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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 Over-Sensing (1438)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/25/2020
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 a remote follow-up, episodes of noise resulting in myopotential oversensing was observed on the device.Technical support was contacted and recommended reprogramming to resolved the event.No intervention has been performed at this time.The patient was stable and will continue to be monitored.
 
Event Description
Additional information was received indicating that the device was reprogrammed to resolve the event.
 
Manufacturer Narrative
Additional information: b5.
 
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Brand Name
QUADRA ASSURA MP ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key11155828
MDR Text Key226314880
Report Number2017865-2021-01985
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Model NumberCD3371-40QC
Device Lot NumberA000012451
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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