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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISIONRIATA ST OPTIM ACTIVE FIXATIONDEFIBRILLATION LEAD

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ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD   Back to Search Results
Model Number 7020/60
Device Problems Oversensing; High sensing threshold; Low sensing threshold
Event Date 01/28/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

The event reported in the field was confirmed in the laboratory. Insulation abrasion was observed at 11. 5cm from the connector pin near the trifurcation boot. This abrasion is consistent with lead friction to the icd can. The efte insulation on one of the proximal ring cables was abraded through, which allowed the cable to contact the icd can, creating the noise and sensing anomaly observed in the field.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. Device evaluation anticipated but not yet begun.

 
Event Description

It was reported that the r-waves have been steadily decreasing and the capture threshold increasing. Several aborted shocks due to noise were seen in the past few months. Hence, the lead was explanted.

 
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Brand NameRIATA ST 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 Key2045180
MDR Report Key2015164
Event Key1912160
Report Number2017865-2011-02070
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,Followup
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device EXPIRATION Date04/30/2010
Device MODEL Number7020/60
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/28/2011
Device Age45 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/28/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/23/2007
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: 03/10/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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