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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 PASSIVE FIXATIONDEFIBRILLATION LEAD

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ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DURATA STS OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD   Back to Search Results
Model Number 7170/65
Device Problems Oversensing; Inappropriate shock
Event Date 02/24/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the patient received inappropriate therapy due to noise. The lead was explanted.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. Analysis found the outer insulation abrasion at 12cm from the connector pin. The sensing cable was exposed and abraded in the same area. This could cause the oversensing when the exposed metal filars of the sensing cable comes in contact with the icd.

 
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Brand NameDURATA STS OPTIM PASSIVE 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 Key2115404
MDR Report Key2084197
Event Key1981173
Report Number2017865-2011-03682
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type User facility,Company Representative
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 Received05/11/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date05/29/2011
Device MODEL Number7170/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/28/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/24/2011
Device Age33 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/24/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/29/2008
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: 05/11/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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