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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ENTRANT HF; No Match
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ABBOTT ENTRANT HF; No Match Back to Search Results
Model Number CDHFA300Q
Device Problem Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Manufacturer Narrative
Further information was requested but not received.
 
Event Description
It was reported that post-paced t-wave oversensing was observed on the device.Abbott technical support recommended reprogramming to resolve the event, however, no intervention has been performed at this time to resolve the event.The patient was in stable condition and will continue to be monitored.
 
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Brand Name
ENTRANT 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 Key18415666
MDR Text Key331576010
Report Number2017865-2023-95694
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032850
UDI-Public05415067032850
Combination Product (y/n)N
Reporter Country CodeGM
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 12/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Model NumberCDHFA300Q
Device Lot NumberP000140114
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2022
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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