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

Model Number CD3365-40Q

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

Patient Problems Congestive Heart Failure (1783); Death (1802); High Blood Pressure/ Hypertension (1908); Respiratory Distress (2045)

Event Date 04/22/2018

Event Type  Death  

Event Description

It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests the death was device related.The cause of death was congestive heart failure, asystole due to respiratory distress, diabetes type 2 and hypertension.No additional information was reported.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7640338
• MDR Text Key: 112407134
• Report Number: 2017865-2018-09308
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000010807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• 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
• Patient Age: 77 YR