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

Model Number CD3211-36

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

Patient Problems Death (1802); Myocardial Infarction (1969); Respiratory Failure (2484)

Event Date 07/18/2016

Event Type  Death  

Event Description

It was reported that the patient expired.The patient was examined and it was noted they were experiencing acute respiratory failure and non st segment myocardial infarction.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is unknown.

• Brand Name: PROMOTE PLUS CRT-D
• 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: 6912831
• MDR Text Key: 88101836
• Report Number: 2938836-2017-32469
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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
• Report Date: 10/03/2017

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: 01/31/2011
• Device Model Number: CD3211-36
• Device Lot Number: 2833091
• Other Device ID Number: 05414734503693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2009
• 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: 75 YR