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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISIONUNIFY ASSURAIMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION UNIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR   Back to Search Results
Model Number CD3261-40Q
Event Date 05/15/2012
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received. (b)(4): review of quality records. Analysis was normal. No anomaly was found.

 
Event Description

It was reported that the system was explanted due to infection.

 
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Brand NameUNIFY ASSURA
Type of DeviceIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key2668208
MDR Report Key2637955
Event Key2534611
Report Number2017865-2012-04843
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other Health Care Professional
Device EXPIRATION Date08/31/2013
Device MODEL NumberCD3261-40Q
Device Catalogue NumberSMTFY999
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/29/2012
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/15/2012
Device Age3 mo
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received05/15/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/22/2012
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: 07/02/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
(B)(4)
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