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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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ST. JUDE MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number CD3365-40Q
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
It was reported that this lead was explanted due to product performance issue.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17988113
MDR Text Key326379808
Report NumberMW5147263
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 10/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberCD3365-40Q
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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