MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3365-40C

Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661); Decreased Sensitivity (2534)

Patient Problems Syncope (1610); Death (1802); Fainting (1847); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 08/18/2017

Event Type  Death  

Event Description

It was reported that the patient experienced ventricular tachycardia (vt) and ventricular fibrillation (vf).The patient had passed out and was then intubated in the coronary care unit.During this time, the patient experienced several appropriate high voltage therapies from their implantable defibrillator.Upon review of the stored electrograms, events of undersensing, decreased high voltage sensitivity and failure to convert rhythm were observed.The patient¿s family withdrew care and the patient expired on (b)(6) 2017.There is no known allegation from a health care professional that suggests that the death was device related.The cause of death was unknown.

Manufacturer Narrative

This supplemental report is to correct in initial mdr."required intervention to prevent permanent impairment/damage (devices)" was wrongfully checked.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6868721
• MDR Text Key: 86305348
• Report Number: 2017865-2017-32015
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: CD3365-40C
• Device Catalogue Number: CD3365-40C
• Device Lot Number: 4883328
• Other Device ID Number: 05414734508261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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
• Treatment: 1458Q/86, (B)(4) ; 1688TC/58, (B)(4) ; 7122/60, (B)(4)
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 72 YR