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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; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number CD3371-40QC
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2023
Event Type  malfunction  
Event Description
It was reported that the patient presented in clinic.Interrogation of device noted that there was an overestimation of atrial threshold.No interventions were performed.There were no patient consequences.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
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 Key18117425
MDR Text Key327866892
Report Number2017865-2023-51841
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/05/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model NumberCD3371-40QC
Device Lot NumberA000123441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TENDRIL LEAD
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