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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 CD3371-40QC
Device Problem Over-Sensing (1438)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information was requested but not yet received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that the cardioverter defibrillator was oversensing post-paced t-waves.
 
Event Description
Additional information - it was reported that there were no patient consequences, and the patient would continue to be monitored.
 
Manufacturer Narrative
Correction: please retract this report mdr-2020-55801, the same issue was previously reported as mdr-2021-00202.
 
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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
MDR Report Key11099254
MDR Text Key224521740
Report Number2017865-2020-25321
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Model NumberCD3371-40QC
Device Lot NumberA000097342
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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