063
Event Key1912059
Report Number2017865-2011-02244
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 Date12/31/2011
Device MODEL Number7122/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/30/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age23 mo
Event Location Other
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/24/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/10/2008
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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