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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3367-40QC
Device Problems Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661)
Patient Problems Cardiac Arrest (1762); Ventricular Tachycardia (2132)
Event Type  Injury  
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 Description
It was reported the patient was admitted to the hospital in ventricular tachycardia (vt) storm and received multiple shocks.It was noted that their implantable cardioverter defibrillator failed to detect vt within its programmed detection zone resulting in inappropriately withheld therapy.Patient was found unresponsive and an external cardioversion therapy was used to restore the patient's sinus rhythm.The device was reprogrammed.
 
Event Description
New information received notes device serial number and the patient was in stable condition.
 
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Brand Name
QUADRA ASSURA ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11114686
MDR Text Key225037361
Report Number2017865-2020-23479
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Model NumberCD3367-40QC
Device Lot NumberP000064860
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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