MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40Q

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

Patient Problems Cardiomyopathy (1764); Congestive Heart Failure (1783); Death (1802); Ventricular Tachycardia (2132)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient expired.There is no known allegation from a health professional that the death was related to the device.No further information is available at this time.

Event Description

New information received notes that primary cause of death was congestive heart failure (chf) with ventricular tachycardia (vt) and familial cardiomyopathy.The death was not procedure, pulse generator, the system or study related.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5204680
• MDR Text Key: 30515541
• Report Number: 2938836-2015-31133
• Device Sequence Number: 1
• Product Code: NIK
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

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: 01/31/2013
• Device Model Number: CD3231-40Q
• Device Lot Number: 3450610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2011
• 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)
• Patient Outcome(s): Death