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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 Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2023
Event Type  malfunction  
Event Description
Following an mri procedure the device was observed to be in backup mode due to not programming the device to mri settings in a non-pacemaker dependent patient.Abbott technical support was contacted and the device was reprogrammed 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 Key18121776
MDR Text Key327948591
Report Number2017865-2023-52267
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodePO
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,Followup
Report Date 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model NumberCD3371-40QC
Device Lot NumberP000107047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2020
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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