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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3367-40QC
Device Problem Insufficient Information (3190)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
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.Further information was requested but not received.
 
Event Description
It was reported that during the implant procedure, an unspecified malfunction occurred with the implantable cardioverter defibrillator.Further information was requested but not received.
 
Manufacturer Narrative
The device was tested on the bench, and no anomalies were found.
 
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Brand Name
QUADRA ASSURA 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 Key10690610
MDR Text Key211685932
Report Number2017865-2020-15593
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,distri
Type of Report Initial,Followup
Report Date 02/08/2021
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 Date01/31/2022
Device Model NumberCD3367-40QC
Device Lot NumberP000096792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/24/2020
Initial Date FDA Received10/16/2020
Supplement Dates Manufacturer Received01/20/2021
Supplement Dates FDA Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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