MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA QUAD XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVER

Model Number DTBA2QQ

Device Problems Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Cardiomyopathy (1764)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient had effort/exercise intolerance.It was further reported the patient had ¿toxic¿ cardiomyopathy and the physician questioned if this was related to the device pacing/sensing functionality.The device remains in use.No further patient complications have been reported as a result of this event.The patient is a participant in a clinical study.

• Brand Name: VIVA QUAD XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11875793
• MDR Text Key: 252364591
• Report Number: 9614453-2021-02140
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2017
• Device Model Number: DTBA2QQ
• Device Catalogue Number: DTBA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2021
• Date Device Manufactured: 03/17/2016
• 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: 4076 LEAD, 6935M LEAD, 4298 LEAD
• Patient Outcome(s): Other