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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 Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Event Description
It was reported that a patient presented to clinic for follow up.Device interrogation revealed that the implantable cardioverter defibrillator (icd) was in backup mode with no therapies active.The physician suspects mri related backup mode due to off-label mri environment.The icd was restored back to normal settings.The patient condition was stable.
 
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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 Key19112260
MDR Text Key340808007
Report Number2017865-2024-38208
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032003
UDI-Public(01)05415067032003(10)P000125342(17)230630
Combination Product (y/n)N
Reporter Country CodeKS
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 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model NumberCDDRA500Q
Device Lot NumberP000125342
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/19/2021
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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