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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ABBOTT QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3367-40QC
Device Problems Loose or Intermittent Connection (1371); Sensing Intermittently (1558); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Event Description
During the initial implant procedure, the set screw could not be tightened which resulted in an unspecified sensing issue the device was explanted and replaced to resolve the event.The patient was stable.
 
Event Description
During the initial implant procedure, the set screw could not be tightened which resulted in intermittent sensing.The device was explanted and replaced to resolve the event.The patient was stable.
 
Manufacturer Narrative
The reported events of set screw anomaly and sensing anomaly could not be confirmed in the lab.Interrogation of the device revealed the device was above the elective replacement indicator when received.Pacing, sensing, impedance, hv output, and patient notifier were tested and no anomaly was detected.The cause of the field event remains undetermined.
 
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Brand Name
QUADRA ASSURA ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key11628887
MDR Text Key244246719
Report Number2017865-2021-13746
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,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model NumberCD3367-40QC
Device Lot NumberP000102526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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