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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC., CRMD UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3357-40Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/14/2014
Event Type  Injury  
Event Description
It was reported that the system was explanted due to infection.Patient doing fine following the procedure.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.Evaluation description: analysis was normal.No anomaly was found.
 
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Brand Name
UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sharon mathew
645 almanor avenue
sunnyvale, CA 94085
4085226327
MDR Report Key4372246
MDR Text Key5233174
Report Number2938836-2014-19314
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2015
Device Model NumberCD3357-40Q
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1999/CWJ016015, 7122Q/BNY032684,511211/220473
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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