MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO VIVA¿ XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D1

Device Problem Pacing Problem (1439)

Patient Problems Bradycardia (1751); Weakness (2145); Complaint, Ill-Defined (2331)

Event Date 08/18/2014

Event Type  Injury  

Event Description

It was reported that the patient was having a slow heart rate and not feeling well.The patient was having weakness during the bradycardia episodes.It was found that the right ventricular (rv) lead was t-wave oversensing.The t-wave oversensing was interfering with the pacing timing of the device which was causing the patient to have periodic heart rates in the low fifties when the device¿s programmed lower rate was at seventy.Reprogramming was done and the device and rv lead remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant medical products: 694765 lead implanted: (b)(6) 2009 ; 4244 competitor lead implanted: (b)(6) 2005.(b)(4).

Manufacturer Narrative

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

Event Description

It was further reported that the cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced.

• Brand Name: VIVA¿ XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; road 31, km. 24, hm 4; ceiba norte industrial park; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4158610
• MDR Text Key: 15814001
• Report Number: 3004209178-2014-18946
• Device Sequence Number: 1
• Product Code: NIK
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2015
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Date Device Manufactured: 11/11/2013
• 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: 419478 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00083 YR
• Patient Weight: 79