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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 Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543)
Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Heart Failure/Congestive Heart Failure (4446)
Event Date 12/07/2023
Event Type  malfunction  
Event Description
It was reported that the device withheld high-voltage (hv) therapy due to an incorrect interpretation of signal.Technical support was contacted, but no intervention has been performed at this time.The patient was stable and will continue to be monitored.
 
Event Description
Additional information was received that an ablation procedure was performed to resolve the event.The patient was stable.
 
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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 Key18355688
MDR Text Key330930873
Report Number2017865-2023-95079
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 Physician
Type of Report Initial,Followup
Report Date 01/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model NumberCDHFA500Q
Device Lot NumberS000080278
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2020
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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