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

Model Number CD3371-40QC

Device Problems Over-Sensing (1438); Under-Sensing (1661)

Patient Problem Death (1802)

Event Date 04/09/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient expired due to sudden cardiac death.The device delivered high voltage therapy and anti-tachycardia pacing (atp).Abbott technical support was contacted and observed that undersensing and oversensing occurred due to an agonal or slow ventricular rhythm.There was no suspected malfunction on the device.

Manufacturer Narrative

The device was returned for analysis.Interrogation of the device revealed the device was above the elective replacement indicator when received.The device was tested on the bench and no electrical, mechanical or functional anomalies were observed.Telemetry, impedance, sensing, pacing and high voltage delivery functions were found to be normal.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10191807
• MDR Text Key: 196314838
• Report Number: 2938836-2020-07049
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: CD3371-40QC
• Device Lot Number: A000061178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death