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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 Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Further information requested but not received.
 
Event Description
It was reported a patient's implantable cardioverter defibrillator (icd) presented in backup vvi mode due to a hardware reset with no bdfo available.No changes were reported.The patient status was unknown.
 
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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 Key18773557
MDR Text Key336317873
Report Number2017865-2024-33388
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeAG
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/23/2024
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 Date02/29/2024
Device Model NumberCD3361-40QC
Device Lot NumberP000141775
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/05/2024
Initial Date FDA Received02/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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