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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
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.
 
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Brand NameVIVA XT CRT-P
Type of DevicePULSE 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 Key6923890
MDR Text Key100064664
Report Number9614453-2017-03720
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
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 Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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