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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; No Match Back to Search Results
Model Number CDVRA500Q
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 07/01/2022
Event Type  malfunction  
Manufacturer Narrative
Sus voluntary even report was received.Medwatch: mw5147630, mw5147631, mw5147632, mw5147633.
 
Event Description
Related manufacturing reference number: 2017865-2023-94829 related manufacturing reference number: 2017865-2023-94830 related manufacturing reference number: 2017865-2023-94832 it was reported via the food and drug association (fda) medwatch program that the patient had an implantable cardioverter defibrillator (icd) and right ventricular (rv) lead that both exhibited an unspecified failure.The icd and rv lead were both explanted and replaced, but the new icd and rv lead also exhibited and unspecified failure.The newly implanted icd and rv lead were deactivated.Further information was not provided.
 
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Brand Name
GALLANT VR
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 Key18336807
MDR Text Key330615135
Report Number2017865-2023-94831
Device Sequence Number1
Product Code NIK
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 Other
Type of Report Initial
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDVRA500Q
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/24/2023
Initial Date FDA Received12/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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