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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC., CRMD QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3367-40QC
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2014
Event Type  malfunction  
Event Description
It was reported during a clinic check-up, the patient could not feel the device vibration.Several tests were performed but were unsuccessful.No resolution was recommended or completed.No adverse consequences were detected.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
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Brand Name
QUADRA 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 Key4372221
MDR Text Key5114238
Report Number2938836-2014-19344
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,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 Received12/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2016
Device Model NumberCD3367-40QC
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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