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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CDVRA500Q
Device Problems Inappropriate or Unexpected Reset (2959); Compatibility Problem (2960)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2022
Event Type  malfunction  
Event Description
It was reported the patient presented in clinic for follow up.Upon interrogation, it was noted the implantable cardioverter defibrillator (icd) entered backup mode after a magnetic resonance imaging (mri) scan.The icd was successfully restored.The patient was in stable condition.
 
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Brand Name
GALLANT VR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key15533873
MDR Text Key306110617
Report Number2017865-2022-40272
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067031990
UDI-Public05415067031990
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
Report Date 10/03/2022
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 Date04/30/2023
Device Model NumberCDVRA500Q
Device Catalogue NumberCDVRA500Q
Device Lot NumberS000082458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/22/2022
Initial Date FDA Received10/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
OPTISURE MRI
Patient Age37 YR
Patient SexMale
Patient Weight147 KG
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