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

Model Number CD3371-40QC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/16/2020

Event Type  Death  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

While at home, the patient experienced an episode of ventricular fibrillation (vf) and the device appropriately delivered high voltage (hv) therapy.Shortly after, the patient entered vf again, however, no hv therapy was delivered as the patient's rhythm slowed and fell below the detection zone of the device.The patient later expired due to the arrhythmia.The physician did not believe a device malfunction occurred, however the device will be analyzed to rule out device involvement.The device will be returned for analysis.

Manufacturer Narrative

The device was returned for evaluation after the patient was reported to have expired.Ate testing was performed and the device was normal.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10206547
• MDR Text Key: 196779253
• Report Number: 2938836-2020-07143
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

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 Date: 10/31/2017
• Device Model Number: CD3371-40QC
• Device Lot Number: A000012671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death