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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; No Match
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ABBOTT QUADRA ASSURA MP ICD; No Match Back to Search Results
Model Number CD3371-40QC
Device Problems Failure to Interrogate (1332); No Pacing (3268)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  Injury  
Event Description
It was reported that during a follow up in clinic, the device was unable to be interrogated.Loss of pacing was noted.Abbott technical support was contacted and the device was explanted and replaced to resolve the event.The patient was in stable condition.
 
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Brand Name
QUADRA ASSURA MP 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 Key18653637
MDR Text Key334694201
Report Number2017865-2024-03881
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodePL
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 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCD3371-40QC
Device Lot NumberA000125800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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