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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3369-40Q
Device Problems Inappropriate or Unexpected Reset (2959); Compatibility Problem (2960)
Event Date 03/03/2022
Event Type  malfunction  
Event Description
It was reported that a patient presented in-clinic for magnetic resonance imaging (mri).After enabling mri settings on the patient's implantable cardioverter defibrillator (icd) and following appropriate mri procedure, the patient's icd was found to have switched to back-up vvi mode due to the mri scan.Corrective programming changes were made on (b)(6) 2022 to successfully restore the device.The patient was discharged and no additional patient consequences were reported.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key13762142
MDR Text Key287677175
Report Number2017865-2022-05389
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508377
UDI-Public05414734508377
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Report Date 03/14/2022
1 Device 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 Date05/31/2023
Device Model NumberCD3369-40Q
Device Catalogue NumberCD3369-40Q
Device Lot NumberA000110639
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
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