• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC EUROPE SARL VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number C6TR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930)
Event Date 01/20/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 429688 lead, implanted: (b)(6) 2017; cmrm6122 envelope. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced a pocket infection and erosion following implant of the cardiac resynchronization therapy pacemaker (crt-p) and the absorbable antibacterial envelope. It was noted the patient had been hospitalized for many weeks for other health issues and the infection was noticed during the hospital stay. Cultures were taken and the organism was identified as micrococcus luteus. The crt-p was removed, along with the left ventricular (lv) lead. The epicardial right ventricular (rv) lead was cut and partially removed. The system was not replaced. No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7413767
MDR Text Key104923435
Report Number9614453-2018-00705
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
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2018
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
Treatment
5071-53 LEAD
-
-