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

Model Number DTBA1D4

Device Problems Electrical /Electronic Property Problem (1198); Protective Measures Problem (3015)

Patient Problem Syncope (1610)

Event Date 12/25/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6935m62 lead, implanted (b)(6) 2014.

Event Description

It was reported through the patient's clinic that one month earlier the patient received anti-tachycardia pacing (atp) during charging for tachycardia in the ventricular fibrillation (vf) zone.The patient's family reported the patient had passed out during this event.Follow-up with the patient's clinic indicated there was a reprogramming that was planned to address the initial event.Patient was scheduled at another clinic to complete this reprogramming but original clinic has not been notified this has been completed.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6470083
• MDR Text Key: 72074393
• Report Number: 3004209178-2017-07714
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

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: Lay User/Patient
• Device Expiration Date: 03/28/2015
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 01/26/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 10/07/2013
• 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
• Treatment: 419488 LEAD, 5076-52 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 82 YR