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

Model Number CD3371-40

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

Patient Problems Death (1802); Heart Failure (2206)

Event Date 06/22/2017

Event Type  Death  

Event Description

It was reported that the patient expired due to the heart failure on (b)(6)2017.The patient experienced ventricular tachycardia during the implant procedure on (b)(6)2017.The ventricular tachycardia continuously occurred when the patient presented in the intensive care unit.There is no known allegation from a health professional that suggests the death was related to the device.

Manufacturer Narrative

This supplemental report is to correct the initial mdr report type: death.

Event Description

New information received states that the physician believed that the device was able to recognize the ventricular tachycardia and deliver the therapy properly.However, the physician considered that too many high voltage therapies would drain the battery so he decided to turn off the therapy.

• 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
• 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: 6710753
• MDR Text Key: 79942978
• Report Number: 2017865-2017-06385
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/11/2017

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: 03/31/2019
• Device Model Number: CD3371-40
• Device Lot Number: S000032840
• Other Device ID Number: 05414734508391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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); 1944/52, (B)(4); 7122/65, (B)(4)
• Patient Outcome(s): Death