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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; No Match Back to Search Results
Model Number CD3365-40Q
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2024
Event Type  malfunction  
Event Description
It was reported the patient presented for implant procedure.During surgery, it was discovered the implantable cardioverter defibrillator (icd) was in backup mode.The physician elected to complete the procedure with a different icd.The patient was in stable condition.
 
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Brand Name
QUADRA ASSURA CRT-D QUAD RF HV
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 Key19115297
MDR Text Key340268802
Report Number2017865-2024-38290
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508292
UDI-Public(01)05414734508292(10)A000151376(17)251231
Combination Product (y/n)N
Reporter Country CodeIN
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 04/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCD3365-40Q
Device Lot NumberA000151376
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/11/2023
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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