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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GALLANT HF; No Match
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ABBOTT GALLANT HF; No Match Back to Search Results
Model Number CDHFA500Q
Device Problems Pacing Asynchronously (1441); Under-Sensing (1661)
Patient Problem Arrhythmia (1721)
Event Date 09/24/2023
Event Type  malfunction  
Event Description
During an in-clinic follow-up, episodes of undersensing and pacemaker mediated tachycardia were observed on the device.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 HF
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 Key17950294
MDR Text Key325857660
Report Number2017865-2023-49895
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032010
UDI-Public05415067032010
Combination Product (y/n)N
Reporter Country CodeNL
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 Other Health Care Professional
Type of Report Initial
Report Date 10/17/2023
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? No
Device Operator Health Professional
Device Expiration Date05/31/2024
Device Model NumberCDHFA500Q
Device Lot NumberP000146831
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/02/2023
Initial Date FDA Received10/17/2023
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
Patient Sequence Number1
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