MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 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); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 07/02/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient expired.The patient was admitted with acute kidney injury and hypoglycemia.During admission the patient had ventricular tachycardia episodes with hemodynamic instability and altered mental status.A vt ablation was done on (b)(6) 2016.The patient did well until (b)(6) 2016 when he developed vt that degenerated to ventricular fibrillation and was shocked 3 times.He continued to have vt and treated with an amiodarone drip.Patient was changed to comfort measures only and expired on (b)(6) 2016.There is no known allegation from a health professional that suggests the death was related to the device.No further information is available.

Event Description

New information received notes that the cause of death was acute respiratory failure, cardiac arrhythmia, ventricular tachycardia, cardiomyopathy, and coronary artery disease.

• 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: 6215895
• MDR Text Key: 63652979
• Report Number: 2938836-2016-24007
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: CD3357-40C
• Device Lot Number: 4912815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• 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)
• Patient Outcome(s): Death
• Patient Age: 73 YR