MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA¿ QUAD S CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBB2QQ

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Death (1802); Fall (1848); Ventricular Tachycardia (2132); Brain Injury (2219)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient's ventricular tachycardia (vt) was untreated by the cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead resulting in a fall, brain injury and admission to a nursing home.A similar incident subsequently took place and the patient died.It did appear that the patient had vt in the monitor zone but it could not be definitively determined that it was related to the patient's death.No further information was reported.

• Brand Name: VIVA¿ QUAD S CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8641044
• MDR Text Key: 146086090
• Report Number: 9614453-2019-01696
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2016
• Device Model Number: DTBB2QQ
• Device Catalogue Number: DTBB2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/24/2019
• Date Device Manufactured: 11/07/2014
• 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: 6947M LEAD, 4598 LEAD
• Patient Age: 78 YR