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

Model Number CD3265-40Q

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient¿s daughter that the patient expired as a result of allegedly failed device.The patient had four small heart attacks the day before his death.The device functioned properly and brought him out of his arrhythmias.However, the following day the patient had a massive heart attack and was pronounced dead.The massive heart attack was due to so much fluid build-up from the prior heart attacks.There is no known allegation from a health professional that suggests the death was related to the device.No further information is available at this time.

• Brand Name: QUADRA ASSURA (DDQP+)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6131986
• MDR Text Key: 61024088
• Report Number: 2938836-2016-14710
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: CD3265-40Q
• Device Lot Number: 3987317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• 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: (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Death