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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 Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2024
Event Type  malfunction  
Event Description
It was reported that the patient presented for in-clinic follow up with the implantable cardioverter defibrillator in backup operation.No interventions were reported.The patient was stable.
 
Manufacturer Narrative
Further information was requested but not received.
 
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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 Key18792638
MDR Text Key336412990
Report Number2017865-2024-33590
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/27/2024
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 Expiration Date01/31/2024
Device Model NumberCDHFA500Q
Device Lot NumberS000085245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/08/2024
Initial Date FDA Received02/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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