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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CDHFA500Q
Device Problem Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2023
Event Type  malfunction  
Event Description
During a clinic follow-up, episodes of post-paced t wave oversensing were observed on the device.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.
 
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Brand Name
GALLANT HF
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key16457693
MDR Text Key310405851
Report Number2017865-2023-11379
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 Nurse
Type of Report Initial
Report Date 02/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA500Q
Device Catalogue NumberCDHFA500Q
Device Lot NumberP000156937
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2022
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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