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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 10/05/2023
Event Type  malfunction  
Event Description
It was reported that the patient presented during magnetic resonance imaging(mri).During mri, the implantable cardioverter defibrillator was found in back mode due to mri procedures not properly followed.Programming changes were performed.The patient was in stable condition.
 
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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 Key17999463
MDR Text Key326564666
Report Number2017865-2023-50544
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032003
UDI-Public05415067032003
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,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDDRA500Q
Device Lot NumberP000146830
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2022
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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