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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; No Match Back to Search Results
Model Number CD3361-40QC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pericardial Effusion (3271)
Event Date 07/27/2023
Event Type  Injury  
Event Description
It was reported that patient presented for generator change procedure.Fluid was noted in patient's device pocket.Patient's implantable cardioverter defibrillator (icd) was explanted and replaced.The patient was stable.
 
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Brand Name
UNIFY 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 Key18062183
MDR Text Key327239719
Report Number2017865-2023-51538
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 11/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCD3361-40QC
Device Lot NumberP000155022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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