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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 FIXATIONDEFIBRILLATION 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 7120/65
Event Date 10/27/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

It was reported that the device delivered inappropriate therapy due to noise. During the explant procedure, insulation damage was observed. The lead was capped with no consequences to the patient.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. A partial lead was returned measuring 24. 5 cm from the connection pin. Analysis found an insulation abrasion at 15. 6 cm from the connector pin. A complete analysis could not be performed without the entire lead.

 
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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
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 Key1982170
MDR Report Key1954890
Event Key1851885
Report Number2017865-2011-00251
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type Health Professional,User facility
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 Received01/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date04/25/2011
Device MODEL Number7120/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/27/2010
Device Age30 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/27/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2008
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: 01/10/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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