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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; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; No Match Back to Search Results
Model Number CD3371-40QC
Device Problems Over-Sensing (1438); Pacing Problem (1439)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2024
Event Type  malfunction  
Event Description
It was reported during in clinic follow up that the implantable cardioverter defibrillator exhibited post-paced t-wave oversensing (pptwos) that resulted in inappropriate mode switch.Programming changes were recommended but not yet completed.The patient was stable and asymptomatic.
 
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Brand Name
QUADRA ASSURA MP 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 Key19176904
MDR Text Key341049013
Report Number2017865-2024-39555
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508407
UDI-Public(01)05414734508407(10)P000172527(17)250531
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCD3371-40QC
Device Lot NumberP000172527
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/10/2023
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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