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

Model Number CD3367-40QC

Device Problem Failure to Convert Rhythm (1540)

Patient Problems Arrhythmia (1721); Death (1802); Ventricular Fibrillation (2130)

Event Date 12/18/2020

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

Related manufacturer reference number: 2017865-2021-00915.It was reported that one day post implant procedure, patient had an episode of ventricular fibrillation.The implantable cardioverter-defibrillator and right ventricular lead delivered defibrillation therapy multiple times but failed to terminate the episode each time.The patient passed away.The device and lead were explanted.

Event Description

New information received noted there was no allegation from the physician that the death was caused by any abbott product or procedure.

Manufacturer Narrative

The reported field event of high voltage output anomaly could not be confirmed in the lab.The stored electrocardiograms (segm) directory in the device image was cleared after the high voltage therapies were delivered.Due to lack of data, the reported field event could not be confirmed.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.Device functionality was bench tested; no anomalies were detected.

• Brand Name: QUADRA ASSURA 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: 11139863
• MDR Text Key: 225764574
• Report Number: 2017865-2021-00866
• 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,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CD3367-40QC
• Device Lot Number: P000103511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Patient Outcome(s): Death