• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3371-40QC
Device Problems Failure to Convert Rhythm (1540); Inappropriate or Unexpected Reset (2959)
Patient Problem Arrhythmia (1721)
Event Date 01/13/2023
Event Type  Injury  
Event Description
It was reported the patient was admitted to the intensive care unit due to a ventricular tachycardia storm.The device provided appropriate shocks, however, the shocks were unsuccessful in terminating the electrical storm.The high voltage therapy on the device was deactivated and an external defibrillator was used to terminate the arrhythmia.Additionally, following the event, the device was in back up mode.Technical support was contacted and recommended reprogramming to resolve the event.Technical support suspected the back up mode was due to the use of the external defibrillator.The device was reprogrammed.There were no consequences to the patient due to the device.
 
Manufacturer Narrative
The reported event of the patient being in a ventricular tachycardia (vt) storm that was unable to be terminated successfully by the device was confirmed.The device delivered multiple atp and high voltage therapy for repeated arrhythmia, but was unsuccessful.It was confirmed that the device was sensing appropriately during this time and was performing by design.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUADRA ASSURA MP ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key16235514
MDR Text Key308028271
Report Number2017865-2023-02981
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/22/2023
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 Date09/30/2020
Device Model NumberCD3371-40QC
Device Lot NumberA000076230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/16/2023
Initial Date FDA Received01/24/2023
Supplement Dates Manufacturer Received02/07/2023
Supplement Dates FDA Received02/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-