MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA2Q1

Device Problems Mechanical Problem (1384); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: 4298 lead implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's right ventricular (rv) lead had high thresholds, and high and undefined pacing impedance.A complete lead revision was initially planned, however after removal of the pace/sense part of the lead, it was noted that there was blood in the ring of the lead and a defect with the sealing lip.The lead was cleaned and connection re-established with silicone.The lead is still in use.As well, the patient's device was reported to have blood in the connector while reconnecting.The device is still in use.No patient complications have been reported as a result of this event.

• Brand Name: VIVA QUAD XT
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7461143
• MDR Text Key: 106603746
• Report Number: 9614453-2018-01556
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2017
• Device Model Number: DTBA2Q1
• Device Catalogue Number: DTBA2Q1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/25/2018
• Date Device Manufactured: 09/29/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 95