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

Model Number DTBA2D1

Device Problems Failure to Deliver Shock/Stimulation (1133); Capturing Problem (2891)

Patient Problem Ventricular Tachycardia (2132)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A journal article was reviewed that contained information regarding a cardiac resynchronization therapy defibrillator (crt-d).It was reported that the patient experienced ventricular tachycardia (vt).When a test pace would occur, it was interrupted by ventricular sensing and pacing due to prolonged atrioventricular intervals.The capture threshold test was aborted due to sustained monomorphic vt.It was initially thought that the capture management test was causing vt since it postponed therapy for a relatively long time, resulting in the vt, however, it was determined that capture management was functioning as programmed.The device remains inuse.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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9373972
• MDR Text Key: 168278468
• Report Number: 2182208-2019-02118
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• 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: 09/23/2019
• Initial Date FDA Received: 11/26/2019
• Date Device Manufactured: 08/29/2017
• 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): Other
• Patient Age: 58 YR