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

Model Number CD3357-40Q

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Cardiac Arrest (1762); Death (1802); Dizziness (2194); Loss of consciousness (2418)

Event Date 04/03/2017

Event Type  Death  

Event Description

It was reported by the patient¿s wife that the patient expired.The cause of death is unknown.The patient's wife stated that the patient mentioned to have felt dizzy while driving and was able to pull over before losing consciousness.When the ambulance arrived external defibrillation was performed due to the device not delivering therapy for an arrhythmia.The patient was taken to the emergency room and was in sinus rhythm upon arrival.Additionally, it was also stated that the device was interrogated and reprogrammed while in the emergency room.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.

Manufacturer Narrative

Maude report number; mw5070717.

Event Description

New information received states that the patient went into cardiac arrest prior to passing away.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6646448
• MDR Text Key: 77726982
• Report Number: 2938836-2017-29200
• 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: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2017,08/10/2017

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: 05/31/2018
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000023344
• Other Device ID Number: 05414734508216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2017
• Date Report to Manufacturer: 07/05/2017
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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: 73 YR