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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 ACTIVE FIXATION DEFIBRILLATION 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
Device Problems Break; Low impedance
Event Date 11/01/2011
Event Type  Injury  
Manufacturer Narrative

Clarification - analysis found external insulation abrasion at 43. 5-45. 2cm from the helix end consistent with lead friction to the icd can. The rv conductor cables were exposed and insulation lining was compromised in this area.

 
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. Analysis found insulation abrasions.

 
Event Description

It was reported that low impedance was observed on the lead. The device was programmed off and the patient was fitted with a life vest. At the time of lead revision, insulation abrasion with externalized conductors was found. Lead was explanted and replaced.

 
Event Description

Correction-physician observed the lead frayed and coils were exposed (no externalized conductor) near the icd can. The patient is an active skeet shooter and uses his left side. The physicain suspects that this repeated trauma played a in the observed abrasion.

 
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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
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 Key2429965
MDR Report Key2409091
Event Key2305927
Report Number2017865-2012-00379
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 Date08/31/2011
Device MODEL Number7120/65
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/03/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/01/2011
Device Age38 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received11/02/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2008
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: 01/10/2012 Patient Sequence Number: 1
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