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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3269-40Q
Medical Device Problem Code Under-Sensing (1661)
Health Effect - Clinical Code Ventricular Tachycardia (2132)
Date of Event 11/22/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that intermittent undersensing was observed on the device during ventricular tachycardia episodes that was converted.Programming changes were made to address the issue.Patient was stable.
 
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Brand Name
QUADRA ASSURA MP (DDQP+)
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8136155
Report Number2938836-2018-12722
Device Sequence Number1233973
Product Code LWS
UDI-Device Identifier05414734505710
UDI-Public05414734505710
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2014
Device Model NumberCD3269-40Q
Device Lot Number4066163
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/22/2018
Initial Report FDA Received Date12/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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