MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA2D1

Device Problems Mechanical Problem (1384); Misconnection (1399); Over-Sensing (1438)

Patient Problems Cardiac Arrest (1762); Discomfort (2330); Palpitations (2467)

Event Date 11/16/2016

Event Type  malfunction  

Event Description

It was reported that the patient presented with heart palpitations and chest discomfort, along with asystole and cardiac arrest due to oversensing.It was noted by the physician that there was a loose right ventricular (rv) lead pin due to the implant procedure, along with a grommet/setscrew issue with the cardiac resynchronization therapy defibrillator (crt-d).The crt-d was explanted and replaced and the rv lead remains in use.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 EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6316901
• MDR Text Key: 67249786
• Report Number: 9614453-2017-00153
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010031
• 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: 11/16/2016

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: 12/28/2016
• Device Model Number: DTBA2D1
• Device Catalogue Number: DTBA2D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: 11/16/2016
• Supplement Dates FDA Received: 09/28/2017
• Date Device Manufactured: 07/09/2015
• 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: 6947 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR