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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumothorax (2012)
Event Date 03/02/2021
Event Type  Injury  
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.
 
Event Description
Related manufacturer reference number: 2017865-2021-12747; 2017865-2021-12760; 2017865-2021-12761.It was reported that the patient developed pneumothorax post implantation.No further information was available.
 
Event Description
New information states that pneumothorax was observed 1-day post implant procedure.The issue was resolved without any complications.No intervention was performed.
 
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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 Key11563859
MDR Text Key242068073
Report Number2017865-2021-12750
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
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model NumberCD3371-40QC
Device Lot NumberA000091427
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OPTISURE ACTIVE FIXATION,; QUARTET LEAD DOUBLE BEND; TENDRIL STS; OPTISURE ACTIVE FIXATION,; QUARTET LEAD DOUBLE BEND; TENDRIL STS
Patient Outcome(s) Other;
Patient Age55 YR
Patient Weight48
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