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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 ACTIVE FIXATION, DF-4 CONNECTORDEFIBRILLATION 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 7171Q/65
Device Problems Break; Oversensing
Event Date 10/05/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

Clarification- no insulation damage with externalized conductor was observed on the returned lead. The distal tip and inner coil were not returned.

 
Event Description

At follow-up, noise was observed. The noise was not reproduced with arm movements. Upon explant, externalized conductor was observed at the ring.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received a complete anaysis could not be performed due to partial lead returned, cut in two pieces.

 
Event Description

During the lead extraction, the insulation and conductor cable disconnected from the inner conductor coil. It was unclear if the lead was damaged before or during the lead extraction procedure.

 
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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
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 Key2430036
MDR Report Key2409165
Event Key2306001
Report Number2017865-2012-00585
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date11/30/2010
Device MODEL Number7171Q/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/13/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/05/2011
Device Age22 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/05/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/24/2009
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: 01/10/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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