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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 7122/65
Device Problems Break; Oversensing; Low impedance
Event Date 10/12/2011
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

Clarification- external insulation abrasion was found be- tween 38. 8cm and 40. 9cm from connector pin. The insulation lining of the conductor cables was compromised in this area. Externalized conductors were not observed in analysis of the returned lead.

 
Event Description

The lead presented with noise and decrease in impedance. Insulation break suspected. When the lead was explanted externalized conductors were observed.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received the reported field experience was confirmed. Analysis found lead insulation damage consistent with clavicle crush.

 
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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 Key2429937
MDR Report Key2409093
Event Key2305929
Report Number2017865-2012-00506
Device Sequence Number1
Product CodeNVY
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Followup,Initial
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 Date08/31/2013
Device MODEL Number7122/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/17/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/12/2011
Device Age13 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/14/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/31/2010
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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