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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GALLANT VR; No Match
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ABBOTT GALLANT VR; No Match Back to Search Results
Model Number CDVRA500Q
Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Patient Problem Discomfort (2330)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
During an in-clinic follow-up, the device entered backup vvi (bvvi) after the patient underwent a magnetic resonance imaging (mri) procedure without programming the device into mri mode prior to the procedure.High voltage therapy was unavailable while the device was in bvvi mode.The patient experienced uncomfortable pacing as a result of the bvvi.Abbott technical support was contacted, and the device was reprogrammed to resolve the event.The patient was in stable condition.
 
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Brand Name
GALLANT VR
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18721909
MDR Text Key335589545
Report Number2017865-2024-32848
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/16/2024
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 Model NumberCDVRA500Q
Device Lot NumberS000089489
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/01/2024
Initial Date FDA Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2023
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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