MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40QC

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Failure to Deliver Shock/Stimulation (1133)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 11/17/2020

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that on (b)(6) 2020, ventricular tachycardia was detected by the implantable cardioverter defibrillator device but the program setting on the device was to monitor, so no therapy was delivered.Also, on (b)(6) 2020, pacing was confirmed, but the atria and ventricle were not captured.On (b)(6) 2020, patient presented in clinic for a device check.Upon review, the implantable cardioverter defibrillator exhibited noise.The reason for the noise was unclear.On (b)(6) 2020, the patient deceased.The physician commented the cause of death seemed to be an irregular pulse.The programming setting on the device was 1 zone setting, the reason was unknown, and the therapy was not delivered due to no setting zone.The patient might have passed away due to continued ventricular tachycardia.

Manufacturer Narrative

Correction: b3, b5: death date in initial reports should have been (b)(6) 2020.Not (b)(6) 2020.

Event Description

Patient deceased on (b)(6) 2020.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10977946
• MDR Text Key: 220503823
• Report Number: 2017865-2020-22088
• 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: 01/04/2021

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 Date: 01/31/2021
• Device Model Number: CD3371-40QC
• Device Lot Number: A000072695
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death