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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD

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ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD Back to Search Results
Model Number 7022/65
Device Problem Device displays error message
Event Date 07/05/2011
Event Type  Injury  
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received analysis found insulation abrasion consistent with friction to the icd can. One of the rv conductor cables was broken and melted.

 
Event Description

It was reported that the patient presented in-clinic with shocks. The device was interrogated and displayed possible problem in the hv circuit. Analysis of the icd showed evidence of a hv arc between the icd and damaged lead.

 
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Brand NameRIATA ST OPTIM ACTIVE FIXATION
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 Key2263981
MDR Report Key2242754
Event Key2139670
Report Number2017865-2011-06265
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type User facility,Company Representative
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 Received09/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date04/30/2010
Device MODEL Number7022/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/05/2011
Device Age3 yr
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/05/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/16/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/10/2011 Patient Sequence Number: 1
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