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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD

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ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD Back to Search Results
Model Number 7122Q/58
Device Problem No Known Device Problem
Event Date 07/26/2011
Event Type  Malfunction  
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. (b)(4). No complaint was received with return of the device. Failure (event) observed during analysis. The lead exhibited normal electrical characteristics. Visual inspection found external insulation abrasion at 19. 7cm to 20cm from connector pin. The rv cables were exposed but the etfe coating was not compromised. The damage found is consistent with friction to the icd can.

 
Event Description

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

 
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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
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 Key2264171
MDR Report Key2242920
Event Key2139817
Report Number2017865-2011-06474
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type Other
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 Received09/11/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device EXPIRATION Date08/31/2010
Device MODEL Number7122Q/58
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age22 mo
Event Location Other
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/26/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/27/2009
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: 09/11/2011 Patient Sequence Number: 1
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