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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 DEFIBRILLATION 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 7121/65
Device Problems Oversensing; Inappropriate shock
Event Date 06/09/2011
Event Type  Injury  
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. The reason for return was confirmed. An insulation abrasion was noted at 8 cm from the connector end consistent with friction to the icd can. The reported over sensing could occur when the exposed metal filars of the sensing coil comes in contact with the icd can. The lead exhibited normal electrical characteristics.

 
Event Description

It was reported that the patient received inappropriate therapy. Lead was explanted and replaced.

 
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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
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 Key2263747
MDR Report Key2242441
Event Key2139400
Report Number2017865-2011-06396
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 Date01/31/2012
Device MODEL Number7121/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/09/2011
Device Age29 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received06/09/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/29/2009
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: 09/10/2011 Patient Sequence Number: 1
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