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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 Failure to Interrogate (1332); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2024
Event Type  malfunction  
Event Description
Prior to an initial implant procedure, an error message was received and the device was unable to be interrogated using inductive or bluetooth (ble) telemetry.The device was replaced to resolve the event.The patient was stable and will continue to be monitored.
 
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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 Key18960258
MDR Text Key338372981
Report Number2017865-2024-35649
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067031990
UDI-Public05415067031990
Combination Product (y/n)N
Reporter Country CodeUK
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 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDVRA500Q
Device Lot NumberP000161217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2023
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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