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

Model Number DTBA2D4

Device Problem Failure to Capture (1081)

Patient Problem Cardiac Arrest (1762)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 6935m62, serial#: (b)(4).Product id: 383069, serial#: (b)(4), implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that approximately one month following implant, the patient was experiencing symptoms and a holter test was performed.It was noted the right ventricular (rv) lead output had been programmed subthreshold with left ventricular (lv) lead only pacing through his bundle pacing.Asystole was observed on the holter and it was added the device was utilizing rv only pacing during atrial capture management testing, however, the rv subthreshold programming resulted in no ventricular pacing support during the time of testing.The rv output was programmed off and the lv output was reprogrammed to a lower value, which improved the capture threshold in clinic.The rv lead and lv lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA¿ XT CRT-D
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9821993
• MDR Text Key: 183517196
• Report Number: 9614453-2020-00905
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2019
• Device Model Number: DTBA2D4
• Device Catalogue Number: DTBA2D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Date Device Manufactured: 06/01/2018
• 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): Life Threatening; Required Intervention