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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 Problems Fitting Problem (2183); Connection Problem (2900)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2020
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 procedure to implant an implantable cardioverter defibrillator, the lead could not be fixed to the device.The device was replaced.Further information was not available.
 
Manufacturer Narrative
The implantable cardioverter defibrillator was returned for the reported event of unable to connect lead.Analysis revealed the right and left ventricular setscrews were stripped due to procedural damage.Septum debris entered the setscrew hex cavities and prevented the screwdriver from tightening and fully connecting the lead.The reported event was confirmed and attributed to procedural damage.
 
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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 Key10909695
MDR Text Key218494085
Report Number2017865-2020-17707
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 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
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 NumberCD3367-40QC
Device Lot NumberP000103482
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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