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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 Problems Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Discomfort (2330)
Event Date 03/07/2024
Event Type  malfunction  
Event Description
During remote follow up, far field r wave oversensing which resulted in inappropriate automatic mode switch (ams) was observed on the device.The patient experienced discomfort during physical activity due to the ams.Technical support was contacted and the device was reprogrammed to resolve the event and patient discomfort.The patient was stable.
 
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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 Key18990383
MDR Text Key338779576
Report Number2017865-2024-36944
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032850
UDI-Public05415067032850
Combination Product (y/n)N
Reporter Country CodeSW
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 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCDHFA300Q
Device Lot NumberS000088245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2022
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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