MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D1

Device Problems Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)

Patient Problems Chest Pain (1776); Ventricular Tachycardia (2132)

Event Date 10/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 419488, lead, implanted (b)(6) 2008.Etlw1616c124e, stent grafts x2, implanted (b)(6) 2015.Etlw1616c82e, stent graft, implanted (b)(6) 2015.Etbf2816c166e, stent graft, implanted (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency department with chest pain.A review of the transmission noted possible therapy withheld for a ventricular tachycardia (vt) episode detected by the cardiac resynchronization therapy defibrillator (crt-d)as supra ventricular tachycardia (svt) and right atrial (ra) lead under sensing.The device and ra 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10733881
• MDR Text Key: 213019490
• Report Number: 3004209178-2020-18652
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007246
• UDI-Public: 00643169007246
• 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
• Report Date: 10/26/2020

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: 05/28/2017
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/26/2020
• Date Device Manufactured: 12/03/2015
• 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: 694758 LEAD, 5076-45 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 86 YR
• Patient Weight: 71