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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT UNIFY ASSURA ICD; No Match
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ABBOTT UNIFY ASSURA ICD; No Match Back to Search Results
Model Number CD3361-40QC
Device Problems Over-Sensing (1438); Pacing Asynchronously (1441)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2024
Event Type  malfunction  
Event Description
During remote monitoring, episodes of post-paced t-wave oversensing due to fusion were observed on the device.Abbott technical support was contacted and recommended reprogramming, however, no intervention was performed at this time.The patient was stable and will continue to be monitored.
 
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Brand Name
UNIFY ASSURA ICD
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 Key18933189
MDR Text Key338066046
Report Number2017865-2024-35349
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeSP
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 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberCD3361-40QC
Device Lot NumberP000127585
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2021
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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