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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ENTRANT DR; No Match
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ABBOTT ENTRANT DR; No Match Back to Search Results
Model Number CDDRA300Q
Device Problem Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2024
Event Type  malfunction  
Event Description
During in-clinic follow up, oversensing of myopotentials was observed on the device.Technical support was contacted and recommended reprogramming to resolved the event.No intervention has been performed.The patient was stable and will continue to be monitored.
 
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Brand Name
ENTRANT DR
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 Key19008450
MDR Text Key338980181
Report Number2017865-2024-37033
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05415067032843
UDI-Public05415067032843
Combination Product (y/n)N
Reporter Country CodeIT
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 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Model NumberCDDRA300Q
Device Lot NumberS000077871
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2020
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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