MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D1

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/27/2015

Event Type  Death  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported by the patient's family member that the patient died in a car accident while driving and that the device contributed to the patient's death.Follow up was conducted to obtain additional information about the patient's device and death.The patient was last seen approximately five months prior to their death for a device check.No performance issues were noted at that time and the device appeared to be functioning normally.No other information is available at this time.Cause of death has not yet been determined.

Manufacturer Narrative

Product event summary: the device was returned, analyzed and no anomalies were found.

• Brand Name: VIVA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5336473
• MDR Text Key: 34734619
• Report Number: 3004209178-2015-25793
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2015
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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): Death
• Patient Age: 00083 YR