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

Model Number CD3257-40

Device Problems No Device Output (1435); Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported when the patient presented to the hospital after implantation of a new lvad device, the patient did not respond well to an initiated ventricular tachycardia.Appropriate antitachycardia pacing therapy could not convert the arrhythmia to sinus.Ventricular nips were used to terminate the rhythm.Additional therapies were added to the programming settings.The patient condition was stable.The patient will continue to be monitored.

Manufacturer Narrative

Analysis was normal.The device was tested on the bench and no anomalies were found.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5461035
• MDR Text Key: 39042458
• Report Number: 2938836-2016-01624
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• 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,Followup
• Report Date: 09/30/2017

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: 03/31/2015
• Device Model Number: CD3257-40
• Device Catalogue Number: CD3257-40
• Device Lot Number: 4256220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: 07/21/2017; 09/28/2017
• Supplement Dates FDA Received: 08/14/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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: 60 YR