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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 Intermittent Capture (1080)
Patient Problem Syncope/Fainting (4411)
Event Date 08/28/2021
Event Type  Injury  
Event Description
Related manufacturer reference number: 2017865-2021-29737 and 2017865-2021-29738.It was reported that a loss of capture was observed on the device.The patient experienced syncope due to the event.The device was explanted and replaced to resolve the event.The patient was stable.
 
Manufacturer Narrative
Upon receipt, the device was above the elective replacement indicator (eri).Intermittent capture was not confirmed on the bench.Testing found the device to be normal.No anomalies were found.
 
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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 Key12470930
MDR Text Key271374386
Report Number2017865-2021-29735
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 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model NumberCD3371-40QC
Device Lot NumberP000107127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/14/2021
Supplement Dates Manufacturer Received10/21/2021
Supplement Dates FDA Received10/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OPTISURE ACTIVE FIXATION; QUARTET; OPTISURE ACTIVE FIXATION; QUARTET
Patient Outcome(s) Required Intervention;
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