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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 PASSIVE FIXATION DEFIBRILLATION 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 Low impedance; Device Issue
Event Date 04/26/2011
Event Type  Injury  
Manufacturer Narrative

Clarification-the reported impedance anomaly was confirmed. Analysis found internal abrasion between 7cm and 8cm from the lead tip. Electrical analysis revealed a short circuit between the sensing and pacing conductor and inner coil due to the lead insulation damage.

 
Event Description

It was reported that after interrogation, low ventricular lead impedance was observed. The lead was explanted due to lead defect.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received the reported impedance anomaly was confirmed. Analysis found inside-out abrasion between 7cm and 8cm from the lead tip. Electrical analysis revealed short circuit between the sensing and pacing coil due to the lead insulation damage.

 
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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
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 Key2183459
MDR Report Key2157205
Event Key2054160
Report Number2017865-2011-04424
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,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date02/06/2012
Device MODEL Number7170/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/13/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/26/2011
Device Age27 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received04/26/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/06/2009
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: 07/12/2011 Patient Sequence Number: 1
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