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

Model Number DTBA1D1

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Arrhythmia (1721); Device Overstimulation of Tissue (1991)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 694765 lead, implanted: (b)(6) 2008, product id: 383059 lead, implanted: (b)(6) 2008.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was symptomatic when the cardiac resynchronization therapy defibrillator (crt-d) feature which monitors left ventricular pacing amplitude threshold and adjusts outputs would conduct testing.The patient would experience palpitations and extracardiac stimulation.The device feature was turned off and the crt-d remains in use.The patient is a participant in a clinical study.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: 11759853
• MDR Text Key: 248421408
• Report Number: 3004209178-2021-07047
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169929296
• UDI-Public: 00643169929296
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2021

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: 02/14/2019
• 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: 04/12/2021
• Initial Date FDA Received: 05/03/2021
• Date Device Manufactured: 08/16/2017
• 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
• Treatment: 6996SQ58 LEAD, 4968-60 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR