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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA DDQP+; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA DDQP+; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3267-40
Device Problem Difficult to Interrogate (1331)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that poor interrogation was observed.It was unknown if this was due to the programmer or the device.The patient is scheduled for a follow-up.
 
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Brand Name
QUADRA ASSURA DDQP+
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jaime chavez
645 almanor avenue
sunnyvale, CA 94085
8184934022
MDR Report Key5629018
MDR Text Key44340957
Report Number2938836-2016-03306
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2014
Device Model NumberCD3267-40
Device Lot Number3882754
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2012
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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