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

Model Number CD3357-40C

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

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

Event Date 06/04/2017

Event Type  Death  

Event Description

It was reported that the patient deceased.The cause of death was myocardial infarction.There is no known allegation from a health care professional that suggests that the death was device related.No additional information was reported.

Manufacturer Narrative

Analysis was normal.No anomalies were found.Correction: section d10 " yes" button was not checked in the previous report.

• Brand Name: UNIFY ASSURA CRT-D 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: 6741237
• MDR Text Key: 80952020
• Report Number: 2017865-2017-07117
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

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: 04/30/2017
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000005214
• Other Device ID Number: 05414734508186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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
• Treatment: (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Death
• Patient Age: 71 YR