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

Model Number CD3357-40Q

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Programming Issue (3014)

Patient Problems No Known Impact Or Consequence To Patient (2692); Shock from Patient Lead(s) (3162)

Event Date 03/30/2017

Event Type  Injury  

Event Description

It was reported that the patient presented in hospital.Upon interrogation, the patient experienced unexpected shocks due to inappropriate programming.Shocks were delivered to treat supraventricular tachycardia as ventricular tachycardia.Programming changes were made.The patient was in stable condition after reprogramming.

Manufacturer Narrative

Patient code should have been (b)(4) rather than (b)(4).

• 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: 6642059
• MDR Text Key: 77601945
• Report Number: 2017865-2017-04991
• 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: 07/03/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000021333
• Other Device ID Number: 05414734508216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 07/03/2017
• Supplement Dates FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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): Required Intervention
• Patient Age: 81 YR