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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; NO MATCH
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; NO MATCH Back to Search Results
Model Number CDHFA500Q
Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that during an implant procedure, the implantable cardioverter defibrillator alleged to have a missing septum or a detached septum.A new device was used to complete the procedure.No further patient consequences were reported.
 
Manufacturer Narrative
Correction: h6: codes should reflect product not returned.
 
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Brand Name
GALLANT HF
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 Key17330241
MDR Text Key319510880
Report Number2017865-2023-35906
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032010
UDI-Public05415067032010
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 Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA500Q
Device Catalogue NumberCDHFA500Q
Device Lot NumberA000137289
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2023
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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