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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; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA ICD; No Match Back to Search Results
Model Number CD3367-40QC
Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661)
Patient Problem Arrhythmia (1721)
Event Date 09/30/2023
Event Type  Injury  
Event Description
It was reported that a patient presented with inadequate therapy and under-sensing noted on the patient's implantable cardioverter defibrillator.Thie results in a sustain arrhythmia and required external defibrillation to resolve.Corrective programming changes were made.No further adverse patient consequences were reported.
 
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Brand Name
QUADRA ASSURA ICD
Type of Device
No Match
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17982439
MDR Text Key326233157
Report Number2017865-2023-50341
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/22/2023
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
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Model NumberCD3367-40QC
Device Lot NumberP000073545
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/03/2023
Initial Date FDA Received10/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2019
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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