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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 CD3371-40C
Device Problem Over-Sensing (1438)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2020
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 monitoring, myopotential oversensing was observed on the device.Abbott technical support was contacted, and the device was reprogrammed to resolve the event.The patient was in stable condition.
 
Event Description
Additional information received indicated no new episodes of myopotential oversensing were observed on the device, however, the device was reprogrammed.The patient was in stable condition.
 
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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 Key11178537
MDR Text Key227063422
Report Number2017865-2021-02193
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 06/23/2021
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 Date04/30/2020
Device Model NumberCD3371-40C
Device Lot NumberP000062603
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/08/2021
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received06/20/2021
Supplement Dates FDA Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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