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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3371-40QC
Device Problem Failure to Interrogate (1332)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
During remote follow-up, rf interrogation of the device was not possible.Malfunction of the rf function on the device is alleged.An inductive transmitter was sent to the patient to resolve the event.The patient was in stable condition.
 
Event Description
Additional information received indicated the patient was successfully paired to an inductive transmitter and was able to be re-paired to the rf transmitter with successful rf telemetry.The patient will continue to be monitored.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
645 almanor avenue
sunnyvale CA 94085
MDR Report Key11036292
MDR Text Key222293415
Report Number2938836-2020-09756
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Model NumberCD3371-40QC
Device Lot NumberP000090496
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received02/02/2021
Supplement Dates FDA Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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