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

Model Number CD3235-40

Device Problems Premature Discharge of Battery (1057); No Device Output (1435)

Patient Problem Death (1802)

Event Date 06/27/2017

Event Type  Death  

Event Description

It was reported that the patient presented in the emergency room after experiencing multiple ventricular arrhythmias.The cardiac resynchronization therapy defibrillator delivered therapy initially.The device failed to deliver defibrillation therapy for the later ventricular arrhythmias.Upon interrogation, the device had reached elective replacement indicator because of premature battery depletion the same day.The patient had to be defibrillated externally.The patient became clinically unstable and later died during the day.

Manufacturer Narrative

Device was tested on the bench and no anomalies were found.

• Brand Name: UNIFY 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: 6686065
• MDR Text Key: 79050702
• Report Number: 2017865-2017-05942
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: CD3235-40
• Device Catalogue Number: CD3235-40
• Device Lot Number: S000019439
• Other Device ID Number: 05414734503556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Death; Required Intervention