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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; No Match Back to Search Results
Model Number CDDRA500Q
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2023
Event Type  malfunction  
Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found the ventricular septum of device was loose and detached.
 
Event Description
This report is to advise of an event observed during analysis.
 
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Brand Name
GALLANT DR
Type of Device
No Match
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18352262
MDR Text Key330833620
Report Number2017865-2023-95009
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032003
UDI-Public05415067032003
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberCDDRA500Q
Device Lot NumberA000136670
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2023
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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