MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number C6TR01

Device Problems Mechanical Problem (1384); Over-Sensing (1438)

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

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was returned and analyzed. Returned product analysis was performed and no anomalies were found. The returned device indicated a damaged grommet. The returned device indicated foreign material on set screw. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, right ventricular (rv) lead oversensing was noted after the cardiac resynchronization therapy pacemaker (crt-p) was connected. The rv oversensing could be replicated with header manipulation when the device was in the pocket, but could not be replicated when the device was outside the pocket. The rv lead was removed from the device and reconnected, but similar rv oversensing was still noted. The rv lead was disconnected and tested with an analyzer and electrical parameters were the same as those prior to the original connection of the device. The physician manipulated the proximal end of the lead, including tie-down sleeve, and no oversensing was noted. It was concluded that the problem was in the header of the can and not the rv lead itself. The device was not used and replaced with no oversensing noted. No patient complications have been reported as a result of this event.

• Brand Name: VIVA XT CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• 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: 6923890
• MDR Text Key: 100064664
• Report Number: 9614453-2017-03720
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2018
• Device Model Number: C6TR01
• Device Catalogue Number: C6TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial