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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 CD3361-40C
Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Arrhythmia (1721)
Event Date 11/05/2023
Event Type  Injury  
Event Description
During follow-up, inappropriate antitachycardia pacing was delivered due to atrial fibrillation.Abbott technical support was contacted and recommended reprogramming the device.No intervention was performed at this time.The patient was in stable condition.
 
Event Description
Additional information was received indicating that the device was reprogrammed.
 
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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 Key18191874
MDR Text Key328803274
Report Number2017865-2023-73000
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUK
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model NumberCD3361-40C
Device Lot NumberS000026983
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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